cyrilzakka/clinical-trials huggingface dataset:
Cardiovascular Function in Cancer Survivors

The aim of the current project is to understand the effect of dietary nitrates (via beet-root juice), on its ability to improve parameters of cardiovascular health in cancer survivors with a history of anthracycline chemotherapy.

Cancer remains one of the leading causes of death in modern society, but due in part to increasing rates of detection coupled with advanced therapies, of the ≈230,000 people newly diagnosed with breast cancer each year, approximately 90% are expected to live beyond 5 years. Despite the trend in improved cancer-related mortality, breast cancer survivors are at a significantly increased risk for cardiovascular disease (CVD) morbidity and mortality. As such the American Heart Association has recently highlighted the immediate need to evaluate changes in cardiovascular health and function in the early stages of cancer treatment.

The mechanisms of adjuvant therapies on cardiovascular function may be the result of increased generation of reactive oxygen species (ROS) and altered redox status, specifically the balance between nitric oxide and superoxide. As such, nitrate supplementation has been shown to attenuate Doxorubicin (chemotherapy drug)-induced ventricular function in animal models. These data implicate dietary nitrates as one potential therapeutic intervention that could be used to improve cardiovascular health in cancer survivors.

Beetroot juice (BRJ) is a nutritional supplement that has been studied to examine potential effects of dietary nitrates affecting vasodilation. The increased nitrate levels have been implicated in helping increase nitric oxide bioavailability, which have been shown to improve cardiovascular function in older adults and those with known cardiovascular disease. The question, however, of whether or not BRJ will enhance cardiovascular function in breast cancer survivors is yet to be determined.

The primary aim of the current investigation is to test the hypothesis that dietary nitrate supplementation, via beet-root juice, improves parameters of cardiovascular health in cancer survivors with a history of anthracycline chemotherapy treatment.

Eligibility Criteria:
Inclusion Criteria:

* cancer survivors (at least 1 year post treatment)
* Prior administration of anthracycline chemotherapy
* partial/complete remission

Exclusion Criteria:

* Unable to provide informed consent
* Kidney disease
* High risk of kidney stones
* Diagnosed hemochromatosis
* Pregnant, breast feeding, or planning to become pregnant
* Non-English speaking
Blood Glycan Biomarkers in Women With Stage IV Breast Cancer

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur and identify biomarkers related to cancer.

PURPOSE: This research study is looking at blood glycan biomarkers in women with stage IV breast cancer.

OBJECTIVES:

* To profile serum glycan biomarkers in women with metastatic stage IV breast cancer, healthy controls, and patients with noncancer medical illness.
* To determine whether serial serum glycan biomarkers correlate with response of metastatic disease to treatment.

OUTLINE: This is a multicenter study.

Blood is collected from patients with metastatic breast cancer, patients with noncancerous illness, and healthy volunteers. Samples are analyzed for serum glycan biomarkers by matrix-assisted laser desorption/ionization (MALDI) and Fourier transform ion-cyclotron resonance mass spectrometry (FT ICR MS) methods.

Blood samples are collected every 3 months for up to 18 months from patients with metastatic breast cancer. Patients without cancer have a single sample collected.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Patient or participant at the Women's Health Clinic, the Internal Medicine Clinic, or at the UC Davis Cancer Center, meeting 1 of the following criteria:

  * Diagnosis of stage IV metastatic breast cancer, receiving active treatment with chemotherapy, endocrine therapy, or targeted therapy
  * Patients/participants without cancer

    * Healthy control being seen for annual exams, meeting the following criteria:

      * No chronic disease
      * Not on regular prescribed medications
    * Patient without cancer being seen in the Internal Medicine Clinic
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Menopausal status not specified
* Not pregnant or breast feeding
* No other active cancer

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
International Registry of Intra-arterial and Endosaccular Flow Diverters (IRF)

This multicenter retrospective cohort study aims to evaluate and compare the technical performance, safety, and clinical outcomes of intracranial aneurysms treated with flow diverter stents and endosaccular flow disruptors.

Flow diverters and endosaccular flow disruptors used for the treatment of intracranial aneurysms exhibit distinct procedural and clinical outcomes, with potential differences in device-specific parameters such as procedure time, radiation exposure, adjunct device requirements, and long-term angiographic success. Since the completion of the Pipeline Embolization Device (PED) for the Intracranial Treatment of Aneurysms trial, the field of flow diversion has undergone continuous evolution with the development and approval of several devices. While these devices share a similar mechanism for aneurysm occlusion, their design and delivery systems can vary significantly. Various studies have demonstrated a promising safety and efficacy profile; however, the available data for a direct comparison of the technical and clinical outcomes between these devices remains limited.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (18 years of age or older)
* Underwent endovascular treatment with one of the following devices:

  a. Flow Diverter Stents: i. Pipeline Flex (Covidien, California, USA) ii. Pipeline Flex with Shield Technology (Covidien) iii. Surpass Streamline (Stryker Neurovascular, California, USA) iv. Surpass Evolve (Stryker) v. Silk flow diverter (Balt Extrusion, Montmorency, France) vi. Flow-Redirection Intraluminal Device (FRED; MicroVention) vii. Flow-Redirection Intraluminal Device X (FRED X; MicroVention) viii. p64 Flow Modulation Device (phenox GmbH).

  b. Endosaccular Flow Disruptors: i. Woven EndoBridge (WEB; MicroVention) ii. Luna/Artisse System (Medtronic) iii. Medina Embolic Device (Medtronic) iv. Contour Neurovascular System (Cerus Endovascular) v. Neqstent Coil Assisted Flow Diverter (Cerus Endovascular) vi. pCONus and pCANvas (phenox GmbH) vii. Nexus Aneurysm Embolization System (EndoStream Medical) viii. CITADEL™ Embolization Device (Balt, USA)
* Complete medical records and follow-up data available

Exclusion Criteria:

* Incomplete procedural or follow-up records
* Non-flow-diverter or non-flow-disruptor treatments (e.g., coiling-only cases)
* Aneurysms treated with investigational devices not listed within Inclusion Criteria
SMS Reminders and Treatment Compliance and Efficacy in Patients With FGIDs

The effect of SMS follow-up on drug compliance and efficacy in patients with FGIDs has not been reported in the literature. We, therefore, conducted a prospective randomized controlled trial to investigate whether SMS follow-up could improve treatment adherence in patients with FGIDs, which in turn would help symptom relief and improve treatment outcomes.

The irritable bowel syndrome (IBS) and other functional gastrointestinal disorders (FGIDs) are common and pose significant burdens to patients. Although regular medications have substantial benefits for disease remission, many patients do not follow the recommendations of standard medication regimens given by physicians at the time of the visit, so how to improve patient compliance becomes even more important. Many factors can affect drug compliance. Forgetting seems to be one of the important reasons for poor compliance. In order to solve this problem, many studies such as drug charts/calendars, mini kits, etc. have been conducted in previous studies. At present, with the popularization of mobile phones, SMS-based interventions are gradually being applied to various medical environments. Compared with the phone, SMS consumes less time and can be easily integrated into the patient's daily life. Therefore, short messages may be more suitable for follow-up of patients outside hospital.

Eligibility Criteria:
Inclusion Criteria:

* Patients with newly diagnosed FGIDs according to Rome-IV
* Aged 18-70 years
* With no obvious organic abnormalities

Exclusion Criteria:

* With organic gastrointestinal diseases
* With psychiatric diseases or are taking psychotropic agents
* With severe cardiopulmonary or other organ diseases
* Pregnant women
Intervention With Black Currant Seed Press Residues in Healthy Subjects

The study was performed to investigate the effects of the consumption of black currant seed press residues, which were baked into bread.

Berry seeds are a by-product of berry fabrication (e. g. to juices or jam). In order to maintain their functionality and long life span, berry seeds need to contain cell stabilizing ingredients such as vitamins and polyphenols. Since it seems to be a valuable source of health beneficial substances in human nutrition, commercial use should be found. Therefore, seeds were pressed (seed press residue), ground and baked into bread for consumption.

Black currant seed press residues are rich in tocopherols and also contain anthocyanins; both act as antioxidants. Additionally there is 50% fibre in the residue, soluble and insoluble fibre in equal shares.

Eligibility Criteria:
Inclusion Criteria:

* discrimination between smoker (\> 5 cigarets/d) or non-smoker

Exclusion Criteria:

* diet during the study
* serious sport
* diagnosed diseases
* use of nutritional supplements
Etodalac, Etoricoxib and Dexamethasone for Prevention of Pain ,Swelling and Trismus Following Third Molar Surgery

The purpose of this study is to determine whether Etodalac, Etoricoxib and Dexamethasone are effective for Prevention of Pain ,Swelling and Trismus Following Third Molar Surgery


Eligibility Criteria:
Inclusion Criteria:

* Patients who are refered for third molar extraction to our center
* Must be able to swallow tablets

Exclusion Criteria:

* Diabetes mellitus
* Thyroid diseases
* Cardiovascular diseases
* renal diseases
* hepatic diseases
* respiratory system diseases
* adrenal diseases
* Allergy to Etodalac, Etoricoxib or Dexamethasone
* Gastric ulcers
* psychiatric diseases
* Pregnant or breast feeding womans
Treatment-related Quality of Life and Patient-Centred Care With Infertility

This study was conducted in a cross-sectional descriptive type with 160 infertile women who were treated in the IVF Clinic of a university hospital between July - October 2020 in order to evaluate the effect of patient-centered care approach in infertility on treatment-related quality of life. The data of the study were collected face to face through the "Introductory Information Form" "Patient Centered Care Form for Infertile Women" and "FertiQol Treatment Module".


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with infertility
* Has no commnunication problems

Exclusion Criteria:

* Communication problems (e.g language)
* Diagnosed by diseases with reproductive problems but not infertility
Digital Health Physical Activity Program for Older Family Care Partners of Patents With Heart Failure

The purpose of the Aim 3 study is to conduct a pilot randomized controlled trial to assess feasibility and preliminary effects of the TPA4You intervention.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 60 years
* Involved in caring for a household member aged 60 years or older with the New York Heart Association Class II, III or IV HF
* Provide at least 10 hours/week of unpaid care for the past 6 months
* Physically able to engage in structured exercise such as walking, and upper body resistance exercises
* Engage in \< 30 min of moderate-intensity exercise on fewer than 3 days per week over the past 6 months
* Able to read, speak, and comprehend 5th grade English
* Own a smartphone
* Reachable by telephone, text messaging, and email

Exclusion Criteria:

* Medical or functional conditions precluding participation in the physical activity (PA) components of the intervention (e.g., inability to walk one block or climb stairs without chest pain, shortness of breath, dizziness; history of falls; or serious or unstable cardiovascular or pulmonary disease)
* Cognitive impairment (Telephone Interview for Cognitive Status \[TICS\]52 score \< 25)
* Inability to use technology
* Participation in a PA intervention in the previous 6 months
* Current participation in a PA or behavior change trial
Autonomic Nervous System Dysfunction and Peripheral Neuropathy in a Cohort of Asymptomatic Juvenile Diabetic Patients (Type I): A Case-Controlled Study

This is a case-controlled study using an innovative, non-invasive, FDA approved technology to measure the autonomic nervous system. Detection of unsuspected DPN or ANS dysfunction may allow physicians to re-assess current treatment and develop new dietary or pharmacological strategies. This also is an immense public health concern since there are currently 18 million diabetics in the United States and 220 million worldwide.

A consecutive cohort of 20 neurologically asymptomatic (absence of numbness, tingling, burning or pain in the feet) patients with Type I from the practice of Dr. Richard Noto (gatekeeper) and associates will be asked with their legal guardians to enroll in this case-controlled study using a battery of safe, neurological tests which are unlikely to be painful. A second group of 20 subjects who are nondiabetic and healthy (age/sex matched) will also be enrolled and undergo the same battery of neurological tests. The battery of tests is highly accurate, objective and safe. Subjects will be referred and enrolled from the private practices of community pediatricians. A BMI derived from the subject's height and weight will be assessed by Dr. Noto. Subjects who are felt to be acceptable by the inclusion criteria will then receive consecutive numbers from 1 to 40 and their initials will follow their specific number for each study.

Eligibility Criteria:
Inclusion Criteria:

* Cooperation of the subject and guardian are required for this 60-120 minute evaluation.
* Capable of understanding and complying with study protocol.
* Twenty (20) male/females with juvenile diabetes \[of at least 3 years duration and no longer than 7\] (Type I) who are neurologically asymptomatic without numbness, tingling, burning or pain in the feet, ages 10-18.
* Fasting blood glucose greater than 120 mg at the time of initial diagnosis or a HbA1C greater than 6.0 at the time of the initial diagnosis will indicate that individual is to be considered a diabetic.
* BMI ranges of acceptability are greater than 5th percentile and less than 85th percentile.

Exclusion Criteria:

* Symptomatic with neurological symptoms of numbness, tingling, burning or pain in the feet of either controls or diabetic subjects.
* On medications that can produce peripheral neuropathy, i.e. statins (Lipitor), Dilantin, anti-neoplastic drugs.
* Unable to understand informed consent, i.e. mental retardation, psychosis, communicative impairment, language barrier.
* Morbid obesity - maximum BMI greater than 85th percentile.
* Underweight status less than 5th percentile BMI.
COVID-19 - Implications on Surgeons' Burnout and Career Satisfaction

This is a cross-sectional survey which will be distributed online between surgeons. The survey was proposed by a consensus of consultants of surgery and revised by an improvement consultant. It consists of a semi-structured questionnaire that is provided in English language. The survey will be conducted online through an online survey development cloud-based software (SurveyMonkey®; San Mateo, CA, USA). Participants will be aware of the nature of the survey and informed that they will be listed as co-authors. Collected data will be confidential and anonymous.

The first sector of the questionnaire includes trainee demographics and baseline characteristics. Then the questionnaire aims to compare the trainee experience before and after the pandemic with focus on research activities, clinical, and surgical practice.

This is a cross-sectional survey which will be distributed online between surgeons. The survey was proposed by a consensus of consultants of surgery and revised by an improvement consultant. It consists of a semi-structured questionnaire that is provided in English language. A subsequent translation in different Language will provided based on geographical distribution. The survey will be conducted online through an online survey development cloud-based software (SurveyMonkey®; San Mateo, CA, USA). Participants will be aware of the nature of the survey and informed that they will be listed as co-authors. Collected data will be confidential and anonymous.

The first sector of the questionnaire includes trainee demographics and baseline characteristics. Then the questionnaire aims to compare the trainee experience before and after the pandemic with focus on research activities, clinical, and surgical practice.

Statistical analyses will be performed using SPSS v. 20. Data distribution will be tested for normality using the Kolmogorov-Smirnov test and the Shapiro-Wilk test. Categorical variables will be expressed as group percentages and will be compared for independent samples using the Chi-square test. Continuous data of the survey will be presented as medians with ranges or means and standard deviations. A comparison of continuous data will be compared for independent samples using the T-test or Mann-Whitney test according to the data distribution. Spearman correlation coefficient will be used for further assessment of the strength of the association between variables. The statistical significance level will be set at \<0.05.

Eligibility Criteria:
Inclusion Criteria:

* The Survey is targeting surgeons of all specialities; Cardiothoracic, General, Neurosurgery, Oral and Maxillofacial, Otolaryngology, Pediatric, Plastic, Trauma and Orthopedic, Urology, and Vascular Surgery. Furthermore, Gynecological Oncology and Urogynecology surgeons are invited.

Exclusion Criteria:

* other specialities other than surgery
Family Assessment Motivation, and Linkage Intervention (FAMLI)

The R34 study will integrate existing tools for use with JJ populations and examine the feasibility, acceptability, and preliminary efficacy of a caregiver-youth intervention aimed at increasing SU treatment initiation. The adaptive intervention incorporates three evidence-based components: 1) assessment of motivation and linkage-related barriers with personalized feedback, 2) Mapping-Enhanced Counseling (MEC) for improving readiness for change and interpersonal communication, and 3) Active Linkage (AL) for addressing logistical barriers to service initiation. Youth-caregiver dyads will be randomly assigned to receive an initial dose (2, 1-hr sessions) of either MEC or AL. After 30 days, participants will be classified as Responders (1 or more services initiated) or Non-responders (no service initiation). All participants will be randomized to one of two intervening interventions: an additional dose (2, 1-hr sessions) of the initial intervention (MEC or AL) or a different dose (2, 1-hr sessions of the other). The specific aims are to 1) integrate and adapt appropriate evidence-based intervention components as a dyadic intervention approach for JJ youth and caregivers; 2) test the feasibility, acceptability, and optimal configuration of the dyadic intervention components and the protocol used to evaluate effectiveness (including feasibility of recruitment, implementation, measurement); and 3) preliminarily explore a) whether an initial dose of MEC or AL is sufficient for promoting early initiation and engagement, b) whether an additional dose of MEC or AL or a change in dose is more effective, and c) which component sequence is most effective. Primary outcomes include youth (initiation of assessment or counseling; counseling attendance) and caregiver (attendance at assessment, first counseling, and/or family sessions) measures. Secondary outcomes include youth and caregiver attitudes (problem recognition, desire for help), normative beliefs (SU norms), perceived control (stressors and obstacles), and youth SU (self-report corroborated by UA results). The study addresses the sizeable gap in service receipt among JJ youth by addressing family engagement, and focuses on improving motivation to change, linkage to services, and treatment engagement.


Eligibility Criteria:
Inclusion Criteria:

* pre or post adjudicated or deferred prosecution
* have an identified SU need within the past 12 months (confirmed by the TCU Drug Screen-5 during initial assessment)
* speak English
* no indication of active suicide risk
* can identify one parent/guardian/responsible adult (caregiver) that is willing to participate who speaks Spanish or English
Microbiota Transplantation in Solid Organ Transplantation

Solid organ transplantation (SOT), an alternative therapy for end-stage diseases, offers increased longevity and better quantity of life. Posttransplant complications such as gastrointestinal symptoms, infection, and graft rejection increase risk with graft failure and death. However, the treatment of abovementioned complications remains unsatisfactory. Gut dysbiosis has been reported in patients with SOT, especially in patients with posttransplant complications. Recipients are more susceptible to gut dysbiosis as long-term use of immunosuppressants, antibiotics and corticosteroids. Restoring gut microbiome may be a promising therapy for posttransplant complications. Washed microbiota transplantation (WMT) is a newly improved methodology of fecal microbiota transplantation based on automatic facilities, washing process and a new delivery routine. In this study, investigators aimed to evaluate the efficacy and safety of WMT for postoperative complications in SOT.


Eligibility Criteria:
Inclusion Criteria:

1. solid organ transplantation recipients;
2. suffering from gastrointestinal symptoms (e.g. diarrhea, constipation, abdominal pian), infection (e.g. Clostridium difficile) post-transplantation and so on;
3. is willing to undergo WMT and provide written informed consent.

Exclusion Criteria:

1. patients with history of gastrointestinal diseases or homologous pathogen infection pre-transplant;
2. pregnant or lactating females;
3. expected survival\<1 months;
4. unable to understand the purpose of the study, communicate effectively with investigators and comply with all study procedures;
5. follow up less than 1-month post-WMT;
6. other conditions judged by investigators not suitable for study participation.
STEPS Trial - Spheramine Safety and Efficacy Study

The purpose of the study is to explore the safety, tolerability and efficacy of Spheramine (cultured human retinal pigment epithelial cells on microcarriers) in Parkinson's Disease patients with advanced disease who have insufficient symptom control by optimum oral medication. Patients are randomized to receive Spheramine injections into both hemispheres or a sham surgical procedure in a ratio of 1:1. A three month pretreatment period must be completed prior to surgery. Time to endpoint is 24 months.

This study has previously been posted by Berlex, Inc. and Schering AG, Germany.Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc., Schering AG Germany has been renamed to Bayer Schering Pharma AG, Germany. Bayer HealthCare Pharmaceuticals, Inc.and Bayer Schering Pharma AG, Germany are the sponsors of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Advanced Parkinson's disease for at least 5 years
* Good response to L-dopa
* Age 30 to 70 years
* Optimum oral therapy

Exclusion Criteria:

* Tremor only
* Dementia
* Very severe dyskinesia
* Previous brain surgery including deep brain stimulation
* Malignant disease