cyrilzakka/clinical-trials huggingface dataset:
Step-up to Quit: Using Low-to-moderate Intensity Exercise for Reducing Smoking Cue Reactivity Among Low-income Smokers

The study's primary aim is to test the hypothesis that an intervention that integrates low to moderate physical activity (walking) with evidence-based smoking cessation counseling (LMPA) will result is greater reductions in quit-day reactivity to smoking cues (a behavioral predictor of smoking relapse) as compared to standard care smoking cessation counseling (control group) in a sample of low-income sedentary male and female smokers. The study will also test the hypothesis that the participants randomized to the LMPA intervention will have greater quit rates at one-week and one-month post quit day follow ups.

Tobacco use and lack of physical activity (PA) are preventable health behaviors contributing to disproportionate rates of morbidity/mortality (MM) among low income underserved adults. Comprehensive interventions incorporating treatment of multiple risk behaviors can have immense public health impact. The goal of this study is to improve uptake of PA during the pre-quit period by promoting low to moderate intensity PA (LMPA/walking) during the pre-quit preparatory period to promote smoking cessation among low-income sedentary smokers. Eligible participants (sedentary, \>5 cigs/day) will be randomized to 8-week LMPA vs. standard of care (SCC) intervention. LMPA group intervention focuses on (a) increasing daily steps using a tailored algorithm with a goal of reaching 10,000 steps/day by Week 4 (quit day) and (b) integrates PA with evidence-based smoking cessation programming by explicitly linking short bouts of PA with urge management training during the pre-quit period. The SCC group receives standard care smoking cessation counseling. Group differences in quit day reduction (extinction) of smoking urge reactivity using an analog cue-exposure paradigm, and smoking quit rates at 1-week and 1-month follow-up will be examined.

Eligibility Criteria:
Inclusion Criteria:

* intent-to-treat sedentary male and female smokers (intention to quit within the next 6 months) - - - smoke 6 or more cigarettes per day.
* Sedentary critieria: not purposeful physical activity for less than 20 minutes of vigorous intensity, or less than 60 minutes of moderate intensity physical activity per week, or less than 100 minutes of time spent walking per week.

Exclusion Criteria:

* pregnancy
* current substance abuse (e.g., alcohol, cocaine, or stimulants);
* current diagnosis or treatment of bipolar and psychotic disorder (e.g., use of Haldol, Thorazine).
Penumbra and Recanalisation Acute Computed Tomography in Ischaemic Stroke Evaluation

Stroke affects over 125,000 people each year in the UK and leaves at least 50% disabled. Treatment of stroke caused by a blockage in a blood vessel (ischaemic stroke), with clotbusting drugs improves the chances of good recovery, but must be given within 4.5 hours of onset. Currently only a small proportion of patients who arrive in hospital within 4.5 hours are treated. This is largely due to uncertainty about diagnosis and concerns about risk of bleeding associated with clotbusting medication. Patients with mild or improving symptoms in particular are often not treated because of uncertainty about relative risks and benefits. However, around one third of these patients go on to be significantly disabled. Routine CT scanning often does not show abnormalities in acute stroke (which take hours to become easily visible), and cannot show the extent or severity of blood flow changes in ischemic stroke.

We wish to investigate the value of additional CT scanning that gives information on the blood vessels (angiography, CTA) and blood flow to the brain (perfusion, CTP) by undertaking a randomised trial. Extra scans are done in the same scanner and involve some extra radiation, injections of a contrast dye, and some extra time to acquire process and interpret. The extra scans may allow better treatment decisions for patients by increasing diagnostic certainty and by better assessment of stroke severity. However, we do not know whether the potential gains from better selection justify the resources and potential treatment delays that are involved. We will investigate whether the proportion of patients given clotbusting drugs differs between the two scanning protocols; and whether the outcomes differ, using standard measures of disability. We will also investigate whether use of different scanner manufacturers' software affect interpretation of scans.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of stroke eligible for IV rtPA according to current guidelines
* Informed consent
* Male or nonpregnant female ≥18 years of age
* Within 4.5 hours of onset as defined by time since last known well

Exclusion Criteria:

* Contraindications to thrombolytic drug treatment for stroke
* Pregnancy
* Known impaired renal function precluding contrast CT
* Known allergy to CT contrast agents
* Severe concurrent medical condition that would prevent participation in study procedures (e.g. cardiac failure with severe pulmonary oedema) or with life expectancy ≤ 3 months.
Peer Intervention for Social Skills (Brain Injury)

To investigate the effectiveness of a peer-led group intervention compared to a staff-led activity group to improve social communication skills for people with severe acquired brain injury (ABI).

An earlier pilot study tested the feasibility of the approach and the sensitivity of existing outcome measures to changes in group social interaction (NCT02211339). Following amendments to the pilot study protocol, twelve new participants with severe ABI were recruited from a residential post-acute rehabilitation centre. An experimental parallel group design was used to compare a peer-led group intervention to a staff-led social activity group. Participants were randomised to a peer-led intervention (n=6) or a staff-led social activity group (usual care) (n=6). The groups met twice a week for 8 weeks. A peer with severe ABI was trained separately to facilitate interaction the peer-led group. The training took place in 16 individual sessions over 4 weeks. Group behaviour was measured twice at baseline, after intervention and at maintenance (4 weeks) using measures meeting reliability, validity and responsiveness criteria tested in the pilot study.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of severe traumatic brain injury (TBI) or severe ABI with similar cognitive presentation to TBI
* Minimum of 6 months post injury
* Evidence of social communication impairment as a result of injury
* Ability to tolerate group activity

Exclusion Criteria:

* Significant aphasia
* Severe depression or psychiatric disorder
* Insufficient English to converse with peer
* Profound cognitive impairment
Amount of Droplet Formed During Percutaneous Dilatational Tracheostomy

During the percutaneous dilatational tracheostomy (PDT), large amount of droplets and aerosols are spread to the environment especially with the effect of ventilation during the dilatation phase. In such cases, it is recommended to take precautions such as masks and goggles or shields to protect practitioners from infection, however it has also been reported that droplets and aerosols can spread to the environment and can go far.

Flow controlled ventilation (FCV) with the use of Tritube® and Evone® could reduce droplet spread during PDT and provide a safer environment while operating on patients with infected airways.

During the percutaneous dilatational tracheostomy, large amount of droplets and aerosols are spread to the environment especially with the effect of ventilation during the dilatation phase. In such cases, it is recommended to take precautions such as masks and goggles or shields to protect practitioners from infection, however it has also been reported that droplets and aerosols can spread to the environment and can go far.

Flow controlled ventilation (FCV) with the use of Tritube® and Evone® could reduce droplet spread during PDT and provide a safer environment while operating on patients with infected airways.

SPSS 21.0 (Statistical Package for the Social Sciences) (Version 22.0, SPSS, Inc, Chicago, USA) program will be used for statistical analysis. After applying the Shapiro-wilk test for normality, the student's t test will be used if the distribution is not normal. Fisher's exact test or chi-square test will be used for categorical variables. Results p\<0.05 will be considered significant.

The investigators compared the amount of droplets scattered in the environment with PDT performed with FCV and conventional mechanical ventilation methods, with the ATP (adenosine triphosphate) bioluminescence method.

Eligibility Criteria:
Inclusion Criteria:

* percutaneous tracheostomy procedure

Exclusion Criteria:

* whose written consent cannot be obtained
* who undergo surgical tracheostomy for any reason
* patients with active infection in the area of the procedure
CIRculating CANcer MAster-Protocol

This exploratory study will focus on the development of the analyses of blood biomarkers to better understand the circulating biomarkers associated with cancer diagnosis, treatment efficacy and progressive disease


Eligibility Criteria:
Inclusion Criteria:

* Adult (\>18y)
* Owing a social security insurance
* Any solid cancer diagnosed by histopathology or cytology
* Patient with blood sampling required as per standard of care
* Informed consent signed

Exclusion Criteria:

* Refusal to participate
* No blood sampling required as per standard of care
* Hemoglobin \< 7g/dl (\< 9g/dl if respiratory or cardiovascular disease history)
* Heterologous blood transfusion in the last 48 hours
* Weight under 20 kg
A Clinical Trial Comparing Torcetrapib/Atorvastatin To Simvastatin In Subjects With High Cholesterol.

The Torcetrapib project was terminated on December 2, 2006 due to safety findings.

Cholesterol levels will be measured over six weeks in subjects being treated with two different kinds of cholesterol medications to see how the different treatments compare to one another.

For additional information please call: 1-800-718-1021

Eligibility Criteria:
Inclusion Criteria:

* eligible for statin treatment for LDL cholesterol by NCEP guidelines

Exclusion Criteria:

* Women who are pregnant or lactating, or planning to become pregnant.
* Subjects taking any drugs known to be associated with an increased risk of myositis in combination with HMG-CoA reductase inhibitors.
* Subjects with significant liver or kidney disease or significant heart failure.
The Acute Effects of Different Stretching Techniques

The flexibility of the hamstring muscles is very important and many stretching methods are applied on the hamstring muscles for reducing muscle resistance on movement. The objective of this study was to investigate the acute effects of static stretching and the Mulligan traction straight leg raise (TSLR) technique administered to the hamstring muscles on reducing its resistance to movement by using ultrasound elastography in healthy individuals.

The study will be included 22 healthy male volunteers. Static stretching will be administered to the hamstring muscles in the first group and the Mulligan TSLR technique will be administered on the same muscle in the second group. Active knee extension angles of the individuals will be evaluated by a digital goniometer and muscle elasticity will be assessed by ultrasound elastography.

Acute effects of Mulligan TSLR on reducing muscle resistance to movement will be evaluated by ultrasound elastography for the first time in this study. In our study, it was planned to examine the acute effects of static stretching and Mulligan TSLR techniques on reducing muscle resistance to movement by ultrasound elastography in healthy individuals with hamstring shortness.

Eligibility Criteria:
Inclusion Criteria:

* Participants with short hamstring muscles (active knee extension angle below 70 degree),
* Without knee, hip, ankle, or waist pathology,
* Who had not undergone any surgery on the lower extremity were included in the study.

Exclusion Criteria:

* Individuals with musculoskeletal, neurological, or vestibular problems,
* Bone pathologies,
* Joint laxity,
* Diabetes,
* Metabolic syndrome,
* Arthritic or inflammatory problems were excluded.
Effectiveness of Freedom Bed Compared to Manual Turning in Prevention of Pressure Injuries in Persons With Limited Mobility Due to Traumatic Brain Injury and/or Spinal Cord Injury.

Observational comparison on Incidence of Pressure Injury between the Freedom Bed Automated Continuous lateral Rotation Therapy System and Manual Caregiver Re-positioning every 2 hours on a standard Hospital Bed.

This study will include 8 vent dependent subjects with comparable diagnoses and nutritional levels. Of the subjects selected, 4 subjects will be placed on Freedom Beds and 4 will be placed on standard hospital beds for a period not less than 6 months. A waiver of informed consent is required prior to bed placement and data collection. Consented subjects will have primary and secondary diagnosis recorded, pressure mapping in supine 30-degree elevation, assessment of ventilator / oxygen support measured, oxygenation levels, nutrition levels, and estimated cardiac condition. Subjects will receive daily skin assessments and treatment as prescribed by the attending physician with weekly measurements and reporting of values. Subjects will continue until they reach one of the study endpoints: 1) discharge from the vent unit, or 2) withdrawal of informed consent, or 3) completion of the 6-month study.

Subjects placed on the Freedom Bed will be automatically turned in accordance with positions determined as optimal by initial pressure mapping and approved by the attending physician. All programmable turning angles, dwell times, head and leg elevations must be "dialed in" within a week of the study beginning. Any modification to the program during the study must be approved by the care team and documented accordingly.

Subjects placed on standard hospital bed will require manual re-positioning every 2 hours. All turning and/or re-positioning must be timed and documented.

Subjects who experience either development of pressure injuries, or worsening of their skin condition to the point a specialty bed is required will be deemed a test failure.

The primary and secondary outcome measures documented on each subject throughout the week will be collected by the Clinical Research Coordinator (CRC) on a weekly basis and submitted to the Principal Investigator. The weekly reports will then be consolidated by the CRC into a monthly report and submitted to the Institutional Review Board (IRB), Principal Investigators (PI) and Supervising Authorities (SA) for review.

Eligibility Criteria:
Inclusion Criteria:

Subjects or their legal representative able to provide written consent for study Must be rated between 6-12 on the Baden Scale Must be immobile and unable to preposition themselves. Must be within weight range of designated support surface.

Exclusion Criteria:

Subjects with unstable spinal fractures. Subjects with significant involuntary spasms. Subjects with severe scoliosis. A user must be able to lie in a partial back lying position.

Subjects considered morbidly obese.
The Incidence and Predictors of Developing Atrial Fibrillation in Patients With Inferior ST-segment Elevation Myocardial Infarction After Primary Percutaneous Coronary Intervention

Is to analyze the incidence and predictors of developing AF in patients with inferior infarction who undergo PCI with and without atrial and SN branches occlusion

Atrial fibrillation (AF) occurs in 5% to 18% of patient with acute ST-segment elevation myocardial infarctions (STEMIs) and 4.5% in patients with STEMI treated with percutaneous coronary intervention (PCI).

Diagnosis of AF in acute myocardial infarction (AMI) patients is important because it increases the risk of cardiovascular event and associated with increased in-hospital and long term rates . Atrial ischemia/infarction translates into P Q segment depression or elevation on the electrocardiogram and often associates with atrial tachyarrhythmias .

Side-branch obstruction is one of the adverse effects of PCI the location of the culprit vessel also affects the occurrence of AF in AMI Atrial arteries arise from the right coronary artery (RCA) and circumflex coronary artery (CX) and extend through the atrial myocardium to supply both chambers It is therefore conceivable that PCI of lesions located at the RCA and CX could lead to an accidental atrial branch occlusion .

Atrial myocardial ischemia secondary to atrial branches occlusion (ABO) might lead to mechanical atrial dysfunction, increased electrical vulnerability to atrial arrhythmias, and late structural remodeling .

The sino nodal (SN) artery originates from the proximal portion of the RCA in about 60% of humans Side branch occlusion of the SN artery occurring accidentally during PCI for proximal RCA lesions would provide an opportunity to produces SN dysfunction in humans. Uptill now , there have been no systematic studies concerning SN dysfunction caused by side-branch occlusion of the SN artery during PCI .

Left atrial volume seems to be a strong predictor of incident of AF , with increase in left atrial filling pressures, atrial stretch and enlargement of the chamber occur, leading to remodeling of the structure, physiologic properties, and electrical milieu of the left atrium, culminating in the development of AF

Eligibility Criteria:
Inclusion Criteria:

* Patients with inferior STEMI who will undergo PPCI (primary percutaneous coronary intervention )

Exclusion Criteria:

* -A history of preexisting AF
* Prior documentation of heart failure or reduced left ventricular ejection fraction \< 50%,
* Severe valvular disease ( rheumatic , sclerotic ) or secondary to AMI
* Left ventricular hypertrophy : enlargement and thickening of the walls of the ventricle
* Patients with inferior STEMI treated with intravenous thrombolysis or conservative strategy
* Patients with inferior STEMI who undergo primary PCI and associated with right ventricular or posterior infarction
* History of pulmonary embolism or COPD ( chronic obstructive pulmonary disease )
* Those with thyrotoxicosis
Health Focused Motivational Treatment for Alcohol Dependent Veterans

The purpose of this study is to determine whether a health focused motivational intervention will reduce alcohol use for dependent veterans who are receiving outpatient alcohol and drug treatment.

The early months of addiction treatment are a high risk time for relapse. The purpose of this study is to examine whether a health-related intervention delivered in an individual session with a therapist once per month in the initial 4 months of addiction treatment will reduce alcohol use among veterans already enrolled in weekly outpatient treatment group at the VA San Diego Healthcare System. In order to answer this question, study participants will be randomly assigned to one of three study conditions: 1) The Health Motivational condition that receives individual personalized health feedback and motivational activities, 2) the Health Education condition that receives individual education about health problems associated with the heavy alcohol use, and 3) the treatment as usual group that will receive no additional treatment. All participants will be assessed on a monthly basis for 4 months to evaluate alcohol use, drug use, and health status.

Eligibility Criteria:
Inclusion Criteria:

- Veterans receiving outpatient treatment at the VA San Diego Healthcare System Alcohol and Drug Treatment Program for a diagnosis of Alcohol Dependence

Exclusion Criteria:

* Diagnosis of Bipolar Disorder or Psychotic Disorder.
Comparison of Different Types of Surgery in Treating Patients With Early-stage Non-small Cell Lung Cancer

The purpose of this study is to compare early-stage peripheral non-small cell lung cancer lobectomy and sub-lobectomy surgery to evaluate if sub-lobectomy is as feasible and effective for the treatment of early-stage (diameter ≤2cm) peripheral non-small cell lung cancer as lobectomy.

Objectives:To establish a database of patients with early lung cancer surgery,and evaluate if sub-lobectomy surgery is as feasible and effective as lobectomy surgery in patients with early-stage peripheral non-small cell lung cancer,by assessing the retainability of lung function.and improvement of quality of life in those patients.

Outline:This is a prospective, matched, controlled, open, multi-center clinical study. Select the early-stage peripheral NSCLC 630 patients (diameter≤2cm), according to age and lesion type (GGO component ratio) two matching factor of 1: 2 assigned to sub-lobectomy group and lobectomy group.Patients are followed up every 3 months for the first year and then every 6 months for the other 4 years.

Eligibility Criteria:
Inclusion Criteria:

1. clinically diagnosed with stage I peripheral non-small cell lung cancer suitable for lobectomy.
2. T≤2cm，N0，M0.
3. aged 60 to 80 years old.
4. ECOG≤2.
5. according to the Ministry of Health, "with primary lung cancer diagnostic and treatment practices" (2011 edition) completed preoperative clinical staging examination.
6. voluntary participation, signed informed consent.

Exclusion Criteria:

1. pathologic stage is N1, N2, or M1a.
2. received postoperative adjuvant therapy (chemotherapy or targeted therapy).
3. radiotherapy or chemotherapy before surgery.
4. small cell lung cancer
5. benign lesions
6. patient unwilling to cooperate with surgery or observation.
Treating Children With Obstructive Sleep Apnea After Surgery Failure

The aim of this study is to evaluate the potential improvement of sleep quality in children who have residual obstructive sleep apnea, using either an orthodontic intervention or continuous positive airway pressure (CPAP), versus no treatment.

Consenting patients and their parents will choose one of three options (within the context of medical/craniofacial appropriateness): CPAP, orthodontic intervention, or to remain untreated (control). It would be ideal if each patient was randomly assigned to one of three groups. However, in our study, random allocation is not an option as the established clinical pathways for treatment, financial resources, and physiological presentation of the patient determines the appropriate intervention. In each group, the effectiveness of the intervention will be analyzed through the evaluation of sleep parameters, medical history, questionnaire responses, craniofacial characteristics, diet, and metabolomic markers, each at baseline and at 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with obstructive sleep apnea by polysomnography who presented with a failure in treatment with surgical removal of the tonsils and adenoid tissue --adenotonsillectomy (T\&A).
* Patients diagnosed with obstructive sleep apnea but for whom T\&A was not an option following assessment by Otolaryngology.

Exclusion Criteria:

* Autism spectrum
* Down syndrome
* Pulmonary hypertension
* Cystic fibrosis