cyrilzakka/clinical-trials huggingface dataset:
Smoking Reduction and Cessation Interventions for Chinese

This study aims at developing and testing a stage-based scheduled smoking intervention that targets to encourage smokers to reduce smoking and to facilitate smoking abstinence. We hypothesize that smokers who receive the staged-based scheduled smoking intervention will be more likely to report smoking abstinence, quit attempts, and smoking reduction at 12 months.

The objective of the study is to document and systematically investigate the use of smoking reduction and cessation strategies targeting Chinese American smokers at various level of readiness to quit smoking.

Using a randomized controlled study design, the experimental intervention will be compared to a control group that will receive the expert system intervention only at 3-, 6- and 12-month follow-up. The primary aim is to test the following hypotheses:

1. Participants receiving the experimental intervention will be more likely to achieve at least a 50% reduction from baseline at 3-month (end of treatment), 6- and 12-month follow-up than participants in the control condition.
2. Participants receiving the experimental intervention will be more likely to report a 24- hour quit attempt at 3-, 6- and 12-month follow-up.
3. Participants receiving the experimental intervention will be report a longer length of abstinence in their quit attempts at 3-, 6- and 12-month follow-up.
4. The experimental condition will yield a higher rate of smoking abstinence at 3-, 6- and 12-month follow-up.

The secondary aim is to examine the feasibility of the proposed intervention which will be assessed by recruitment efficiency, refusal rates, adherence, usage, safety data, and perceived helpfulness of the intervention components. In addition, analyses will be pursued to explore both short- and long-term maintenance of smoking reduction achieved, the association between smoking reduction and changes in self-efficacy of resisting from smoking, stage movements (changes in readiness for quitting), and the use of coping strategies for smoking at follow-ups. The study will provide important empirical data for developing effective smoking cessation strategies that are culturally and linguistically appropriate for the Chinese American population.

Eligibility Criteria:
Inclusion Criteria:

* Self-identified ethnic Chinese men and women
* 18 years or older
* report smoking cigarettes daily with at least 5 cigarettes per day in the last 7 days
* reside in California
* be able to read written English or Chinese

Exclusion Criteria:

* Currently engaging in assisted smoking cessation efforts
* Have health conditions that have contraindications of using nicotine replacement treatment (NRT) such as pregnancy, within 6 months post MI, severe or unstable angina
Clinical Safety and Preliminary Efficacy of AAV-DC-CTL Treatment in Stage IV Gastric Cancer

The purpose of this study is to evaluate the clinical safety and preliminary efficacy of antigen-specific cytotoxic T lymphocytes induced by dendritic cells infected by recombinant adeno-associated virus with CEA gene in the treatment of stage IV gastric cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Sex: male or female
* Age: from 18 to 80 years
* Histology: gastric cancer
* Clinical stage: stage IV
* Karnofsky performance status: more than 50%
* Expected survival: more than 2 months
* Sex: male or female
* Laboratory tests results 7 days before the start of treatment:

  * White blood cells: more than 3.0 × 109/L
  * Platelets: more than 100 × 109/L
  * Neutrophils: more than 1.5 × 109/L
  * Hemoglobin: more than 80g/L
  * Serum glutamate pyruvate transaminase: less than 2.5 folds of the upper normal limit (ULN)
  * Serum glutamic-oxal (o) acetic transaminase: less than 2.5 × ULN
  * Serum bilirubin: less than 1.25 × ULN
  * Serum creatinine: less than 1.25 × ULN
* Pregnancy test: the test of women of child-bearing period must be negative 7 days before the start of treatment
* Contraception: male and female subjects of child-bearing period must adopt a reliable method of contraception before entry into this study until 30 days after stopping this study
* Informed consent: subject must have the ability to understand and voluntarily sign a written informed consent

Exclusion Criteria:

* History of neoplasms: other neoplasms
* Medical history: mental disease, or congestive heart failure, or severe coronary artery disease, or cardiac arrhythmias, or concomitant corticosteroid therapy
* Metastasis: clinical symptoms of brain metastasis
* Other clinical trial: the subject received other clinical trial before this study
* Laboratory tests: the serum test of human immunodeficiency virus, or hepatitis B virus, or hepatitis C virus was positive
* Woman: pregnant or lactating women
* Compliance: poor compliance
COX-2 Inhibitor Study In Patients With Rheumatoid Arthritis

This study is being conducted to find out if an investigational drug called GW406381 can help people with rheumatoid arthritis.


Eligibility Criteria:
Inclusion criteria:

* Rheumatoid arthritis (RA) for at least 12 months.
* Required a non-steroidal anti-inflammatory drug (NSAID) or COX-2 inhibitor for RA for at least 5 out of 7 days of each week for the 4 weeks prior to screening.

Exclusion criteria:

* Any history of cardiovascular disease (e.g., heart attack, stroke, congestive heart failure, uncontrolled high blood pressure), documented peripheral arterial insufficiency and symptomatic, clinically significant claudication, or who have a history of peripheral arterial embolism.
* Have an active stomach ulcer or history of any stomach tear or bleeding.
Talk Therapy After Stroke

Strokes are the first cause of acquired physical disability among adults. Some studies proved that depression is often an unrecognized complication from stroke, associated with a vital prognosis, functional and cognitive pejorative diagnosis. It led us to pose the hypothesis of the existence of a particular psychological state after stroke particularly favorable to a psychotherapeutic alliance. So, this longitudinal monocentric study aims to estimate the feasibility of a talk therapy and its impact on the anxio-depressive symptomatology after stroke.


Eligibility Criteria:
Inclusion Criteria:

* ischemic or aemoragic stroke minor 1 week, confirmed by cerebral imaging

Exclusion Criteria:

* severe aphasia (NIHSS criteria 9: sup or egal: 2)
* Chronic psychiatric preexistant desease.
Abdominal Trunk Function After Surgical Repair of Abdominal Rectus Muscle Diastasis

There is insufficient evidence regarding the benefit from surgical reconstruction of post-partum abdominal rectus muscle diastasis. The purpose of this study is to evaluate the abdominal trunk function preoperatively and postoperatively in a group of women undergoing surgery for abdominal rectus muscle diastasis.

There is little evidence regarding the various treatment options of abdominal rectus muscle diastasis in post-partum women. The lack of evidence may, to a great extent, be explained by the lack of uniform criteria for assessing the trunk function and how the trunk function affects the ability to perform daily activities. To be able to evaluate the condition with symptomatic ARD a more comprehensive, multimodal instrument is therefore needed.

In collaboration with the surgical clinic and the physiotherapy clinic at Södersjukhuset a multimodal examination test was developed with the purpose to be able to evaluate the full picture of the condition.

The purpose of this study was to evaluate the effect of surgical reconstruction of post-partum abdominal rectus muscle diastasis in women with insufficient improvement after adequate physical training using a novel multimodal evaluation tool.

Eligibility Criteria:
Inclusion Criteria:

* Non-smoking women
* BMI \<35
* Inter-recti distance \>3cm
* Lack of response to standardized core stabilizing training
* \>1 year since last partus
* No intention of further pregnancies

Exclusion Criteria:

* Inability to quit smoking
* BMI \>35
* Inter-recti distance \<3cm
* \<1 year since last partus
* Further pregnancies not excluded
Discovery of Novel Biomarkers of Dietary Exposure in the EPIC Calibration Study

This proposal aims at identifying new biomarkers of dietary exposure using metabolomic approaches. This project is based on the European Prospective Investigation on Cancer and Nutrition (EPIC) Calibration Study and more particularly upon a subset of 494 men and women from 4 European countries (Germany, Greece, Italy and France). Urine and blood samples are analyzed by untargeted metabolomics.

Subjects participating in the study are characterized by the availability of one 24-hr urine sample, blood serum, 24-hr dietary recall (24HDR) and food frequency questionnaire (FFQ) data.

The main objectives of the proposal are:

1. To collect a set of high-quality metabolomic data containing rich information on the food-derived metabolome.
2. To mine this data in different Metabolome-Wide Association Studies in order to identify food-derived metabolites discriminating consumers and non-consumers of various foods, nutrients and dietary patterns.
3. To identify the food-derived metabolites characteristic of the consumption of the different foods/nutrients and dietary patterns.

Eligibility Criteria:
Inclusion criteria:

* Aged 30-70
* Healthy
* Residing within Europe.
* Have donated one 24-hr urine sample, blood serum.
* Have filled one 24-hr dietary recall (24HDR) and food frequency questionnaire (FFQ).

Exclusion criteria:

* 24-hr urine sample and 24-hr dietary recall not collected on a same day.
* Incomplete collection of 24-hr urine sample.
Microbiome Changes in Severe Burns

The purpose of the study is characterizing changes in the microbiome of severely-injured adult patients as they progress through stages of injury, reconstruction, and recovery from burns.

There exists a vast collection of bacteria that live on, and within, each human body. All surfaces exposed to the external environment, such as the nares, mouth, airway, skin, and intestines, are colonized, and it is estimated that over 100 trillion microbes live within the gastrointestinal tract alone. The interactions between these colonizers and their host have been demonstrated to affect myriad aspects of human health from autism and inflammatory bowel disease to cancer therapy response. Investigations into the role of the intestinal microbiome in sepsis have been ongoing for decades. Data has shown that critically ill patients can not only experience increased intestinal permeability - a factor that allows for the translocation of bacteria and non-microbial tissue injurious factors into the, primarily lymphatic, circulation, but also a disruption of the symbiotic relationship to one of dysbiosis, resulting in what is known as a "pathobiome."

That the microbiome is affected by thermal injury should be no surprise; burn injury has been shown to drive significant intestinal ischemia and inflammation with subsequently increased intestinal permeability. , Burn-induced lung injury has been linked to these changes, and alterations in the microbiome between critically-burned patients (when compared with healthy controls) have been demonstrated, with resultant overgrowth of gram-negative anaerobes. Thus, the microbiome has a clear role in affecting the clinical course of thermally-injured patients.

This is a descriptive case series study examining microbiome changes in two adult patients admitted with severe burn injuries. This will be done by obtaining regular stool samples and analyzing the microbial content, as well as obtaining clinical data on patients including those factors likely to influence the microbial content.

Eligibility Criteria:
Inclusion Criteria:

* sustained greater than or equal to 20% body surface area of the body (BSAB)

Exclusion Criteria:

* pre-existing clinical infections
* historical evidence of gastrointestinal disease such as Ulcerative Colitis
* Crohn's disease
* Celiac disease
* historical evidence of gastrointestinal Clostridium difficile infection
* no anti-biotic use for 3 months prior to admission
* AIDS
* immune suppressing medications or metastasized cancer
* peritonitis
* non English-speaking
Exercise Echocardiography on LV Mechanics in Patients With CAD: a Speckle-tracking Echocardiography

Recovering blood flow to a coronary stenosis may improve left ventricular (LV) function in patients with coronary artery disease (CAD). However, the reported data about evaluation of LV function post-percutaneous coronary intervention (PCI) in CAD was limited. The aim of this study was to compare the LV function measured by 3 min low dose exercise stress echocardiography (ESE) combined 2D speckle tracking echocardiography (STE) in patients with CAD underwent PCI, and to identify factors affecting the change of LV function. Patients with CAD who underwent acute PCI were enrolled.

The assessment of temporal changes in systolic and diastolic regional left ventricle function by 2D-STE after successful reperfusion therapy of acute myocardial infarction (AMI).The estimated total number of participants is 90 patients with AMI and treated with successful percutaneous coronary intervention were included in this study. The echocardiographic measurements were performed in all patients within in-hotpital after PCI procedure, and then followed up at 7, 14, 30, 60 and 180 days after discharge. Recovery of regional systolic and diastolic myocardial function after acute myocardial infarction evaluated by ESE-STE.

Eligibility Criteria:
Inclusion Criteria:

* acute myocardial infarction diagnosed by a physician
* undergoing percutaneous coronary intervention
* Exercise testing and stress echocardiography are performed with the approval of the physician.

Exclusion Criteria:

* Severe cardiac valve disease
* Left bundle branch block
* Uncontrolled diabetes or hypertension
* Orthopedics or other conditions that hinder from exercise
* Uncontrolled sinus tachycardia (greater than 120 beats per minute)
Fexofenadine As Adjuvant Therapy in Parkinson Disease

Parkinson's disease (PD) is a chronic, progressive neurological disorder characterized by both motor and non-motor symptoms. PD is the second most common neurodegenerative disorder after Alzheimer's disease and the most common movement disorder. PD has age-related pathology; it is present in 1-2% of the population over 60 years of age. The disease is characterized by a triad of disordered voluntary motor activity in the form of bradykinesia (slowness of movement) or even akinesia (absence of movement),rigidity and postural instability, and a resting tremor of the hands and less commonly the feet.


Eligibility Criteria:
Inclusion Criteria:• Age ≥ 50 years. Both male and female will be included. Patients with Parkinson's disease on dopamine replacement therapy. Modified Hoehn and Yahr stage, MHY 1-4

Exclusion Criteria:• Atypical parkinsonism or drug-induced parkinsonism Breast feeding Pregnant women and women with planned pregnancy. Patients with significant liver and kidney function abnormalities. History/presence of acute heart disease Alcohol and / or drug abusers. Patients with known allergy to the study medications Other medical conditions that can interfere with results or endanger the participant.
Perioperative Analgesia for Knee Arthroplasty (PAKA)

Peri-articular knee infiltration with Levobupivicaine 150mg, Morphine 10mg and Ketorolac 30mg reduces postoperative pain following primary total knee replacement compared with the current standard treatment of femoral nerve blockade.


Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing an elective primary unilateral total knee arthroplasty (TKA) under the care of an orthopaedic consultant at University Hospitals Coventry and Warwickshire NHS trust are potentially eligible for the trial.

Exclusion Criteria:

* Those with sufficient cognitive impairment that they would be unable complete questionnaire (cognitive impairment).
* Those patients who lack capacity under the Mental Capacity Act 2005
* Those patients with a pre-operative history of neurological abnormality in the ipsilateral leg e.g. history of stroke, neurogenic pain or previous nerve injury.
* Those patients having spinal anaesthesia.
* Those patients with a specific contraindication to the analgesic agents used:Morphine: Hypersensitivity reaction Ketorolac: Active or previous peptic ulcer. History of upper gastrointestinal bleeding or perforation, related to previous NSAID therapy.
* Haemorrhagic diatheses, including coagulation disorders
* Hypersensitivity to ketorolac trometamol or other NSAIDs
* Moderate or severe renal impairment (serum creatinine \> 160 micromol/l)
* Levobupivicaine: Levobupivacaine solutions are contra-indicated in patients with a known hypersensitivity to levobupivacaine, local anaesthetics of the amide type or any of the excipients
* Uncontrolled angina
* 2nd/ 3rd degree heart block
Atrial Deganglionation as a Therapy for Cardiac Surgery Patients With Atrial Fibrillation

A prospective single-arm study of ganglionated plexi ablation in cardiothoracic surgery patients with a history of atrial fibrillation.

This study assesses the use of electroporation/pulsed field ablation (PFA) to selectively ablate ganglionated plexi in cardiothoracic surgery patients with atrial fibrillation. The PFA treatment will be performed in up to 12 patients with a history of paroxysmal atrial fibrillation. The primary end point will be recurrence of atrial fibrillation out to 1 year follow-ups.

Eligibility Criteria:
Inclusion Criteria:

* Age is between 18 and 70 years.
* Scheduled for open-chest cardiothoracic surgery, for coronary artery bypass grafting and/or aortic valve repair/replacement
* Have a documented medical history of paroxysmal or early-stage persistent atrial fibrillation within the previous 12 months.
* Legally competent and willing to sign the informed consent.
* Life expectancy of at least 2 years.

Exclusion Criteria:

* Previous cardiac surgery
* Prior pericardial interventions
* Prior endocardial or epicardial pulmonary vein isolation (PVI), or any other invasive AF therapy
* Previous or existing pericarditis
* Use of amiodarone within the previous 12 months.
* Long-standing persistent atrial fibrillation
* Indication for mitral or tricuspid valve surgery
* Indication for concomitant left atrial appendage (LAA) ligation or excision
* History of previous radiation therapy on the thorax
* History of previous thoracotomy.
* Prior electrical or mechanical isolation of the Left Atrial Appendage (LAA)
* The presence of LAA occlusion devices, coronary stents, prosthetic heart valves, pacemakers or implantable cardioverter defibrillators (ICDs)
* Myocardial infarction within the previous 2 months
* New York Heart Association (NYHA) Class IV heart failure symptoms
* Left Ventricular Ejection Fraction (LVEF) \< 40%, measured by transthoracic echocardiography (TTE)
* Left atrial diameter \> 5.0 cm, measured by transthoracic echocardiography (TTE)
* The presence of left atrial thrombus when examined by transesophageal echocardiography (TEE)
* The presence of atrial fibrillation (AF) attributable to non-cardiovascular causes such as thyroid disease, electrolyte imbalance/dehydration or other reversible causes
* Active infection or sepsis as evidenced by increased white blood cell count, elevated C-reactive protein (CRP) or temperature \> 38.5°C
* Known or documented carotid stenosis \> 80%
* Stroke or transient ischemic attack within the previous 6 months
* Known or documented epilepsy
* Pregnancy or child-bearing potential without adequate contraception
* Circumstances that prevent follow-ups
* Drug abuse
* Patients cannot be enrolled in another clinical study
Fast Track Rehabilitation Following Video-assisted Lung Segmentectomy

Aim of this prospective randomized study is to assess the safety and efficacy of video-assisted lung segmentectomy (Group B) comparing with mini muscle-sparing thoracotomy (group A) during diagnostic process for pulmonary nodules.


Eligibility Criteria:
Inclusion Criteria:

* Patients with undiagnosed multiple pulmonary nodules

Exclusion Criteria:

* Centrally located lesions
* previous thoracotomy
* extensive lung consolidation, and inability to achieve one lung ventilation
HeartBeet Clinic Pilot Trial

The goal of the current study is to conduct a pilot randomized controlled trial comparing the HeartBeet Clinic, a 16-week lifestyle medicine program with virtual, small-group coaching, to a self-paced, online education program. In this pilot study, the primary goals will be to assess acceptability and feasibility of the study and intervention procedures to prepare for a larger efficacy trial.

Individuals randomized to the 16-week HeartBeet Clinic lifestyle medicine intervention will complete two in-person group visits, one at the beginning and one at the end of the program. They will also attend group coaching sessions that will be held virtually, using an online coaching platform that will house the self-paced course, intervention materials, and schedule for the coaching and live events. Individuals in this group will be asked to attend 12 group coaching sessions with a health coach, 6 skills sessions to enhance behavior change skills with a health coach, and 6 deep dives with subject matter experts. These sessions will require 1-2 hours of participation per week. In addition, participants will be asked to work through the self-paced course and workbook activities on their own between sessions.

Individuals randomized to the self-paced education group will have access to the virtual coaching platform for the self-paced course and workbook. They will receive email reminders to work through the workbook activities. They will not have contact with the study clinician or health coach except to troubleshoot technical issues.

Eligibility Criteria:
Inclusion Criteria:

* Have at least one cardiovascular risk factor, including: a) high cholesterol, as defined as diagnosis of hyperlipidemia and/or most recent total cholesterol \> 200 or b) hypertension (as defined by a diagnosis of hypertension and/or active antihypertensive medication prescription) and/or BMI \> 27
* Identify as a HealthPartners patient, including having an outpatient encounter with a HealthPartners or Park Nicollet clinician in the prior year
* Be willing to pay for copays/charges for group medical visit and labs drawn as part of usual care if not fully covered by insurance
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Willingness to maintain current doses of statin, anti-obesity medication, and/or antihypertensive medication during the study
* Willingness and ability to attend weekly group coaching sessions for 16 weeks at ≥ 1 scheduled group coaching time
* Access to necessary resources for participating in a technology-based intervention (i.e., computer, smartphone, internet access

Exclusion Criteria:

* Concurrent participation in another treatment or intervention study
* History of coronary artery, cerebrovascular or peripheral arterial disease including myocardial infarction, unstable angina, revascularization, stroke/TIA, carotid intervention, claudication, or congestive heart failure
* Existing diagnosis of dementia and/or other cognitive impairment that would be a barrier to participation