cyrilzakka/clinical-trials huggingface dataset:
Treating Chronic Insomnia in Breast Cancer Patients

This study is being conducted to evaluate the effectiveness of ramelteon 8mgs in the treatment of insomnia in patients that have completed their first chemotherapy treatment for breast cancer.

Phase IV, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy of ramelteon 8mgs in the treatment of insomnia in patients with breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* Female patients aged 21-60 years old
* Have a negative serum or urine pregnancy test for women of child-bearing potential
* Have a three-month or longer history of insomnia
* Self-report \< 6.5 hours of total sleep time, in addition to a sleep efficiency of less than 85%, averaged over two weeks of screening
* A score of less than 60 on the Zung Self-Rating Depression Scale
* Self-report bedtimes that do not vary by more than two hours on five nights per week
* Have completed chemotherapy for breast cancer less than two years prior to study drug administration
* Have completed chemotherapy for breast cancer for at least two months prior to screening visit
* Patients that are receiving Herceptin are eligible for study enrollment
* Have completed radiation therapy for breast cancer for at least two months prior to screening visit
* ECOG (Eastern Cooperative Oncology Group)score of 0-1
* Be able to read, understand, and provide written informed consent before enrolling in the study
* Must be willing to comply with all study visits and comply with daily phone calls to the IVRS throughout the study
* Agree to participate for the entire study period (about two months)

Exclusion Criteria:

* Metastatic disease
* Pregnant or lactating female
* Self-reports typical consumption of more than five alcoholic beverages on a single day or greater than 14 alcoholic beverages weekly
* Self-reports use of products containing nicotine of greater than 15 cigarettes daily or cannot avoid products containing nicotine during sleep periods
* Current use of any of the following medications, and cannot discontinue these medications for the duration of the study: Hypnotic medication, Anti-convulsants, Anxiolytics, Narcotic analgesics, Medications or supplements containing Melatonin, Ketaconazole and Fluconazole
* Currently taking fluvoxamine, brand name Luvox
* Have symptoms consistent with the diagnosis of any other sleep disorder other than insomnia (e.g. obstructive sleep apnea, narcolepsy, restless legs syndrome)
* Currently on night or rotating shift work
* Self-reports habitual napping of greater than one hour accumulated sleep on 4 or more days per week
* Has a psychiatric illness that interferes with normal sleep-wake function (e.g. major depression, post-traumatic stress disorder)
* A score of 60 or greater on the Zung Self-Rating Depression Scale
* Has current unstable medical disorder, such as symptomatic congestive heart failure, uncontrolled cardiac arrhythmia, or other serious medical condition as determined by the Investigator
Testing Strategies to Encourage Weight Loss in an Employer Setting

This is a 3-arm pilot randomized controlled trial to evaluate the effectiveness of two novel ways of structuring financial incentives to motivate and sustain long-term weight loss. The study will recruit eligible employees at Children's Hospital of Philadelphia (CHOP) to participate in a 6-month weight loss program and an additional 3-month follow-up period. The primary outcome measure in this randomized control trial will be pounds of weight lost between baseline and 6 months. The goal of this study is to evaluate whether a novel financial incentive program delivered through a workplace can effectively encourage sustained weight loss among obese employees.

The study hypotheses are 1) mean weight loss will be greater in all the intervention groups compared to the control group by the end of the 24-week intervention period; and 2) individuals in the intervention groups will have a lower mean weight at the end of the 12-week follow-up period than individuals in the control group.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 to 70 (inclusive)
* BMI between 30 and 40 (inclusive)

Exclusion Criteria:

* Inability to consent
* Illiteracy and/or inability to speak, read, and write English
* Participation in another research study
* Current treatment for drug or alcohol use
* Consumption of ≥ 5 alcoholic drinks per day
* Myocardial infarction or stroke within the past 6 months
* Current addiction to prescription medicines or street drugs
* Serious psychiatric diagnoses (e.g., severe major depressive disorder, bipolar disorder, schizophrenia)
* Pregnant or currently breastfeeding
* Diabetic and using any medicine besides metformin to control blood glucose
* Metastatic cancer
* Unstable medical conditions that would likely prevent the subject from completing the study
* Previous diagnosis of an eating disorder
* History of unsafe weight loss behaviors such as binging or the use of laxatives
Electronic Medical Record Alerts to Optimize Medical Therapy in Heart Failure and Reduced Ejection Fraction

OPTIMAL-HF is a pragmatic, cluster randomized, single-blind intervention trial that will be conducted at an outpatient clinic in Argentina. The trial will assess the effectiveness of an individualized-based alert system compared to usual care in improving GDMT optimization at 90 days in patients with HFrEF.


Eligibility Criteria:
Patients

Inclusion Criteria:

* Eligible patients will include those with an EF ≤ 40% on their most recent echocardiogram, age \> 18, and an outpatient cardiology encounter during the study period.
* Age 18 or over

Exclusion Criteria:

* under optimal medical treatment
* palliative care, or undergoing hemodialysis will be excluded

Cardiologist

Inclusion criteria:

Cardiologists from an outpatient clinic at a cardiovascular center in Buenos Aires will be selected for potential participation in the study.

Exclusion criteria Cardiologists belonging to the heart failure service
Molecular Breast Imaging (MBI) in Patients With Suspected Ductal Carcinoma in Situ (DCIS)

In this research study, the investigators are testing a new type of breast camera, called Molecular Breast Imaging, to see if it can find tumors in the subject's breast.

Patients who are suspected to have DCIS based on mammographic findings will be invited to participate in this study. The investigators plan to recruit 200 patients who are scheduled to undergo a breast biopsy for a breast lesion considered suggestive or highly suggestive of DCIS as determined by a radiologist specializing in breast imaging. Each patient will have a suspicious area of calcification on mammography of extent \< 3 cm, or a non-focal area of abnormality on ultrasound or MRI that is scheduled for evaluation by biopsy. Each patient will undergo an MBI study immediately prior to biopsy. The study coordinator will approach these patients and inform them of the research project. If they are interested in participating, informed consent will be obtained and the patient will be scheduled for the MBI study prior to the breast biopsy.

Eligibility Criteria:
Inclusion Criteria:

* Women with a breast lesion suspicious for DCIS who are scheduled for a stereotactic breast biopsy.
* Lesion must be considered suggestive or highly suggestive of malignancy according to the Breast Imaging Reporting and Data System Atlas criteria (BIRADS 4 or 5).
* Women between 25 and 90 years of age.

Exclusion Criteria:

* Unable to understand or sign a consent form.
* Pregnant or lactating.
* Physically unable to sit upright and still for 30-40 minutes.
A Study to Evaluate Safety and Immunogenicity of FluvalAB-like Influenza Vaccine in Non-Elderly Adult and Elderly Subjects

The purpose of this study is to determine the immunogenicity and tolerability of one 0.5 mL intramuscular (IM) injection of FLUVAL AB-like trivalent influenza vaccine containing 6μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens in adults and elderly people.


Eligibility Criteria:
Inclusion Criteria:

* male and female adult volunteers aged 18 years or older,
* mentally competent,
* able to understand and comply with all study requirements,
* willing and able to give written informed consent prior to initiation of study procedures,
* in good health (as determined by clinical judgement of the investigator on the basis of medical history and existing medical condition) or are in stable medical condition. Subjects will not be excluded with known, adequately treated, clinically significant organ or systemic diseases (e.g. asthma or diabetes), such that, in the opinion of the investigator, the significance of the disease will not compromise the subject's participation in the study.
* Female subjects aged 18 to 60 years (i.e. participants of childbearing potential) with a negative result from the urine pregnancy test prior to vaccination who agrees to use an acceptable contraception method or abstinence throughout the trial and not become pregnant for the duration of the study.
* Absence of existence of any exclusion criteria.

Exclusion Criteria:

* Pregnancy, breast-feeding or positive urine pregnancy test at baseline prior to vaccination. Female subjects who are able to bear children but not willing to use an acceptable contraception method for the duration of the study.
* Hypersensitivity to eggs, chicken protein, thiomersal, formaldehyde, gentamycin, ciprofloxacin, neomycin or any other component of the vaccine;
* History of anaphylactic shock or neurological symptoms or signs following administration of any vaccine;
* History of Guillain-Barré syndrome;
* Serious disease, such as cancer, autoimmune disease, advanced arteriosclerotic disease, complicated diabetes mellitus, acute or progressive hepatic disease, acute or progressive renal disease, congestive heart failure;
* Immunosuppressive therapy within the past 36 months;
* Concomitant corticosteroid therapy, including high-dose inhaled corticosteroids;
* Receipt of immunostimulants;
* Receipt of parenteral immunoglobulin, blood products and/or plasma derivates within the past 3 months;
* Suspected or known HIV, HBV or HCV infection;
* Acute disease and/or axillary temperature ≥37oC within the past 3 days;
* Vaccine therapy within the past 4 weeks;
* Influenza vaccination (any kind) within the past 6 months;
* Experimental drug therapy within the past 4 weeks;
* Concomitant participation in another clinical study;
* Any condition which, in the opinion of the investigator, may interfere with the evaluation of the study;
* Past or current psychiatric disease of the subject that upon judgement of the investigator may have effect on the objective decision-making of the subject;
* Alcohol or drug abuse of the subject.
AMH for the Identification of PCOM in PCOS Diagnosis

The purpose of this study is to validate the anti-müllerian hormone (AMH) cut-off established and validated in the APHRODITE study, for the determination of PCOM as part of the diagnosis of PCOS, using the Elecsys AMH Plus immunoassay.

The study participants will be women born July 1985-Dec 1987 in Northern Finland; the study partially links to the Northern Finland Birth Cohort 1986. Female subjects included in this cohort will be invited to participate in the study with the aim to enroll up to 1800 subjects. Each enrolled subject will have one study visit, where the clinical data required for assessing their PCOS status will be recorded, including a gynecological examination by transvaginal ultrasound to determine polycystic ovarian morphology (PCOM) status (antral follicle count and ovarian volume). Study subjects will also have blood drawn for serum collection, where hormonal parameters relevant for PCOS will be measured. The collected serum will also be used to measure the AMH levels using the Roche Elecsys AMH test.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Born July 1985-Dec 1987 in Northern Finland
* Signed informed consent regarding ROCHE collaboration

Exclusion Criteria:

* Unwilling to undergo gynecological examination including transvaginal ultrasound (TVUS)
* Unwilling to have blood drawn
* Pregnancy
Randomized Controlled Trial to Assess Efficacy of Melatonin for Children During Burn Rehabilitation

The specific aims of this investigation in children during burn rehabilitation include 1.) to determine the efficacy of melatonin intervention on improving sleep-related outcomes 2.) investigate the hypothesis that sleep inadequacy is associated with cognitive deficits and 3.) develop a new methodology specific for burn patients that accurately screens for the presence of intrinsic dyssomnia.


Eligibility Criteria:
Inclusion Criteria:

* History of burn injury
* Scheduled for an elective surgical procedure
* 5 - 22 years of age, inclusive

Exclusion Criteria:

* History of anoxic brain injury
* History of head injury within the last year
* Pre-existing seizure disorder
* Pre-existing neurological disorder
* Pre-existing blindness
* Known hypersensitivity to melatonin
* Anticoagulant use or aspirin therapy
* Antihypertensive medication use
* Diabetes mellitus or other endocrine disorders
* Autoimmune disorders
* Schizophrenia
* Inability to access internet
* Intellectual disability or inability to follow directions
Effect of Curcumin on Gut Microbiota in IBS

To evaluate the effect of curcumin food supplement on gut microbiota of children with irritable bowel syndrome (IBS) and to review any correlation between the changes in the microbiota with symptoms.

This is a prospective, placebo-controlled, double blinded, randomized control trial. This study will evaluate the effect of curcumin food supplement on gut microbiota of children with irritable bowel syndrome. Curcumin is a commonly used spice in Asian cooking and has a very good safety profile. Developing preparation of this compound for targeted delivery in the GI tract would provide a novel way to treat common FGID. This study will provide preliminary data for future studies to evaluate the role of gut microbiota in the pathophysiology of pain predominant FGID and how food supplements can be used to manipulate the microbiota.

Eligibility Criteria:
Inclusion Criteria:

* 10 to 18 years old
* Fulfill the Rome IV criteria for diarrhea predominant IBS
* English speaking
* Able to swallow curcumin/placebo capsules

Exclusion Criteria:

* Weigh less than 35 kg
* On any form of dietary restrictions
* Taken probiotics one month before enrollment
* Antibiotic treatment one month before enrollment
* IBD
* Celiac disease
* Peptic ulcer disease
* H. Pylori gastritis
* Abnormality of gastrointestinal tract
* Previous abnormal endoscope
* Previous abdominal surgeries
* Gall stones
* Biliary tract obstructions
* Liver pathologies
* Liver failure
* Active GI infection
* Positive stool cultures
* Drug or alcohol abuse
* Concomitant immunological/hematological/neoplastic/heart/ renal/pulmonary condition
* Any other medical condition or taking any form of drug(s) which can explain the current symptoms
* Take oral or intravenous drugs which could have potential drug interaction with curcumin
* Lactating or pregnant or planning to become pregnant
* Developmental delay
* Parents that are developmentally delayed
* Have a diet high in curcumin/turmeric
Protecting the Eyes of Gamers With Lubricating Eyedrops

The excessive use of screens particularly amongst digital gamers can adversely impact the health of the surface of the eyes with symptoms and signs of surface damage. While strategies including limiting screen time exist, these may be ineffective given the widespread rise of digital device use and gaming culture in the modern era. There is limited evidence for the protective effect of lubricating eyedrops on the ocular surface for handheld console and computer gamers.

The aim of this study is to investigate the protective effect of a lubricating eyedrop (TheaLoz Duo) on the surface of the eyes in handheld console and computer gamers. The main question it aims to answer is whether TheaLoz Duo could protect the surface of the eyes from dessication and alleviate symptoms of dry eye disease in handheld console and computer gamers.

Participants will receive either the lubricating eyedrop first for 1 month, followed by a control condition (no eyedrops) for another month, or the other way round. Participants will attend 3 visits in total, each separated by 1 month apart. During each visit, routine clinical assessments of the front of the eye will be conducted. Subsequent findings from this timely study will help improve care of the surface of the eyes for a growing population of gamers worldwide.

This study will be a randomized, outcome assessor-masked, cross-over clinical study to assess the potential impact of TheaLoz Duo lubricating eyedrop on symptoms and signs of dry eye disease in handheld console and computer gamers. All visits will be conducted at the Aston Dry Eye Clinic in Aston University, Birmingham, United Kingdom.

Eligibility Criteria:
Inclusion criteria:

* Individuals with dryness symptoms as assessed with the Ocular Surface Disease Index (OSDI score ≥ 13).
* Individuals who play handheld console and computer-based games ≥ 2 hours everyday on average
* Individuals who are comfortable and competent at using smartphone applications
* Age ≥ 18 years, male or female
* Able to provide written consent in English
* Able to instil the treatment lubricating eyedrop on their own, and return any provided eyedrop bottle to the researcher used at the end of the treatment
* Able to attend multiple visits (3 visits over 2 months)

Exclusion criteria:

* Pregnancy
* Use of any topical ocular medical eyedrops or lubricants in the 1 week prior to starting the study or during the study period. Those who are using existing lubricating eyedrops and are interested in participating will be required to stop their lubricating eyedrops for 1 week prior to commencing the study
* History of ocular surgery, trauma or infections in the past 6 months
Individual and Dyadic Functioning, Adherence, and Quality of Life After Kidney Transplantation

Following solid organ transplantation, adherence to treatment regime (especially with regard to a reliable intake of immunosuppressant medication) is crucial for transplant survival, and has an impact on the patients' health and morbidity. Approximately 35 % of graft rejection or failure cases in kidney transplant patients are due to insufficient levels of adherence or non-adherence to immunosuppressant medication. Adherence is influenced by both individual and interpersonal aspects in complex interaction.

This study aims at investigating individual and dyadic functioning of both patients and their spouses following kidney transplantation. Outcome measures of interest are patient's level of adherence and both patient and spouse's subjective quality of life.

In Germany, kidney transplant patients form the largest group in solid organ transplantation. Improvements in diagnosing and treating medical problems and complications have lead to enhanced survival rates after transplantation. A crucial factor for the long-term success of kidney transplantations is the patients' life-long adherence to immunosuppressant medication. Numerous aspects influencing adherence have been investigated empirically. Across studies, social support has been shown to have an important impact on levels of patients' adherence to treatment. In kidney patients, lower levels of social support have been found to be a risk factor for non-adherence to immunosuppressant therapy, and impaired integration of the transplantation.

From other long-term and potentially life-threatening medical conditions such as breast cancer, the patients' husbands/wives, or spouses are often the primary source of (social) support and of central importance with regard to treatment-related decisions. Thus, spouses are important agents in the course of treatment but are also under considerable (additional) strain. Most studies on psychosocial outcomes of organ transplantation have focused on either patients or spouses. However, medical, social, and psychological aspects influence transplantation outcomes and patients' as well as spouses functioning in complex interaction and should be investigated accordingly.

The study at hand aims at investigating the nature of marital / relationship quality and communication, social support behaviors, emotional arousal, and psychological distress in patients and their spouses after kidney transplantation. Additionally, the role of these variables of interest for important post-transplantation outcomes such as the patients' adherence to immunosuppressive medication and quality of life in both patients and spouses will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* kidney transplantation six or more months ago
* treated with immunosuppressive medication
* no Episode of acute rejection reported
* in a Long-term relationship (Duration of 12 or more months)
* spouse accompanying Patient to transplantation outpatient clinic

Exclusion Criteria:

* none
COPD in the Time of COVID-19

This cross-sectional observational study will collect information about changes in exacerbation frequency and behaviour amongst a clinical cohort of severe or complex COPD clinic patients. This will be done through a combination of telephone survey and access to electronic heath records.

This study will be a cross-sectional observational study utilising a telephone survey.

After obtaining informed verbal consent participants will be asked to recall their symptoms, exacerbation events and exacerbation medication usage over the periods of 01/03/20 - 14/03/20 (pre-lockdown) and then 15/03/20 to 30/04/20 (lockdown).

A structured survey will follow on from this asking questions regarding behaviour including self-isolation, shielding, other household contacts, visitors to the home, arrangements for shopping, changes in smoking behaviour (including that of other smokers in the household), medication changes, self-reported change in use of preventer medication, self-reported change in walking/activity levels and self-reported changes in anxiety levels.

Baseline clinical data will subsequently also be collected from the comprehensive respiratory review previously performed in the complex COPD clinic (comprising both hospital and GP records.) This will include previous AECOPD phenotyping (eosinophil levels, sputum culture and viral PCR), previous lung function testing, prescribed medication, BMI and smoking status and history. Previous AECOPD events will be counted and graded based on GP antibiotic or steroid prescriptions and hospital admissions.

Participants will be contacted once as part of the main study following verbal informed consent (via telephone). This will be a brief survey as described above, lasting approximately 20 minutes. A second similar survey will take place up to 12 months after the initial contact to evaluate longitudinal changes associated with the lockdown (further details on this will be submitted as an amendment at a later date due the shifting and unpredictable nature of the COVID-19 pandemic and lockdown, this will be prior to initiating these second calls).

Additional clinical data will be collected from healthcare records to quantify disease severity. Participant postcodes will be collected to link results with changes in local air pollution as recorded or estimated during the COVID-19 lockdown.

Eligibility Criteria:
Inclusion Criteria:

1. Confirmed clinical diagnosis of COPD
2. Ability to provide informed verbal consent via English language telephone consultation
3. Adults aged over 40 years

Exclusion Criteria:

1. Patients currently admitted to hospital
2. Unwilling/unable to provide informed consent