cyrilzakka/clinical-trials huggingface dataset:
Assessment of Fitness After Neoadjuvant Chemoradiotherapy in Rectal Cancer Patients

Neoadjuvant chemoradiotherapy (NACRT) prior to surgery for lower gastrointestinal (colon and rectal) cancer is associated with improved survival, but also adversely affects physical fitness, potentially rendering patients unfit for major surgery or increasing the risk of adverse outcome (death and serious complications) after major surgery. The investigators aim to obtain pilot data showing that neoadjuvant chemoradiotherapy (NACRT)reduces objectively measured exercise capacity (fitness).

Purpose: To evaluate the effects of chemoradiotherapy on pre-operative fitness of patients prior to major colorectal cancer surgery.

Design: Patients will act as their own case-control.

Patients will be consented at the earliest available opportunity following the decision that they have surgically treatable disease and they consent to pre-operative NACRT. Consent for the study will be gained as an outpatient. At "visit 1" patients will undergo CPET, as is our current standard practice, prior to commencing neoadjuvant chemoradiotherapy. As part of the assessment, they will have pulmonary function testing (static lung volumes, lung diffusing capacity). They will then undergo 6 weeks of long course NACRT, as is standard current practice at our institution. At "visit 2", approximately four to six weeks following chemoradiotherapy another CPET test will be repeated. This is also current standard practice at our institution. Data from visit 1 and visit 2 will be compared in a paired manner. A statistician will be consulted to assess the degree of normality of the data, the statistical tests to use, and for power calculations. At no point will any treatments be postponed or changed solely for the purposes of collecting data for the research.

Eligibility Criteria:
Inclusion Criteria:

* All patients listed to undergo neoadjuvant chemoradiotherapy for downstaging of colorectal cancer, with a view to undergo elective colorectal surgery at Aintree University Hospitals.

Exclusion Criteria:

* Unable to consent.
* Under 18 years of age.
* Significant ischaemic changes of \>1.5mm symptomatic and \> 2mm asymptomatic observed on routine cardiopulmonary exercise test.
* Any other absolute contraindications to CPET based on the ATS guidelines.
Web-Based Respiratory Education About Tobacco and Health Phase II

The primary aim of this study was to develop an interactive Internet-based program (WeBREATHe: Web-Based Respiratory Education About Tobacco and Health) to train pediatric respiratory therapists and nurses to provide brief, hospital-based tobacco cessation interventions to parents of pediatric patients. The WeBREATHe program was based on a Phase I prototype which was evaluated with 50 pediatric respiratory therapists and nurses.

In Phase II, the investigators redesigned and expanded the program with input from 50 educators, nurses and respiratory therapists from Cincinnati Children's Hospital Medical Center. Then the investigators evaluated the Phase II program in a randomized trial in which 215 respiratory therapists and nurses from two large, urban children's hospitals were randomly assigned within hospital to either the Intervention (Training) Condition, or to a Delayed Treatment (Training) Control condition.

Participants' demographic and tobacco use history were measured at baseline, and tobacco cessation intervention behaviors, attitudes, knowledge, perceived barriers, and self-efficacy regarding delivery of a tobacco cessation intervention were measured at baseline, 1 week post-training, and at 3 months post-training. User satisfaction measures were also collected at 1 week post-training from Intervention Condition participants. The investigators hypothesized that participants in the Intervention Condition would have increased tobacco cessation behaviors, positive attitudes and self-efficacy, and decreased perceived barriers than participants i the Delayed-Treatment Control Condition.

Following evaluation, the investigators developed a final version of the interactive training program and created the administrative infrastructure for a marketable product.


Eligibility Criteria:
Inclusion Criteria:

* Must be a respiratory Therapist, nurse or nurse practitioner at the 2 pediatric hospitals participating in the study.
* Must be at least 18 years of age.

Exclusion Criteria:

* Under 18 years of age.
Evaluation of CL Detect™ Rapid Test to Detect Cutaneous Leishmaniasis

This study is a single-site trial assessing the specificity of CL Detect™ Rapid Test versus the gold standard for Leishmania diagnosis in the US which is microscopic identification of Leishmania amastigotes in a stained lesion sample. Subjects will be patients who present for dermatology consultation with a primarily ulcerated lesion. After informed consent is obtained and the subject is screened for eligibility, 2 diagnostic samples will be collected from the subject's lesion in the following order: 1) one sample will be obtained with a dental broach for use with the CL Detect™ Rapid Test and 2) a second sample will be obtained by scraping for use in the microscopic identification of amastigotes. Samples will be analyzed by microscopy and CL Detect™ Rapid Test. The CL Detect™ Rapid Test will be performed by different operators who are clinical staff members. These staff members, blinded to each other's results, will evaluate the samples from each method independently. Each of the 150 study subjects will be followed administratively to the point where a diagnosis is established (if possible) for their tested lesion, even if that diagnosis is not cutaneous leishmaniasis (CL). If a specific diagnosis cannot be determined for a non-CL lesion, the investigator will assign a "likely etiology" (eg, infectious, oncological, immunological, vascular, or "undetermined/other" origin). Based on the diagnosis determined for each lesion, subjects will be referred for appropriate treatment.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Subject is able to give written informed consent
* Subject has a skin ulcer that satisfies the following criteria for an index lesion:
* less than 4 months in age
* primarily ulcerative, not purely verrucous or nodular, and does not have clear clinical evidence of cellulitis
* in a location suitable for collecting samples by dental broach and scraping
* In the opinion of the investigator, the subject is capable of understanding and complying with the protocol

Exclusion Criteria:

* Received treatment for leishmaniasis or any treatment to the lesion even if not previously diagnosed as leishmaniasis such as azoles, cryotherapy, imiquimod, thermotherapy, photodynamic therapy, within 2 months prior to signing the consent form, with the exception of mercurochrome
Remote-by-Default Care in the COVID-19 Pandemic

18 month study, funded by ESRC COVID-19 research fund. The aim is to explore and support the rapid shift from face-to-face to remote (telephone and video) conversations in primary care. There are three components: a study of clinical interactions and decision making (micro); four locality-based organisational case studies of new models of care (meso); abd a a study of how digital innovation can support NHS infrastructure and vice versa (macro).

18 month study, funded by ESRC COVID-19 research fund. The aim is to explore and support the rapid shift from face-to-face to remote (telephone and video) conversations in primary care. There are three components: a study of clinical interactions and decision making (micro); four locality-based organisational case studies of new models of care (meso); abd a a study of how digital innovation can support NHS infrastructure and vice versa (macro). The methods are mainly qualitative (interviews, virtual ethnography, analysis of documents, micro-analysis of conversations) and are designed to inform action research.

Key deliverables:

At least two evidence-based assessment tools: qualitative (questions for remote assessment of breathlessness) and quantitative (a COVID-19-specific early warning score)

Transferable lessons about how to achieve rapid spread and scale-up, spread in real time through our extensive intersectoral networks

Strengthened infrastructure for supporting digital innovation in the NHS

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria for interviews

Willing and able to give informed consent for participation

Aged 18 years or above

Staff involved in delivering remote-by-default services in the frontline or 'back offices'

Patients/carers who have crossed paths with primary care services during the Covid pandemic.

Pharmacy case studies:

Staff involved in delivering remote pharmacist consultation services in the frontline or 'back offices'

Patients/carers who have crossed paths with community pharmacy primary care services during the COVID-19 pandemic.

Inclusion criteria for video and telephone consultations

Patients who have remote primary care consultation regarding symptoms associated with COVID-19 and their clinicians (based in Oxford/Thames Valley) who have agreed to participate in the study

Inclusion criteria for focus groups

Patients that have experienced self-reported 'long Covid' symptoms (for patient only focus groups)

Clinicians that have experienced self-reported 'long Covid' symptoms (for clinician only focus groups)

Exclusion Criteria:

Patients or clinicians who are too ill to be interviewed

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COPE - COVID-19 in Pregnancy and Early Childhood

Purpose: The emergence of a new coronavirus SARS-CoV-2 causing a novel infection in the human race resulting in a world-spanning pandemic came as a surprise and at a tremendous cost both for individual human lives as well as for the society and the health care sector. The knowledge on how this new infection affects both the mother and the unborn child as well as the outcomes for the mother and the child in the long run are unknown. What is known is based on case-reports and small case-series solely. Both the coronaviruses causing Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS) can cause a threat to pregnant women and their offspring, which leads to the question whether this could be the case also for SARS-CoV-2.

Aims: To establish a biobank of biological material from infected as well as non-infected pregnant women and their offspring. To combine this biobank with Swedish quality and health care registers, computerized patient charts and questionnaire data, enabling both short-term follow up, such as obstetric outcomes, as well as long-term outcomes both for mother and child. To study how the pandemic situation affects both the mother and her partner in their experience of pregnancy, childbirth, and early parenthood.

Design: A national Swedish multicentre study. Women are included when they have a positive test for SARS-CoV-2 or a clinical suspicion of coronavirus disease 2019 (COVID-19) (COVID-19 group). Pregnant women without COVID-19 symptoms will be included at their routine visits (Screening group). Blood samples and other biological material will be collected at different time-points. Additional predictors and outcomes are collected from the Swedish Pregnancy Register as well as obligatory Swedish health registers. The biobank and its linkage to health registers through the Swedish personal identification number will enable future research. Child development will be followed during the first year of life by questionnaires to the parents. Womens' and their partners' experience of childbirth and parenthood will be studied in form of questionnaires as well as in form of interviews.

Conclusion: This project will help obstetricians and neonatologists better recognize clinical manifestations of the virus, identify possible risk factors during pregnancy and tailor therapies alongside providing right level of surveillance and management during pregnancy, delivery, and child health care.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women 18 years of age and above
* Attending routine antenatal visits at a participating hospital during the study period or are strongly suspicious of or diagnosed with Covid-19 during pregnancy.
* For the questionnaire part: language knowledge (Swedish, English, Arabic, Somali)
* For the interview part: Swedish language knowledge

Exclusion Criteria:

• Another language but selected ones
Optimisation of Response for Organ Preservation in Rectal Cancer : Neoadjuvant Chemotherapy and Radiochemotherapy vs. Radiochemotherapy

Standard treatment of rectal cancer is rectal excision with neoadjuvant radiochemotherapy. A new concept suggests organ preservation as an alternative to rectal excision in good responders after neoadjuvant radiochemotherapy to decrease surgical morbidity and increase quality of life. The rational is the fact that 15% of patients have sterilized tumours after radiochemotherapy for T3T4 rectal cancer. The French GRECCAR 2 trial is the first phase III trial investigating this strategy: patients with T2T3 low rectal carcinomas (size ≤4 cm) received 50 Gy with capecitabine and good clinical responders (≤2 cm) were randomized between local and rectal excision. The main findings were: the rate of complete pathologic response was higher after radiochemotherapy for small T2T3 than for T3T4 tumours (40% vs 15% ypT0) and good pathologic responders (ypT0-1) were associated with zero positive mesorectal nodes.

The objective of the new trial is to increase the proportion of patients treated with organ preservation by optimizing tumour response. As compared to Folfiri, tritherapy Folfirinox has been shown to enhance the response rate. In patients with colorectal metastases, response rate and R0 resection were twice higher, resulting in improved survival. Folfirinox also increases response and chance of R0 resection rates in initially unresectable colorectal metastases, compared to standard or intensified bi-chemotherapy regimens. Adding two months of neoadjuvant chemotherapy (Folfirinox) before radiochemotherapy, the investigators expect to increase chance of organ preservation rate, as compared to radiochemotherapy alone.


Eligibility Criteria:
Inclusion Criteria:

* Rectal adenocarcinoma
* cT2T3
* cN0-1 (≤ 3 positive lymph nodes or size ≤8mm)
* Tumour size ≤4 cm
* Location ≤10 cm from the anal verge
* No distant metastasis
* Patient ≥18 years
* ECOG ≤2
* Effective contraception during the study
* Patient and doctor have signed informed consent

Exclusion Criteria:

* T1 or T4
* Tumour size \>4cm
* N2 (\>3 positive lymph nodes or size \>8mm)
* Tumour \> 10 cm from the anal verge
* Distant metastasis
* Chronic intestinal inflammation and/or bowel obstruction
* Contra indication for chemotherapy and/or radiotherapy
* Previous pelvic radiotherapy or chemotherapy
* Severe renal, hepatic insufficiency (serum creatinine\<30ml/min)
* Peripheral neuropathy \> grade 1
* Complete or partial Dihydropyrimidine deshydrogenase (DPD) deficiency (uracilemia ≥ 16 ng/mL)
* Concomitant treatment with millepertuis, yellow fever vaccine, phenytoin or sorivudine (or chemically equivalent)
* Pregnant or breast-feeding woman.
* Persons deprived of liberty or under guardianship
* Impossibility for compliance to follow-up
Analysis of Linked Health Insurance Claims and Clinical Registries to Determine Device Surveillance With Paclitaxel-coated Medical Devices

The GermanVasc/MDEpiNet Paclitaxel Study, aims to use routinely collected data from health insurance claims and registries. The longitudinal data of Germany's second-largest insurance fund, BARMER, includes the outpatient and inpatient medical care provided to ≈9.4 million German citizens (13.2% of Germany's population) involving \>21 million hospitalizations between January 1, 2008, and December 31, 2018. The BARMER cohort is similar to Western European countries and has been widely used for research projects. A regular random sample validation of internal and external validity is performed by the Medical Service of the Health Funds in Germany, and various peer-reviewed validation studies have been previously published. The GermanVasc clinical registry was implemented in 2018 as EU General Data Protection Regulation (GDPR) compliant registry platform to process routinely collected clinical data from more than 35 high-volume vascular centers in Germany. In an ongoing project of a large multispecialty and multidisciplinary research consortium (RABATT study, Principal Investigator: PD Dr. Christian-Alexander Behrendt), active surveillance and medical device evaluation methods were developed. The current study aims to determine the long-term safety and efficacy of paclitaxel-coated balloons and stents in peripheral arteries. It further aims to illuminate the underlying differences between the cohorts in randomized controlled trials (RCT) and real-world data that can possibly explain the diametrically opposed results in an ongoing international controversy.


Eligibility Criteria:
Inclusion Criteria:

* Fontaine stage II-IV
* Diabetic foot syndrome with chronic limb-threatening ischaemia
* Endovascular revascularisation procedure in the lower limbs
* Treatment between 2013 and 2017

Exclusion Criteria:

* Hybrid surgery
* Previous major amputation
* Previous cancer diagnosis
* Previous paclitaxel-exposure
* Previous percutaneous coronary intervention
* Previous revascularisation of the arteries in the lower limbs
Diabetic Retinopathy Screening in Private Practice

Introduction: Diabetic mellitus (DM) is a prevalent disease in Hong Kong (HK) and diabetic retinopathy (DR) is one of the most common complications of DM. Screening for DR is a cost-effective method to identify patients who are at risk of vision loss so that timely treatment can be provided to patients. In Hong Kong, the Hospital Authority has recently set up screening services (RAMP) in the government outpatient clinics and all DM patients attending these clinics will be screened at least once every two years and some every six months, according to their individual risks. However, those diabetic patients who attend the private sector for their primary care may not have access to this service.

Aim: This study from the University of Hong Kong aims to determine the characteristics of a sustainable approach to setting up an effective and quality-controlled screening service for DR in the private primary care sector of Hong Kong and to estimate the potential benefit to be gained in terms of impact on avoidable vision loss, costs of care and potential for further development of this model in chronic disease care.

Methods:A screening centre is being set up and a randomised study carried out in which screening will be offered at three different fee levels to subjects recruited by their general practitioner (GP). The following data will be collected (a) willingness to attend screening at the different fee levels (b) screening findings in terms of DR and other eye diseases (c) risk factors and other characteristics of those screened and unscreened. The information will allow us to estimate the level of fee which best combines effectiveness with sustainability in the longer term.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed to have diabetic mellitus
* Able to give informed consent

Exclusion Criteria:

* Pregnant women
FASENRA Regulatory Postmarketing Surveillance in Korea

As part of a post approval commitment, the MFDS has requested a study to characterize safety in patients who are treated with FASENRA for severe eosinophilic asthma and/or eosinophilic granulomatosis with polyangiitis (EGPA) by physicians in normal clinical practice settings. This study is designed to confirm or assess the known safety profile or identify previously unsuspected adverse reactions and to evaluate the effectiveness of FASENRA under conditions of routine daily medical practice in Korea.

This is a local, prospective, non-interventional, observational study is designed to evaluate safety and effectiveness of FASENRA in real world clinical practice setting in Korea. Adult patients with severe eosinophilic asthma and/or eosinophilic granulomatosis with polyangiitis (EGPA) who are initiating FASENRA for the first time as indicated by the MFDS will be included. At least 45 patients are followed for up 24 weeks and/or 48 weeks.

Patients will be treated as part of routine practice at Korean healthcare centers by accredited physicians. Each investigator will sequentially enroll patients who are initiating FASENRA for the first time and receive at least one dose until the target number of patients per center is reached. The characteristics of the study population and the FASENRA treatment schedule should be consistent with those described in the local product information at the time of enrolment (as the local product information may change). The study will enrol patients until the target number is reached.

All patients will be evaluated for safety during FASENRA use or for 30 days after their last dose of the surveillance drug if patients discontinued FASENRA before 24 weeks. Investigator's follow up of adverse events can be conducted by mail, phone calls, or e-mail for patients who discontinue early. The decision about the duration and discontinuation of treatment is solely at the discretion of the treating investigator with agreement of the patient.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18 years and older
2. Patients with severe asthma with an eosinophilic phenotype eligible for first time treatment with FASENRA according to the indication as indicated in the locally approved prescribing information
3. Patients with evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria:

1. Hypersensitivity to the active substances or to any of the excipients
2. Current participation in any interventional trial
Integrative Approaches for Cancer Survivorship

The purpose of this study is to determine whether a four-month manualized Ayurvedic intervention will improve quality of life in recent breast cancer survivors.

Cancer associated symptoms and impaired quality of life remain significant problems for patients despite advances in cancer treatment. Few effective treatment options exist for these symptoms. Integrative medicine is rising in popularity in the United States; however, few integrative medicine modalities have been rigorously studied. Ayurveda, a whole system of medicine that originated in the Indian subcontinent, has its own system of diagnostics and therapeutics, and among its strengths are wellness and prevention. We aim to perform a prospective single arm clinical study of a manualized Ayurvedic approach in breast cancer survivors with impaired quality of life. Specifically, we aim to develop the manualized Ayurvedic intervention; to assess feasibility; and to determine whether clinically meaningful effects can be achieved with the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Female breast cancer survivor who is over 1 month and less than 12 months beyond the completion of primary therapy (surgery, radiation, and chemotherapy)
* Having received chemotherapy as part of their primary therapy for breast cancer
* Be in a complete remission
* Aged 18 years or older
* Able to read, write, and understand English
* Karnofsky Performance Status (KPS) 67 greater than 60.
* Ability to give informed consent

Exclusion Criteria:

* Having received Ayurvedic treatment within 2 months of study enrollment
* Receiving chemotherapy or radiotherapy at the time of study enrollment. Trastuzumab therapy is not exclusionary.
* Being within 1 month (before or after) of surgery for breast cancer (including breast reconstructive surgery). Smaller surgical procedures such as implant exchange are not exclusionary.
* Patients on adjuvant hormone therapy for less than 1 month