cyrilzakka/clinical-trials huggingface dataset:
Individually Tailored and Integrated Social Support Network for Tobacco Cessation

This study will continue development of a quit smoking program delivered through text messaging. Upon completion of programming we will enroll 280 participants and randomize them to a control condition or the intervention condition. Assessments will occur at enrollment, and both 3 and 6 month follow ups.

This study builds on pilot work in which Live Inspired LLC and research partners developed T2Q (formerly "Text-2-Quit") a smoking cessation intervention delivered through text messaging. T2Q is a unique program with a number of features that provide superior support and service compared to existing text message quit smoking products. T2Q is 100% accessible through text messaging provides medication support for quitting smoking, an integrated social support network and live counseling. This phase II project will add functionality to accommodate use of multiple forms of quit smoking medications, and then conduct a rigorous test of the efficacy of T2Q among 280 adult smokers and examine smoking outcomes compared to controls at 3 and 6 months follow up. The study will also examine changes in smoking-related attitudes and behaviors among T2Q users to identify strengths and any potential weaknesses that may affect T2Q's impact on smoking outcomes. Analyses will examine the quality of social interactions within the T2Q integrated social support network and their role in promoting smoking abstinence. We will also conduct interviews with study participants in the T2Q arm to enable understanding of the user's experience with T2Q. Results of this trial will demonstrate the efficacy of T2Q - providing important credibility needed for successful commercialization. This research will also provide important data for possible enhancements to improve consumer appeal prior to commercialization.

This proposal finalizes development and testing of a unique, highly scalable intervention that can reach a U.S. market comprised of over 34 million adult smokers who use text messaging, and provide them with effective, evidence-based treatment. Text messaging enjoys near-market saturation and is a widely preferred method of communication with deep penetration across diverse groups. Wide availability of an attractive and effective smoking cessation program such as T2Q, may exert a powerful, sustained impact on public health

Eligibility Criteria:
Inclusion Criteria:

* age \>18
* current daily cigarette smoker
* use of text messaging at least once per week
* interested in quitting smoking within the next 30 days
* has access to a physician or healthcare provider
* no current drug/alcohol abuse.

Exclusion Criteria:

* Non-English Speaking
* Currently using quit-smoking medications or therapies
Myeloid to Adipocyte Transdifferentiation in Human Cells

In order to design new programs to help prevent weight gain, promote successful and sustainable weight loss, and help treat diseases related to obesity, the investigators need a better understanding of why accumulating fat in certain regions of the body is bad for health. It is known that not all fat cells are the same, but it was recently discovered that some fat cells may arise from stem cells that come from the bone marrow (bone marrow progenitors), a previously unrecognized origin. This discovery has been paradigm shifting, because dogma has long held that all white fat cells arise from fat tissue resident mesenchymal stem cells. This is also important because fat cells arising from the bone marrow lineage may be linked to worse health outcomes. The aim of this study is to determine if cells that were not previously believed to contribute to fat generation in humans are indeed capable of becoming fat cells. To answer this question the investigators will take samples of cells from the blood and the fat tissue of younger and older men and women, isolate the cells that came from the bone marrow and grow them in culture to determine if they will turn into fat cells. The results of this investigation may reveal potential mechanistic targets for future therapies to reduce the negative health outcomes associated with obesity related chronic diseases.


Eligibility Criteria:
Inclusion Criteria:

* Men and women age 21-40 y or 55-100 y;
* Older women will be postmenopausal who are at least 12 months past the final menstrual period (FMP);
* Young women will be premenopausal and eumenorrheic, not on hormonal contraceptive therapy;
* Body Mass Index (BMI) 22-35 kg/m2;
* Non-active to moderately active (vigorous exercise ≤ 3 days/wk lasting \< 30 min).

Exclusion Criteria:

* Immunosuppression therapy;
* On blood thinners, aspirin, or NSAIDs that cannot be withheld for the biopsy;
* Prior history of allergies to local anesthetics;
* Current use of hormones, or glucose lowering medication;
* Currently engaged in a vigorous exercise or diet program;
* Currently gaining or losing weight or using weight loss drugs;
* Type 2 diabetes (past/current diagnosis or treatment);
* Diagnosis of uncontrolled metabolic disorders (e.g., thyroid);
* History of severe obesity BMI ≥ 40 or significant weight loss (≥ 50 lbs);
* Postmenopausal - hormonal menopausal therapy use currently or in the previous 6 months;
* Premenopausal - irregular menstrual cycles defined as 2 or more missed cycles in the previous year, pregnant or planning to become pregnant during the study timeline (urine pregnancy test will be performed before DEXA \[dual energy x-ray absorptiometry\] scan is completed).
Praegnant Breast Cancer: Early/Advanced/Metastatic

Among patients with breast cancer the subgroup of patients with metastases are considered the group of patients with the worst prognosis. Not only regard-ing therapy decisions but also with regard to quality assured healthcare and health economics this entity of patients remains a challenge.

Recently, novel advances in breast cancer therapy aim at the targeted therapy of tumor entities and identification of patients, for whom the greatest therapy benefit, and the least side effects are expected.

However molecular assessment of the patient and the tumor in the metastatic situation is not performed on a routine basis and in many cases tumor character-istics from the primary tumor are considered reliable enough to make therapy decisions for the metastatic patients. Although molecular reassessment of tu-mor characteristics from tumor material of the metastasis is recommended in national guidelines, only a minority of patients is biopsied, because of the inva-siveness of the procedure, even though biopsy related complications are reported to be rare.

With modern analytic methods from blood based biomaterial there seems to be an opportunity to correlate blood based tumor assessments with actual charac-teristics of the tumor. These include expression analysis, tumor mutation analy-sis, tumor gene copy number aberrations and others. One of the main aims of the PRAEGNANT study is therefore to establish an infrastructure for the compre-hensive analysis of tumor and metastatic molecular characteristics of the patient and the tumor.

Furthermore, health care related outcomes as well as health economics provide novel approaches for integration of patients in study conduct and health care awareness and are study aims of the PRAEGNANT study.


Eligibility Criteria:
Inclusion Criteria for the early breast cancer setting:

* Adult breast cancer patients (age ≥18 years)
* Patients with breast cancer and no evidence of distant metastases with a diagnosis not longer than 91 days before study entry
* Patients, who are able and willing to sign the informed consent form

Inclusion Criteria for the advanced/metastatic setting:

* Adult women aged ≥18 years
* Patients with the diagnosis of invasive breast cancer (in German: Mammakarzinom, as op-posed to "non-invasive"= ductales Carcinoma in situ; irrespective of status of BC, e.g. TNM, re-ceptor status etc.) and
* Patients, who are willing and able to sign the informed consent form
* Patients with metastatic or locally advanced, inoperable disease proven by clinical measures (i.e. standard imaging)

Exclusion Criteria:

* Patients who did not sign the informed consent form
* Patients, who are not eligible for observation due to non-availability and/or severe comor-bidities as evaluated by the treating physician
A Social Media Personalized Normative Feedback Intervention for Heavy Drinking College Students

This study seeks to evaluate the unique and synergistic efficacy of social media-specific personalized normative feedback targeting the reduction of alcohol use among heavy-drinking college students who post alcohol-related content on social media.

Hypothesis: Alcohol personalized normative feedback, social media-specific personalized normative feedback, and the Alcohol personalized normative feedback+ social media-specific personalized normative feedback conditions will be more effective in reducing drinking than the attention control condition.


Eligibility Criteria:
Inclusion Criteria:

* College students recruited across three universities: Duquesne University, Miami University, and University of Houston (DU, MU, UH)
* Undergraduate college students 18 to 26 years old
* Meet heavy drinking (4+ drinks in one sitting for individuals assigned female at birth, 5+ drinks in one sitting for individuals assigned male at birth in the past month) and ARC (alcohol-related content) posting criteria (2+ ARC posts in the last 30 days for individuals assigned female at birth, 1+ for individuals assigned male at birth, on either Facebook, Instagram, Snapchat, Twitter, or TikTok)

Exclusion Criteria:

* Pregnant or of another protected population
Computerized-Adaptive Testing: Feasibility In Women With Pelvic Floor Disorders (CAT)

The objective of this pilot-study is to evaluate the feasibility and acceptability of PROMIS computerized-adaptive testing in women with urinary incontinence.

Patient-reported outcomes (PRO's) are important to assess treatment progress in the field of pelvic floor disorders (PFDs), including urinary incontinence, pelvic organ prolapse, and fecal incontinence. The NIH has invested in the Patient-Reported Outcomes Measurement System (PROMIS) to revolutionize PRO measures. To date, PROMIS instruments and feasibility and acceptability of PROMIS and Computerized-Adaptive Testing (CAT) technology has not been well explored in women with PFDs and warrant further investigation. In recruiting sixty women, the investigators will conduct pilot-testing on the CAT mode of the PROMIS questionnaires, and compare participant's attitudes about the paper short-forms versus the CAT modes of administration.

The investigators will recruit 60 women with UI to participate in this study. Participants will be asked to complete both paper and CAT versions of PROMIS questionnaires covering the physical, social and mental health domains (Appendix 1). The time it takes to complete each version will be recorded. After completing the questionnaires, all participants will be interviewed, which will include a brief "Usability and Satisfaction Questionnaire"(Appendix 2), questions about technical problems, preferences, and the acceptability of each mode.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Able to read English
* Diagnosis of urinary incontinence
* Age 18 or older

Exclusion Criteria:

* Unable to read English or cognitive limitations making it difficult for study participants to complete PROMIS questionnaires
Tryptase and Coronary Heart Disease

The main aim of this study will evaluate differences in serum levels of tryptase in study population. Will be selected a number of 350 patients hospitalized for coronary heart disease.

A series of scientific studies have evaluated the tryptase as a biomarker of coronary plaque instability, in the course of ischemic heart disease. Among these, the most recent and 'outcome' is better defined by Meixiang Xiang study, which has been conducted in 2011 on 270 patients. This study evaluated and compared the levels of tryptase in four populations:

1. acute myocardial infarction (31 subjects)
2. unstable angina (108 subjects)
3. stable angina (36 subjects)
4. coronary artery disease with coronary stenosis \<50% (95 subjects). In this Chinese population the final evaluations have led to define the tryptase as a marker independent of instability of the atheromatous plaque.

In reference to the fact that there is still some correlation between tryptase and coronary plaque instability and clinical symptoms, we propose a verification study of the role of tryptase as a biomarker in acute coronary conditions by studying a large population of Italian subjects in the acute phase of pathology and follow up.

The work will be conducted on 4 patient population:

1. acute coronary syndrome with ST elevation on electrocardiogram;
2. acute coronary syndrome without ST elevation on electrocardiogram (acute myocardial infarction with ST-segment depression on electrocardiogram and unstable angina)
3. noncritical coronary artery disease with coronary stenosis \<50%;
4. aortic aneurysms. Secondary endpoints will evaluate the role of tryptase in the event of major cardiovascular events.

Eligibility Criteria:
Inclusion Criteria:

* male and female subjects aged 18 to 80 years
* patients with clinical manifestations have been discovered and documented symptoms of coronary heart disease
* all patients with these characteristics will necessarily have to sign the informed consent for inclusion in the study

Exclusion Criteria:

* patients with allergy symptoms in place (hives, uncontrolled asthma) autoimmune diseases, mastocytosis, hypereosinophilia, myelodysplastic syndrome, cancer, kidney failure
* those who deny consent to participate
The Effect of Colchicine on Platelet Function Profiles in Patients With Stable Coronary Artery Disease

The effects of colchicine on cardiovascular health in patients with stable coronary artery disease have been shown to be beneficial due to its anti-inflammatory properties. This present study aims to explore the effects of colchicine on platelet reactivity in patients with coronary artery disease on dual antiplatelet therapy.

Recent landmark clinical trials on the use of colchicine in patients with chronic coronary artery disease has led to its implementation as an FDA approved drug for secondary prevention in patients with coronary artery disease. Colchicine exerts a range of anti inflammatory effects which plays a major role in reduction of atherosclerosis and prevention cardiovascular events. This current study aims to investigate the effect of colchicine on platelet reactivity in patients with stable coronary artery disease already on dual anticoagulants.

Eligibility Criteria:
Inclusion Criteria:

* Patients with stable coronary artery disease.
* Patients older than 18 years of age.
* Patients currently on dual anti platelets, aspirin and clopidogrel

Exclusion Criteria:

• Patients already on colchicine
Post Marketing Surveillance for PROSENSE™ a Cryotherapy Treatment of Renal Cell Carcinoma

This experiment is designed for post marketing data collection of a cryosurgical system \[PROSENSE™ of IceCure Medical\], for the treatment of renal cell carcinoma (RCC).

A post marketing data collection of a cryosurgical system \[PROSENSE™\] of IceCure Medical\], for the treatment of renal cell carcinoma (RCC).

Eligibility Criteria:
Inclusion Criteria:

1. Patient is above 18 years old.
2. The patient has enhanced solid mass of renal origin located in the kidney or elsewhere proved by imaging.
3. Patient's mass size is up to 5 cm at its largest dimension.
4. Patient is able to visit the clinic as needed during the 60-month follow-up period following the cryoablation procedure.
5. The patient has been informed of the study and agrees to its provisions, and has signed an IRB approved written informed consent, including data privacy authorization.

Exclusion Criteria:

1. Patients with permanent coagulation disorders or severe medical instability or active infection.
2. Patients with any terminal illness.
3. Patient participating in other trials using drugs or devices.
Effect of Resistance Training on Jump Landing Mechanics in Young Female Athletes

The purpose of this study is to determine if jump landing mechanics in young female athletes can be improved with a resistance training intervention.

After initial baseline testing, athletes were randomly selected to receive upper body (control group) or lower body (intervention group) resistance training. Athletes attended supervised training sessions twice per week for 12 weeks, after which they were re-tested.

Eligibility Criteria:
Inclusion Criteria:

* at least one year experience playing organized sports

Exclusion Criteria:

* previous experience with resistance training
* any injury with a pain level of more than 3/10 on VAS
* any health condition that would preclude them from completing the training or testing
* previous experience using a Biodex dynamometer
Feasibility of Bright Light Therapy on Fatigue, Sleep and Circadian Activity Rhythms in Lung Cancer Survivors

The purpose of this study is to determine the feasibility of a morning bright light therapy intervention for fatigue, sleep disturbances, and circadian activity rhythms in lung cancer survivors.

A randomized controlled trial to test the effects of morning bright light therapy on fatigue, sleep disturbances, and circadian activity rhythms in lung cancer survivors.

Eligibility Criteria:
Inclusion Criteria:

* Stage I-III Non-small cell lung cancer survivors
* Must be at \>6-weeks and \< 3 years post-surgical resection
* Must have diagnosis fatigue and/or sleep disturbances

Exclusion Criteria:

* Individuals clinically unstable.
* Mania, Bipolar disease or seizure disorder
* Macular degeneration or glaucoma.
* Currently receiving chemotherapy or radiation.
Congenital Cataract With Persistent Fetal Vasculature

To observe the clinical characteristics and surgical treatment of 24 cases of congenital cataract complicated with Persistent Fetal Vasculature (PFV) in 28 cases of congenital cataract in our hospital.

methods the clinical data of 28 eyes of 24 children with congenital cataract complicated with PFV who underwent surgical treatment in our hospital were analyzed retrospectively.

Eligibility Criteria:
Inclusion Criteria:

* congenital cataract with Persistent Fetal Vasculature

Exclusion Criteria:

* congenital cataract with no Persistent Fetal Vasculature
Treatment Prioritisation and Cost-Effectiveness Analysis for HBV Cure - Real-World Evidence from a Territory-Wide Cohort

A number of hepatitis B virus (HBV) cure regimens including antisense oligonucleotide (ASO) and small interfering RNA (siRNA) are under vigorous clinical development and the efficacy and safety will soon be available for regulatory approval. Patients most in need should be prioritised to receive HBV cure regimen to maximise its clinical benefits and speed up hepatitis elimination.

A territory-wide cohort study of all patients with chronic hepatitis B who have achieved functional cure of HBV. Real-world data will be used to estimate the risk of HCC, hepatic decompensation, and liver-related death for the subsequent simulation of HCC risk in particular populations of patients who achieved HBV cure. Literature search also be performed in parallel to cross-validate the estimates in untreated patients, and treated patients with incomplete or complete viral suppression with different stages of fibrosis based on existing literature. An optional systematic review and meta-analysis may be performed the address these issues.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with chronic hepatitis B, i.e. hepatitis B surface antigen (HBsAg) or HBV DNA positive for two times at least 6 months apart, AND
2. Patients achieved HBV cure, i.e. HBsAg turned negative
3. Aged 18 years old or above.

Exclusion Criteria:

1. Patients with missing age and gender
2. Serious medical illnesses or malignancy with life expectancy \&amp;lt;1 year
3. Age \&amp;lt; 18 years
Feasibility of a Self-Efficacy Ecological Momentary Intervention (EMA) App

This "SeApp" study aims to test a self-efficacy Ecological Momentary Intervention (EMI) in healthy students in the context of COVID-19. EMIs are mostly smartphone-based applications that deliver interventions to people while being engaged in their daily life activities. The app harnesses the power of self-efficacy autobiographical memories (e.g. problem-solving memories, memories of success).

Ecological Momentary Assessments (EMAs) are also incorporated into the study to capture individuals' feelings, affect, and behavior in real time.

This "SeApp" study aims to test a self-efficacy Ecological Momentary Intervention (EMI) in healthy students in the context of COVID-19. EMIs are mostly smartphone-based applications that deliver interventions to people while being engaged in their daily life activities. The app harnesses the power of self-efficacy autobiographical memories (e.g. problem-solving memories, memories of success).

Ecological Momentary Assessments (EMAs) are also incorporated into the study to capture individuals' feelings, affect, and behavior in real time.

Developed by psychologist Dr. Albert Bandura in 1977, the concept of self-efficacy refers to an individual's belief in their ability to perform the necessary actions to manage particular situations. Bandura's theory highlights four major components of self-efficacy, including mastery experiences, socialmodeling, social persuasion, and psychological responses. The app tested here focuses on mastery experiences, which are what individuals gain when they take on a challenge and succeed. The app prompts participants in the daily recall of self-efficacy memories. The project aims to test its feasibility and to investigate how daily self-efficacy and motivation can be enhanced and perceived stress reduced by daily memory-based training via smartphone app.

Eligibility Criteria:
Inclusion Criteria:

1. Value on Perceived Stress Scale ≥ 13
2. Student
3. Owner of a smartphone

Exclusion Criteria:

1. Psychiatric history

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