cyrilzakka/clinical-trials huggingface dataset:
Effect of Spironolactone in the Prevention of Anthracycline-induced Cardiotoxicity (SPIROTOX)

The goal of this clinical trial is to evaluate the effect of spironolactone in the primary prevention of cardiotoxicity in cancer patients who are undergoing chemotherapy with anthracycline within 12 months. The main question it aims to answer is:

• Does spironolactone reduce the incidence of cardiotoxicity in patients undergoing anthracycline chemotherapy?

Participants will:

* Be cancer patients over 18 years starting treatment with anthracycline;
* Be randomized to receive either spironolactone or a placebo for 1 year;
* Undergo assessments of their left ventricular ejection fraction (LVEF), global longitudinal strain, and cardiac biomarkers over the 12-month period.

Researchers will compare the spironolactone group to the placebo group to see if cardiotoxicity incidence differs between the two.

Objective:

To assess the potential of spironolactone in preventing anthracycline-induced cardiotoxicity among cancer patients.

Background:

There's ongoing debate and a dearth of evidence regarding the role of mineralocorticoid receptor antagonists, such as spironolactone, in averting anthracycline-induced cardiotoxicity.

Study Design:

A randomized, double-blind, placebo-controlled trial conducted at a single center.

Sample Size:

264 patients.

Intervention:

Eligible participants will be randomized on a 1:1 basis to either receive spironolactone or a placebo over a 12-month period.

Primary Outcome:

Incidence of cardiotoxicity at the 12-month mark.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with cancer indicated for anthracycline chemotherapy treatment
* Age 18 and above
* Signed informed consent form

Exclusion Criteria:

* Previous use of anthracycline.
* Hypersensitivity to any mineralocorticoid receptor antagonists
* Symptoms of heart failure (exertional dyspnea, orthopnea, nocturnal paroxysmal dyspnea, and pulmonary or systemic congestion)
* Left ventricular ejection fraction (LVEF) \< 45%
* Previous diagnosis of cardiomyopathy, coronary artery disease, or moderate to severe mitral or aortic disease
* Renal insufficiency defined as an estimated glomerular filtration rate \< 30 ml/min/m2
* Hyperkalemia, defined as serum potassium ≥ 5.0 mmol/L
* Chronic liver disease, defined aspartate aminotransferase (AST) or alanine aminotransferase (ALT) values more than 3 times the upper limit of normal
* Current participation in another study
Efficacy of a Web App With Multimedia Animations to Teach Therapeutic Exercise in Shoulder Pain

The aim of this trial is to develop and evaluate a web app to teach patients about how to correctly perform a tailored program of shoulder exercises.

The exercise program will be evidence based, and there will be two groups in the study, both exercising. The follow up will be of 6 months.

The web app will consist of 3D multimedia animations (video and audio) which the patient will be able to access from any device with internet connection (cell phone included).

The trial will include patients with shoulder pain because of rotator cuff tendinopathy.

The investigators will carry on a pilot study with 100 patients randomly distributed into two groups, with 6 months follow up. Both groups will perform the same treatment, but the control group won´t use the exercise app. There will be four dependent variables: correct exercise performance, compliance degree, satisfaction with the treatment and expectations to improve with treatment. As secondary dependent variables will be analyzed pain (at rest, with movement and at night), functional disability (SPADI questionnaire), and patient´s assessment of app video characteristics (usability, utility and satisfaction) and co-interventions.

Eligibility Criteria:
Inclusion Criteria:

* Older than 18 with uni or bilateral shoulder region pain
* Being able to read and write in Spanish
* Pain for at least 3 months
* Pain intensity (in rest, activity and/or at night) of at least 3/10
* Two positive clinical sings at least from: Neer sign, Hawkins-Kennedy sign, empty can or pain arc
* Must have and use at least 3 times/week email of their own and a device with internet connection

Exclusion Criteria:

* Polyarticular or generalized pain
* Cognitive impairment
* Cancer
* Serious neurological disease
* Other shoulder pain causes
* History of main trauma
* Sings or symptoms of cervical pain (excluding upper trapezius) or cervical radiculopathy
* Apprehension sing, sulcus sing
* Passive movement limitation (but final degree in horizontal abduction or extension)
* Tendon rupture in ultrasound
* Glenohumeral arthritis in plain radiographs or calcium bigger than 5mm
Comparative Effectiveness of Microprocessor Controlled and Carbon Fiber Prosthetic Feet in Transtibial Amputees

The purpose of this research is to evaluate benefits of a microprocessor controlled prosthetic ankle-foot device compared to a non-microprocessor controlled or passive carbon fiber prosthetic ankle-foot device.

Recent advancements in microprocessor controlled prosthetic ankle-foot systems have allowed additional functionality for the lower limb amputee, but research into the effectiveness of microprocessor controlled ankle-foot systems has been limited.

In this research study, differences in perceived mobility, functional capabilities and gait parameters between energy storing and returning and microprocessor controlled ankle-foot mechanisms will be identified where they exist. Also a comparison of the initial function with a new system compared to the function after a four week accommodation period will provide insight into the time it takes for the prosthesis user to experience a benefit from a microprocessor ankle-foot.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral transtibial amputation
* Age 18-99 years old
* Body weight below 275 lbs
* Non-pregnant
* English speaking
* Current user of prosthesis for at least one year
* Wear time 8 hrs/day or more
* MFCL ≥ K-3
* Well-fitting and functioning prosthesis
* No use of ambulatory aide
* Able to tolerate testing protocol
* Able to walk on slopes
* Must, in the opinion of the investigator, be willing and able to complete all aspects of the study, adhere to the study visit schedule and comply with the assessments

Exclusion Criteria:

* Amputation level other than unilateral transtibial
* Age \<18 or \>99 years old
* Body weight above 275 lbs
* Pregnant
* Non-English speaking
* Not current user of prosthesis
* Less than one year use of prosthesis
* Wear time less than 8 hr/day
* MFCL \<K3
* Poor fitting and functioning prosthesis
* Indicating that the socket fit is painful, or unacceptable
* Use of ambulatory aide
* Unable to tolerate testing protocol
* Unable to walk on slopes
* Presence or history of any condition that, in the view of the investigator, places the participant at high risk of poor treatment compliance or of not completing the study
* Any neurologic impairments known to cause gait and/or balance dysfunction
Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease

To evaluate the efficacy of batoclimab 680 milligrams (mg) subcutaneous (SC) once a week (QW) for 12 weeks followed by 340 mg SC QW for 12 weeks versus placebo on proptosis responder rate at Week 24.


Eligibility Criteria:
Inclusion criteria:

* Are ≥18 years of age at screening.
* Have a clinical diagnosis of TED associated with active, moderate to severe TED with the following at screening and Visit 0:

  * A CAS ≥ 4 in either eye, and
  * Clinical evidence of worsened proptosis with:

    1. Proptosis ≥ 18 mm and/or
    2. Proptosis ≥ 3 mm increase from participant's baseline (prior to diagnosis of TED), as estimated by the Investigator/assessor
* Have moderate to severe active TED, as defined by European Group on Graves' Orbitopathy (EUGOGO) guidelines.
* Have onset of active TED within 12 months prior to screening.
* Have documented evidence of detectable anti-TSHR-Ab at screening.
* Are not expected to require immediate surgical intervention and are not planning corrective surgery/irradiation or medical therapy for TED during the course of the study.
* Are euthyroid with the baseline disease under control or have mild hypo- or hyperthyroidism.

Additional inclusion criteria are defined in the protocol.

Exclusion criteria:

* Have decreased best corrected visual acuity due to optic neuropathy.
* Have at least a 2-point decrease in CAS or ≥2 mm decrease in proptosis between screening and Baseline assessments in either eye.
* Have used any steroid (intravenous or oral) for the treatment of TED or other conditions within 4 weeks prior to screening.
* Have used any steroid (Intravenous or oral) with a cumulative dose equivalent to ≥ 1 g of methylprednisolone for the treatment of TED.
* Have known autoimmune disease other than TED, that, in the opinion of the Investigator, would interfere with the course and conduct of the study.
* Had previous orbital irradiation or surgery for TED.

Additional exclusion criteria are defined in the protocol.
Identifying Molecular Determinants of Infertility in Men (MODIFY)

The purpose of this study is to understand the underlying mechanisms of infertility caused by unknown factors. The investigator propose to identify small non-coding RNA (sncRNA) biomarkers of infertility and advance towards developing a more accurate and robust approach for infertility diagnosis.

The goal of the study is to identify small non-coding RNA signatures of infertility in men through the comparison of sperm sncRNA profiles from around 100 men (21-50 years of age). The participants will be classified into fertile and infertile groups by the conventional method.

Through the project, the investigator intends to understand the underlying mechanisms of idiopathic infertility. By utilizing semen as liquid biopsy, through sperm sncRNA profiling and comparison (infertile vs fertile). The investigator proposes to identify the sncRNA (miRNAs, piRNAs and tRFs) as biomarkers of infertility.

The investigator proposes to generate a validated signature of sncRNAs that will help in selecting high quality sperms for IVF.

Eligibility Criteria:
Inclusion Criteria

* Male, aged 21 - 50 years old
* Proficient in English language
* Willing to comply to study protocol
* Able to provide written informed consent

Exclusion Criteria

* Current and/or previous diagnosis of Tuberculosis, Acquired immunodeficiency syndrome (AIDs), and other sexually transmitted diseases
* Experiencing severely limited mobility (eg. Wheelchair bound, need walking aid)
* Diagnosed with severe unstable mental conditions (eg. Dementia, or cognitive impairment)
* Alcohol or drug abuse
HAART Adherence Among HIV-infected Persons and the Factors Affecting Treatment Adherence

The general objective of this study is to evaluate HAART adherence in Estonia and the factors affecting adherence; and the impact of an individual adherence enhancement counselling and treatment monitoring model (Advanced Adherence, AdvAdh), compared to the regular counselling received by HAART patients.

Specific HIV treatment - HAART (Highly Active Antiretroviral Therapy) can suppress HIV replication and consequently preserve the functioning of immune system. HAART therapy is a lifelong treatment with several different concomitantly administered oral medications. According to studies, low adherence to treatment is directly related to patient's knowledge and beliefs about HAART.

Studies have shown the success of different interventions increasing adherence to HAART, but additional studies need to be carried out in order to determine the most effective components of the interventions and the methods most suitable considering the local context, that could be used in everyday work and with limited resources.

The first places to implement the activities directed at improving treatment adherence are medical institutions, i.e. the departments of infectious diseases where HIV-positive individuals receive HAART treatment.

The aims of the study are:

* to determine the rate of adherence to HAART and its associated factors;
* to conduct a small-scale intervention (randomised controlled) study implementing a brief adherence counseling targeting persons receiving HAART.

Eligibility Criteria:
Inclusion Criteria:

* HIV infected;
* ≥18 years of age;
* speak and read either Estonian or Russian;
* receiving or starting a HAART regimen

Exclusion Criteria:

- triple class antiretroviral drug resistance, as determined from a prior resistance test performed in clinical practice, defined according to International Antiviral Society - USA (IAS-USA) interpretive guidelines for genotypic resistance mutations
A Prospective & Retrospective Study on Ectopic Lymphoid-like Structures in Chronic Skins of Autoimmune Bullous Diseases

The purpose of this study is to identify the presence or absence of ectopic lymph node-like structures in skin lesions of patients with autoimmune bullous disease and the subtypes of the cells deposited there. In addition, this study clarifies the therapeutic effect of intralesional steroid injection in patients with pemphigus harboring ectopic lymph node-like structure.


Eligibility Criteria:
Inclusion Criteria:

\<Presence of Ectopic Lymphoid-like Structures in the Skin lesion of Autoimmune Bullous Disease Patients\>

Prospective study Inclusion Criteria:

1. Adults over 19
2. Patietns who voluntarily signed the consent form
3. Patients who are diagnosed with autoimmune bullous disease through clinical, histological and serological tests

Retrospective study Inclusion Criteria:

1. Samples in human-derived banks from March 2013 to October 2018
2. Patients who are diagnosed with autoimmune bullous disease through clinical, histological and serological tests
3. Adults over 19 \<Treatment of Ectopic Lymphoid-like Structures in the Skin lesion of Autoimmune Bullous Disease Patients\>

Prospective study Inclusion Criteria:

1. Adults over 19
2. Patients who voluntarily signed the consent form
3. Patients who have skin lesions harboring ectopic lymph node-like structure in a prospective or retrospective manner
4. Patients who have chronic lesions sustained for more than 4 months during the treatment of systemic corticosteroids

Retrospective study Inclusion Criteria:

1. Patients who have skin lesions harboring ectopic lymph node-like structure in a retrospective manner
2. Paitents who have been treated for intralesional steroid injection
3. Patients who have data of photography to compare the clinical effects before and after intralesional corticosteroid treatment.

Exclusion Criteria:

1. Patients who do not meet the criteria for autoimmune bullous disease
Transgender and Gender Diverse Individuals Screening for Breast Cancer

The goal of this multicentric prospective study is to evaluate the incidence of Breast Cancer in transgender and gender-diverse population.

In recent years, the scientific community has been paying increasing attention to lesbian, gay, bisexual, transgender, queer, intersexual, asexual population, with a special focus on transgender and gender-diverse individuals. Globally, the percentage of adults who identify themselves as transgender varies between 0.3% and 0.5%, while approximately 0.5% to 4.5% of adults are estimated to identify as gender-diverse. Despite the growing visibility of transgender and gender-diverse community and the efforts towards their depathologization, healthcare still needs to address two fundamental issues: the inadequate preparation of healthcare staff regarding gender incongruence which results in mistreatment and discrimination and the lack of uniform and large-scale prospective data. Scientific evidence regarding the risk of developing breast cancer (BC) in these patients and the related benefits of BC screening are still limited and insufficient. The Associazione Italiana di Oncologia Medica (AIOM), reported that the risk of developing BC tends to increase in transgender women compared to cisgender men (standardized incidence ratio \[SIR\], 46.7; 95% CI, 27.2-75.4), although it does not reach the level of risk in cisgender women (SIR, 0.3; 95% CI, 0.2-0.4). Conversely, in transgender men, the risk of BC decreases when compared to cisgender women (SIR, 0.2; 95% CI, 0.1-0.5), but it still remains higher than the risk present in cisgender men (58.9; 95% CI, 18.7-142.2).As for the screening programs, there is a lower adherence among the transgender and non-conforming-gender population compared to the cisgender population, due to socio-economic barriers and a lack of clear recommendations supported by scientific evidence.The National Comprehensive Cancer Network (NCCN)and AIOM guidelines currently do not include specific recommendations for transgender individuals due to the aforementioned lack of scientific evidence.

The American College of Radiology (ACR) regulates screening protocols for the transgender population based on factors such as age, hormone therapy exposure, surgical history, and risk categories.

Eligibility Criteria:
Inclusion Criteria:

* Transgender and gender-diverse individuals ≥18 years old who meet the ACR inclusion criteria
* Signed Informed Consent

Exclusion Criteria:

* Refuse to sign Informed Consent
Way to Quit - Comparative Efficacy, Acceptance and Effectiveness of Health Incentive Structures

Using the NIH-funded Way to Health platform, the investigators will conduct this smoking cessation randomized controlled trial (RCT) among CVS employees. The investigators will be able to determine the comparative and absolute efficacy and effectiveness of 4 different incentive structures that are each grounded in behavioral economic principles. Additionally, the investigators will measure rates of and reasons for acceptance of each incentive structure, and examine participant characteristics that modify the efficacy and acceptance of different incentive structures.

Specific Aim I: Compare the efficacy and effectiveness of 4 financial incentive structures for improving "quit rates" (rates of prolonged smoking abstinence for 6 months): (a) individual financial rewards, (b) individual deposit contracts, (c) cooperative rewards, and (d) competitive deposit contracts

H1: Compared with usual care, all 4 incentive structures will increase quit rates significantly.

H2: Compared with individual financial rewards of equivalent size and schedule, individual deposit contracts, cooperative rewards, and competitive contracts will each increase quit rates significantly.

H3: Group-oriented structures will increase quit rates significantly more than individual-oriented structures.

Specific Aim II: Compare smokers' acceptance of these 4 financial incentive structures for smoking cessation

H4: Uptake rates of reward-based structures will be higher than of structures involving deposit contracts.

H5: Uptake rates of group-oriented structures will be higher than of individual-oriented structures.

Specific Aim III: Identify individual characteristics that modify incentive structures' efficacy and acceptance

H6: Incentives will promote relatively greater quit rates among participants with fewer substitute reinforcers.

H7: Incentives will promote relatively greater quit rates among participants with lower incomes.

H8: Higher-income persons will be relatively more likely to accept incentives requiring deposit contracts.

Eligibility Criteria:
Inclusion Criteria:

* Active smoker of 5 cigarettes per day for at least 6 months;
* At least 18 years old;
* Current full- or part-time employee of CVS or be a family member or friend of a current full- or part-time employee of CVS.

Exclusion Criteria:

* Use a form of tobacco other than cigarettes while participating in the study (as this may influence biochemical testing);
* Are unable or unwilling to access the internet;
* Are unable to provide informed consent.
* Due to the web-based nature of this study, people without reliable computer and internet access will also be excluded.
Multi-modal Imaging of Myofascial Pain

The goal of this study is to develop new imaging biomarkers for quantitative assessments of myofascial pain.

This study aims to develop a multi-modal, multi-parametric, multi-scale imaging of the human myofascial unit by combining magnetic resonance imaging (MRI), surface electromyography (sEMG), and fiber-optic imaging and sensing.

Participants (half with active neck/shoulder/back pain, and half healthy controls) will be recruited from pain management clinics and Volunteer for Health, or will be referred by Dr. Xioabin Yi. They will undergo all three imaging techniques and complete a number of patient questionnaires over the course of a single study visit. The study team will then identify candidate biomarkers capable of differentiating between healthy (no myofascial pain) and those with active pain to target in a future clinical trial.

Eligibility Criteria:
Healthy Volunteer Inclusion Criteria:

1. Absence of a history of chronic pain in the targeted anatomical location (i.e., neck and shoulder) that had limited activities of daily living or work
2. A numerical current pain index of lower than 0.5 according to initial assessment with visual analog scale
3. Able to understand the goal of the project and give informed consent.

Healthy Volunteer Exclusion Criteria:

1. Pregnancy or breastfeeding
2. Contraindication to MRI
3. Previous severe/acute neck or shoulder injury
4. Previous neck or shoulder surgery
5. Neck or shoulder deformities
6. Inability to provide consent.

Myofascial Pain Patient Inclusion Criteria:

1. Between the ages of 18 and 80 years old
2. Neck and/or shoulder pain, unilateral or bilateral
3. Duration of symptoms for longer than 4 weeks
4. Pain scale at the active state higher than 4 according to initial assessment with visual analog scale
5. Presence of active trigger point(s) according to palpation and/or presence of taut band

Myofascial Pain Patient Exclusion Criteria:

1. Recent history of trauma to the neck (e.g., whiplash)
2. Acute cervical radiculopathy
3. Acute cervical spine pain component or acute cervical spinal pathology Presence of neuromuscular pathologies or inflammatory muscle diseases (e.g., dermatomyositis)
4. Systemic disease with diffuse body pain (e.g., system lupus erythematosus and and thyroid disease)
5. Peripheral neuropathy
6. Cancer-related pain
7. Pregnancy, coagulopathy, fever, general/local infection at the pain site, substance abuse, peripheral neuropathy, or any other diseases that may account for signs and symptoms mimicking myofascial pain
8. Contraindication to MRI.
Iodine Nutrition During Pregnancy and Related Neonatal Physical Development

Recent studies have found, in both developed and developing countries, there is still a considerable number of pregnant women in iodine deficiency status.Our overall aim is to monitor iodine status of pregnant women in China, and to examine the correlation between maternal urine iodine concentration (UIC) and newborn physical development level.

Background: Recent studies have found, in both developed and developing countries, there is still a considerable number of pregnant women in iodine deficiency status. Our overall aim is to monitor iodine status of pregnant women in China, and to examine the correlation between maternal urine iodine concentration (UIC) and newborn physical development level.

Design: prospective cohort study

Methods: During August - December 2015,250 participants(28-32 weeks' gestation) were selected to participate in the study.The investigators collect the spot urine samples(n=750) once every two weeks.

Setting: Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine.

Participants: 150 normal pregnant women and 100 pregnant women with gestational diabetes (28-32 weeks' gestation) and their newborns were selected to participate the study.

Eligibility Criteria:
Inclusion Criteria:

* 22-35 years,
* 28-32 weeks' gestation,

Exclusion Criteria:

* a known history of thyroid disease in the non-pregnant state and previous.