cyrilzakka/clinical-trials huggingface dataset:
Prasugrel Versus High Dose Clopidogrel in Clopidogrel Resistant Patients Undergoing Chronic Hemodialysis

Clopidogrel administration is essential in patients undergoing percutaneous coronary intervention, in patients with previous stroke, in patients under chronic hemodialysis via fistulae and in patients with chronic atrial fibrillation if coumarin administration is not a viable option. Patients with chronic renal failure present lower clopidogrel response compared to those with normal renal function. Additionally, hemodialysis via the dialysis filter causes a decrease in glycoprotein platelet receptors, potentially associated with thienopyridine hyporesponsiveness. Clopidogrel resistant patients as assessed by VerifyNow P2Y12(Accumetrics)will be randomized in 1:1 fashion to prasugrel 10mg/day or clopidogrel 150mg/day. On day 15±2 days a crossover directly to the alternate treatment group will be carried out, without an interventing washout period. All patients will undergo platelet reactivity assessment, documentation of major adverse cardiac events and documentation of any serious adverse events(stroke, bleeding)at day 15 and day 30.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years old
2. History of chronic renal failure under hemodialysis for at least 6 months
3. Under clopidogrel 75mg/day treatment for at least 7 days before randomization
4. Informed consent obtained in writing

Exclusion Criteria:

1. Treatment with other investigational agents (including placebo) or devices within 30 days prior to randomization or planned use of investigational agents or devices prior to the Day 30 visit.
2. Pregnancy
3. Breastfeeding
4. Inability to give informed consent or high likelihood of being unavailable for the Day 30 follow up.
5. Malignancy
6. Acute coronary syndrome or hemodynamic instability within 30 days prior to randomization
7. Requirement for oral anticoagulant prior to the Day 30 visit
8. Requirement for discontinuation of thienopyridine treatment prior to the Day 30 visit
9. Treatment with IIb/IIIa inhibitors within 30 days prior to randomization or planned administration prior to the Day 30 visit
10. Known hypersensitivity to prasugrel or clopidogrel.
11. History of gastrointestinal bleeding, genitourinary bleeding or other site abnormal bleeding within the previous 6 months.
12. Other bleeding diathesis, or considered by investigator to be at high risk for bleeding on thienopyridine therapy.
13. Any previous history of ischemic stroke, intracranial hemorrhage or disease (neoplasm, arteriovenous malformation, aneurysm).
14. Thrombocytopenia (\<100.000 / μL) at randomization
15. Known liver failure (bilirubin \> 2mg/dl)
Evaluating Care Integration for Children with Special Health Care Needs V1.0

The Evelina London Children's Hospital (ELCH) is planning to integrate care for children with special health care needs (CSHCN) using a package of support, including 1) family support workers to manage care coordination and support parents, and 2) 'navigation' packs outlining key services, for both the services users and providers.

This study aims to explore the views and experiences of key stakeholders involved with these services, including the parents/caregivers of CSHCN, and professionals/staff team members. These will be explored using semi-structured qualitative interviews.

There has been a push at the policy level to implement integrated care approaches in the USA and the UK. However, few integrated care models have been evaluated, particularly for children with special health care needs (CSHCN). This is an important group with high levels of needs, and complex and intensive use of services, and which the research team hypothesize could benefit immensely from care integration. This project aims to qualitatively evaluate care integration implementation for CSHCN, to understand how and why integrated services do (or do not) work to improve integration of care.

This research gap was confirmed by a systematic literature review on these topics, conducted by the research team (in final draft stages). The research team also facilitated workshops with local families of CSHCN and professionals to understand their experiences of care delivery, current concerns, and what should be improved.

Synthesizing information from both the systematic literature review and the workshops led to the development of this research project, which will investigate how care can be better integrated for CSHCN and their families.

The themes to be investigated will include:

i. To explore the perceptions of key stakeholders on the overall quality of life, wellbeing, and community inclusion of CSHCN and their parents/caregivers.

ii. To explore the perceptions of key stakeholders on CSHCN and family satisfaction with care, and care integration, including equity of access and how this is impacted by integration.

iii. To explore the views of key stakeholders on the impact of the new key worker/care-coordinator service on the CSHCN and family, including school, work, family, and healthcare use.

With the learning from this project, the research team also aim to develop a model of care that can be evaluated at a larger scale in a later study and, if shown to be successful, delivered throughout the NHS and internationally.

Eligibility Criteria:
Inclusion Criteria:

* Parents/care givers of CSHCN
* Staff and professional stakeholders involved (either directly or indirectly) with CSHCN

Exclusion Criteria:

* Participants under the age of 18 years
* Participants who are unable to speak and understand English
Microvascular Invasion Artificial Intelligence Prediction Via Contrast-enhanced Ultrasound With Explainability

An artificial intelligence (AI) model to predict MVI of HCC using contrast-enhanced ultrasound was constructed. This model also has biological explainability. The investigators named it as MAPUSE (MVI AI prediction via contrast-enhanced ultrasound with explainability).

The goal of MAPUSE study is to prospectively test the performance of MAPUSE model on MVI prediction and its biological correlation in different geographical areas of China.

The presence of microvascular invasion (MVI) in hepatocellular carcinoma (HCC) is a critical prognostic indicator, but its preoperative diagnosis remains challenging. Contrast-enhanced ultrasound (CEUS), with its dynamic microvascular imaging capability, holds promise in prediction of MVI.

The investigators constructed an artificial intelligence (AI) model to predict MVI using contrast-enhanced ultrasound. This model also has biological explainability. We named it as MAPUSE (MVI AI prediction via contrast-enhanced ultrasound with explainability).

The goal of MAPUSE study is to prospectively test the performance of MAPUSE model on MVI prediction and its biological correlation in different geographical areas of China.

The performance of MAPUSE is to be tested in two prospective testing cohorts from two centers in southern and northern China. Before surgery, patient CEUS videos will be collected and analysed by MAPUSE model to generate an MVI risk score. According to the postoperative pathological diagnosis of MVI (golden criterion), the result of MAPUSE will be evaluated. Parameters include area under curve (AUC), accuracy (ACC), sensitivity, specificity and F1-score.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>18 years old.
2. The HCC diagnosis and the presence of MVI were confirmed by surgical pathology.
3. Complete and clear CEUS videos obtained within two weeks preoperatively.

Exclusion Criteria:

1. Unqualified CEUS images.
2. Missing surgical pathological diagnosis.
3. Lesions underwent local treatments.
4. Non-HCC diagnosis
Botox Versus Oxybutynin as First Line Treatment for the Poorly Compliant Pediatric Neurogenic Bladder

The purpose of this study is to investigate the use of Botulinum Toxin A as primary therapy for children with neurogenic bladder due to spina bifida and compare results with standard oral oxybutynin therapy. This study hopes to demonstrate that Botulinum Toxin A can maintain or improve bladder storage function without side effects associated with oxybutynin use.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of spina bifida and neurogenic bladder
* Performing clean intermittent catheterization (CIC)
* Taking 0.3-0.4 mg/kg/day of oxybutynin for a poorly compliant bladder
* Has not had previous bladder surgery
* Has had a urodynamic or videourodynamic study done within the last 6 months
* Upper motor neuron (UMN) type bladder demonstrated on last urodynamic study
* Urodynamic study (UDS) showing either detrusor leak point pressure \>40cm H2O; 30cm below capacity \<60% of total bladder capacity, 20 cm capacity \<70% of bladder capacity
* Able and willing to complete CIC Diaries and Quality of Life Questionnaires
* Consent and assent given to participate in trial

Exclusion Criteria:

* History of lung disease, recurrent aspiration or severe neurological impairment which may increase risk of Botox toxicity or anesthesia
* Positive urine culture
* Known allergy to Botox
The Relationship Between Psychosocial Factors Affecting Pain Perception and Physical Activity Level in Pregnant Women With Lumbopelvic Pain

Lumbopelvic pain (LPP) is a common condition encountered during pregnancy. During pregnancy, 50% of women experience LPP. This study was planned to show the relationship between psychosocial factors affecting the perception of pain such as pregnancy-related psychosocial factors, pregnancy-related distress, catastrophization and pain self-efficacy and physical activity level in pregnant women with lumbopelvic pain. This study was conducted using the questionnaires.

In pregnant women with lumbopelvic pain, physical activity during pregnancy has many positive effects on both maternal and infant health. Therefore, it is necessary to know the factors affecting physical activity during pregnancy and make arrangements regarding these factors. This study was planned to reveal the relationship between pregnancy-related psychosocial factors, pregnancy-related distress, catastrophizing, and pain self-efficacy, which affect pain perception, and physical activity level in pregnant women with lumbopelvic pain. The study was conducted with 60 pregnant women who met the inclusion criteria. This study was conducted using the questionnaires prepared in the electronic environment and sent to the participants. This study aims to investigate the relationship between the psychosocial factors affecting pain perception and physical activity levels in pregnant women with LPP.

Eligibility Criteria:
Inclusion Criteria:

* Women between the ages of 18-45, who had pain in the lumbopelvic region for more than a week, who had pain between 1-10 according to the VAS, who could read and understand Turkish, who were in the second or third trimester of pregnancy, and who did not exercise regularly before pregnancy were included in this cross-sectional and descriptive study.

Exclusion Criteria:

* having pregnancy complications (preeclampsia, pregnancy-related hypertension, diabetes, etc.), having gynecological or urological problems leading to pain during pregnancy, and having a history of acute or chronic disease, surgical intervention and trauma in the musculoskeletal or nervous system.
Clinical Characteristics and Surgical Outcomes of Full-thickness Macular Hole Without Focal Vitreomacular Traction.

This multicenter, retrospective, observational comparative study. We occasionally encounter FTMHs in which PVD has not been achieved and VMT is absent. These FTMHs cannot be defined by stage in the Gass1) or IVTS3) classification. It is not known whether traction is involved in the development of these atypical macular holes, but they are often classified as Gass stage 2 or 3 according to the size of the hole.

The aim of this study was to investigate the clinical features and surgical outcomes of FTMHs without focal VMT and to discuss possible underlying mechanisms.

The clinical characteristics and surgical outcomes the patients diagnosed with FTMH without focal VMT in the macula (classified as VMT-) are presented, in addition to a comparative analysis of the patients presenting with classic stage 2 FTMH with focal VMT (classified as VMT+) according to international classification criteria.

Eligibility Criteria:
Inclusion Criteria:

- macular hole without posterior vitreous detachment at the fovea

Exclusion Criteria:

* macular hole with posterior vitreous detachment at the fovea
* Stage1.3.4 macular hole
* Macular hole-associated retinal detachment
* Macular hole with subretinal hemorrhage
* Traumatic MH
Manipulating Narrative Presentations of Information to Encourage Good Foot Care Practice in People With and Without Diabetes Mellitus

The study explores the role of health messages (narrative, non-narrative vs. control condition \[no message\]) to enhance good foot care practices among people with diabetes and the general population.


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of age at the time of consent;
* able to read and speak the English language;
* able and willing to give written informed consent prior to study entry;
* able to complete the protocol requirements

Exclusion Criteria:

* has a cognitive impairment or acute psychopathology (self-reported formal diagnoses of down syndrome, traumatic brain injury, brain tumour, autism, dementia, schizophrenia, and/or schizoaffective disorder), ie that which could interfere with his or her ability to provide written consent and complete the study
* has taken part in any other research on foot care with the University of Chichester in the past year
A Study of Rizatriptan Co-Administered With Acetaminophen for the Treatment of Acute Migraine

The purpose of this study is to test an experimental drug combination of two medications currently approved by the Food and Drug Administration (FDA) for migraine headache or other pain. These are called rizatriptan given with acetaminophen.


Eligibility Criteria:
Inclusion Criteria:

* Subject is at least 18 years of age
* Subject has at least a 6 month history of migraine, with or without aura
* Subject can distinguish between migraine attacks and other types of headaches
* Subject of childbearing potential agrees to use adequate contraception

Exclusion Criteria:

* Subject typically has fewer than 1 or greater than 6 migraine attacks per month
* Subject typically has greater than 10 headache days per month
* Subject has evidence of ischemic heart disease
* Subject has uncontrolled high blood pressure
* Subject has a history, within 1 year, or current evidence of drug or alcohol abuse

\*This list is not all inclusive\*
OMM Utilization in the Clinical Setting

The SPECIFIC AIM of this research study is to evaluate the utilization, effectiveness, and safety of osteopathic manipulative treatment (OMT) using data collected from patients receiving OMT in the clinical setting within the established practice-based research network DO-Touch.NET.

. The HYPOTHESES of this research study are the following:

* OMT is primarily used in the treatment of musculoskeletal pain disorders.
* Patients receiving OMT will have decreased symptoms and improved quality-of-life.
* The most common side effect reported by patients receiving OMT will be muscle soreness.

While many physicians and patients are convinced of the efficacy of osteopathic manipulative treatment (OMT), strong evidence supporting such a claim is sparse.

The objectives of this study are to determine the scope of conditions currently being treated with OMT, identify conditions that are responsive and unresponsive to OMT, determine which osteopathic manipulative techniques are most beneficial in responsive conditions, determine if certain patient characteristics are present in those who are responsive to OMT, and determine which physicians have consistently positive outcomes with OMT for certain conditions.

As an observational study, this study will not impact any aspect of the care received by the patient participants. Data will be collected from patients and physicians through a series of questionnaires incorporated into an online data collection system. DO-Touch.NET will be utilized for physician recruitment, site personnel training, members portal for accessing study materials, coordination, and physician data collection. Assessment Center will be used for participant registration, data collection and study tracking/reporting. Patients aged 18 years and older who receive OMT from a participating physician at a DO-Touch.NET site will be recruited to participate in the study. Background data will be collected from the patients including demographics, presenting symptoms and severity, and impact on quality of life. Data on medical history, examination, diagnosis, treatment, and home instructions/plan will be gathered from the physician. On a daily basis for a week after OMT, data will be collected from the patient regarding symptom severity and health changes. Impact of symptoms on quality of life will be reassessed after one week. These data will be collected from a patient over a series of office visits when applicable.

Ongoing observation of both positive and negative outcomes associated with OMT directly from patients will be increasingly more valuable, producing and sustaining a current evidence base for OMT and identifying priorities for further osteopathic research.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged 18 years and older
* Patients receiving OMT at a participating clinic

Exclusion Criteria:

* Patients with difficulty communicating in English, have dementia, or have psychological conditions that may impact their ability to provide accurate information
* Research team members and participating clinic employees
Improving Antibiotic Prescribing for Urinary Tract Infections in Frail Elderly

The purpose of this study is to determine whether a tailored multifaceted antibiotic stewardship intervention reduces antibiotic use for urinary tract infections in residential care homes and nursing homes attended by general practitioners. This will be evaluated in a pragmatic cluster randomised controlled trial using a modified community-based participatory action research approach.

Rationale:

Almost 60% of antibiotics in frail elderly is prescribed for alleged UTI. About half of the antibiotics for UTI in this population are prescribed for non-specific signs and symptoms; a substantial part of these prescriptions might not be necessary.

Research question:

Does a tailored multifaceted antibiotic stewardship intervention reduce antibiotic use for UTI in residential care homes and nursing homes attended by general practitioners (GPs)?

Study design, setting and population:

A pragmatic cluster randomised controlled trial using a modified community-based participatory action research approach. In the intervention group the latest UTI guidelines (which are standard care) are actively implemented at the level of the GP/caregivers. Residents ≥ 70 year with ADL dependency from 34 care homes + attending GP practices will participate in Norway, Sweden, Poland and the Netherlands.

Methods:

The study has two measurement periods; a baseline period (5 months) and a follow-up period (7 months). In between the antibiotic stewardship intervention will be tailored and implemented in intervention practices. GPs will prospectively register suspected UTIs on standardized registration forms and (study) nurses/assistants will follow-up patients at day 7 and day 21 for each UTI.

Patients will be enrolled prior to the start of the study.

* June-August 2019: patient are recruited, informed consent is obtained, baseline characteristics of patients are recorded
* Sept 2019: study starts (from this moment onwards, the outcomes are being assessed).

Data analysis:

The primary analysis will be to assess the number of prescriptions of antibiotics for suspected UTI in the follow-up period, correcting for the baseline period and controlled for pre-specified confounders, using a generalized linear mixed model for Poisson distributions.

Eligibility Criteria:
Inclusion Criteria:

* physical and/or mental disabilities and ADL dependency requiring residential care or nursing home care
* attended by general practitioners
* not on continuous prophylactic antibiotic use

Exclusion Criteria:

* in hospice-care
* very limited life expectancy (≤1 month)
* no longer wish to participate
* start continuous antibiotic (prophylaxis)
* die or move away from the residential care home / nursing home

If patients are excluded within 2 months after inclusion, they will be taken out of the study. In other words: patients need to be included for at least 2 months to contribute data to the study.
Imatinib Versus Imatinib and Peg-Interferon in Patients With Ph+ CML and Complete Cytogenetic Response After Imatinib Therapy

The study is controlled and randomized in Philadelphia-positive chronic myeloid leukemia (Ph+ CML) patients with complete cytogenetic response after more than one year of imatinib therapy. The aim is to explore a possible benefit in the addition of peg-interferon (Peg-IFN) to imatinib, in terms of the rate of achievement, molecular remission, and response duration.


Eligibility Criteria:
Inclusion Criteria:

* Ph+ CML patients in complete cytogenetic response (CCR) after more than 1 year of imatinib therapy.

Exclusion Criteria:

* Patients in imatinib study
* Patients with a history of intolerability to interferon.
* Patients with less than CCR or less than one year of imatinib therapy.
Group Music Therapy Intervention With Informal Carers of Elderly Dependents

To evaluate the effects of a group music therapy intervention with informal caregivers of elderly people on clinical psychological symptoms, taking into account variables such as caregiver burden, anxiety and depression.


Eligibility Criteria:
Inclusion Criteria:

* to be the main informal caregiver of an elderly dependant
* the dependant person has to be over 60 years of age
* to be over 18 years of age
* having signed the informed consent form accepting the assessment and intervention

Exclusion Criteria:

* not residing in Spain
* being under 18 years
* having uncompensated sensory deficits that prevented the administration of the assessment protocol;
* illiteracy.
The Impact of COVID-19 on Maternal and Neonatal Outcomes

The novel coronavirus (SARS-CoV-2) infection (COVID-19) has caused a worldwide pandemic. There is still much that is unknown regarding the virus, especially its effects on pregnancy, the fetus, and the neonate. This study seeks to evaluate adverse pregnancy and neonatal outcomes related to COVID-19 infection.

The FDA has authorized emergency use authorization for the SARS-CoV-2 messenger ribonucleic acid (mRNA) vaccines from Pfizer and Moderna. Pregnant women were excluded from the Phase III clinical trials of the mRNA vaccines. There are no studies that have evaluated functional antibody responses, antibody reactivity to variant viruses, T cell frequencies or activity, or protection against infection or development of COVID-19. Having a more detailed understanding of how pregnancy and lactation alters the longevity, specificity, and activity of antiviral antibody and T cell-mediated immune responses to COVID-19 mRNA vaccines is essential for the FDA to inform future recommendations and regulation of these vaccines.


Eligibility Criteria:
Inclusion Criteria for Vaccine Arm:

* All pregnant women receiving their prenatal care from the Johns Hopkins Hospital or Johns Hopkins Bayview Medical Center, who are planning to receive an mRNA COVID vaccine and/or a third dose booster during their pregnancy.

Exclusion Criteria:

* Prior COVID-19 infection.

Inclusion Criteria for Sample Collection Arm:

* All pregnant women admitted to the Johns Hopkins Hospital or Johns Hopkins Bayview Medical Center for delivery and their newborn (at birth), will be considered for enrollment.
* Pregnant patients with a positive COVID-19 test during their pregnancy or at the time of admission to Labor \& Delivery.

Exclusion Criteria:

* None