cyrilzakka/clinical-trials huggingface dataset:
LUPUS-BEST - Treat-to-target in Systemic Lupus Erythematosus

Multicenter, national, two-armed cluster-randomized controlled trial to evaluate the effect of a treat-to-target (T2T) strategy in in systemic lupus erythematosus (SLE). 14 centers will be randomized 1:1 to T2T or standard of care. Per arm 303 patients with SLE who are not in remission will be included and receive either tight control with 6-weekly visits with the aim to reach remission or SoC with control visits and treatment adjustment according to the physicians discretion. Study duration is 120 weeks using damage accrual and Health related Quality of Life as major outcomes.

This is a multicenter, national, two-armed cluster-randomized controlled trial to evaluate the effect of a treat-to-target (T2T) strategy in in systemic lupus erythematosus (SLE) on damage progression and health related quality of life (HRQoL). The study centers will be assigned 1:1 to standard of care (SoC) or remission, defined as the absence of clinical disease activity (clinical SLEDAI =0) AND prednisolone ≤5mg/day AND physician global assessment (PGA) \<0.5 on a VAS 0-3. Patient with SLE \> 18 years of age who are not in remission will be eligible.

Per arm, 303 patients will be included. Intervention centers receive a standardized training on T2T and shared decision making (SDM). In the intervention centers, patients not on target enter a phase of tight control with 6-weekly visits and treatment adjustments (at least 4 visits) or until remission is reached and maintained. Patients in remission are reassessed every 12 weeks. In case of flare, they can re-enter tight control based on SDM. In the SoC arm, patients receive 3- to 6-monthly controls and treatment adjustments according to the physician's discretion. Study duration is 120 weeks using damage accrual and HRQoL as major outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Patients with SLE according to validated classification criteria
* Age at least 18 years
* Not in a stage of remission due to

  1. Clinical SLEDAI \> 0 AND/OR
  2. GC dosage above 5 mg prednisone equivalent per day AND/OR
  3. Physician global assessment ≥ 0.5 on a visual analogue scale (VAS) from 0 to 3
* Fluent German language skills
* Written informed consent

Exclusion Criteria:

* Participation in other interventional trial(s)
* Any disease or medical condition that, in the opinion of the investigator, would make the subject unsuitable for this study, would interfere with the interpretation of subject safety or study results, or is considered unsuitable by the investigator for any other reason. Examples could be:

  * Life-threatening SLE manifestations that require intensive care treatment
  * Active life-threatening diseases other than SLE
  * Active malignancies
  * Acute and chronic infections that do not allow the intensification of immunosuppressive treatment
Exploring the Influence of Sensory Cues on Eating Behavior Using Virtual Reality

Many factors influence eating choices among humans (mood, taste, convenience, time of day, etc.). Finding simple ways to decrease food intake or improve food choices could improve weight status and overall health of the general population. The purpose of this study is to see if city and/or nature smells affect human eating behavior within a virtual reality-simulated outdoor café. The researchers of this study believe that a better understanding of how smells affect eating behavior could lead to public guidelines that direct the construction and layout of such outdoor eating environments to better support healthy behaviors.


Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18-29
* Fluent in English
* Free of self-reported food allergies/food sensitivities
* No diagnosis of cognitive or physical disabilities/disorders that may affect appetite or eating behaviors (Examples include Major Depressive Disorder, dementia, or eating disorders)
* No diagnosis of disabilities that may affect sensory proprioception related to virtual reality (Examples include vertigo, epilepsy, and ataxia)
* Not color blind
* Does not experience anosmia (inability or weak ability to smell)
* Must have hair ≥3 cm in length at the cortisol sample site (roughly midline of the skull left to right and two inches up from the base of the hairline at the neck).
* No hair transplant in the last 6 months

Exclusion Criteria:

* Are younger than 18 or older than 29 years of age
* Not fluent in English
* Have self-reported food allergies
* Have a diagnosis of cognitive or physical disabilities that may affect appetite or eating behaviors (Examples include Major Depressive Disorder, dementia, or eating disorders)
* Have a diagnosis of disabilities that may affect sensory proprioception related to virtual reality (Examples include vertigo, epilepsy, and ataxia)
* Suffers from color blindness
* Suffers from anosmia (inability or weak ability to smell)
* Hair shorter than 3 cm in length at the cortisol sample site (roughly midline of the skull left to right and two inches up from the base of the hairline at the neck)
* Has had a hair transplant in the last 6 months
Study Comparing Total Extraperitoneal Patch "TEP" Versus Lichtenstein According Chronic Pain

The purpose of this study is to se if there is a difference regarding chronic pain and sexual dysfunction one and tree years after laparoscopic un fixated preperitoneal mesh versus gold standard open fixated on lay mesh in inguinal hernia surgery.

Long term cross-sectional follow-up comparing different instruments for measurement of chronic pain.

Prospective randomized study comparing total extraperitoneal patch TEP versus open onlay mesh according to Lichtenstein in primary unilateral inguinal hernias in men between 30 to 75 years of age. Non fixated polypropylene mesh is used in the TEP operation and fixated light weight polypropylene mesh is used in the Lichtenstein procedure. The aim is to study chronical pain and sexual dysfunction. Clinical examination according nerve function, hernia status and genital findings are performed together with a questionnaire including SF36, Inguinal Pain Questionnaire(IPQ), sexual function are registered preoperatively, one and tree years postoperatively.

Cross-sectional follow-up in median 7.5 years using enquiries for comparison of different pain instruments to evaluate the effect of chronic pain on physical activity.

Eligibility Criteria:
Inclusion Criteria:

* men between 30-75 years of age
* ASA class I-II
* primary unilateral inguinal hernia

Exclusion Criteria:

* lower midline incision below linea arcuate
* large scrotal hernia
* previously or current abuse,mental disease
* obesity BMI \> 35
* another simultaneous operation
* nonreducible hernia
* severe pain in the groin without nonrelated to hernia
* contraindications to general anesthesia
* need of language translator
* liver cirrhosis or ascites
* spread cancer disease
* previously irradiation in the area
* lack of operations indication
Optimising Renal Tumour Management Through Artificial Intelligence Modules

The goal of this observational study is to improve the management of people with renal tumour by multimodal artificial intelligence(AI). It will also measure the accuracy of the predictions from AI models. The main questions it aims to answer are:

1. whether the AI module can accurately provide tumor-related information such as Benign or malignant, subtypes, grading, stage, etc. by learning from preoperative CT images.
2. whether the AI module can help clinicians find out the most suitable surgical programme for people with renal tumor.
3. whether the AI module can integrate CT images and pathology slides, offering supplementary prognostic information to improve postoperative survival.

Participants who complete a CT(usually Contrast-enhanced CT, CECT) examination and undergo radical or partial nephrectomy will carry out active surveillance and record postoperative survival data for 5 years.

In this study, AI model will explore and clarify features in renal tumor CT images and pathological images that are difficult to detect manually, and then correlate them with clinical outcomes, thereby improving the diagnosis and treatment process for renal tumors. Firstly, the model can accurately distinguish renal tumor subtypes and predict stage, grade, and complexity so as to svoid misdiagnosis and assist clinicians in formulating treatment plans. Secondly, by learning from surgical videos, the model can provide additional information during surgerys, such as important anatomical landmarks, location of tumors. Finally, combining radiomics and pathomics, the model can differentiate between high-risk and low-risk patients after surgery, thus providing personalized prognostic guidance.

Eligibility Criteria:
Inclusion Criteria:

* Patients with renal tumor which can be treated by surgery;
* Complete CECT within 30 days before surgery;
* Patients who fully understand this study and sign the informed consent;

Exclusion Criteria:

* Patients with any item missing from the baseline clinical and pathological information;
* Patients who has already metastasized by the time the tumor is discovered;
* Previous treatment in any form, including surgery, targeted therapy and immunotherapy;
Australasian Resuscitation In Sepsis Evaluation Randomised Controlled Trial

The ARISE RCT is a multi-centre, randomised, controlled trial of EGDT compared to standard care in patients with severe sepsis presenting to the ED. The study will be conducted in multiple sites with 1600 patients enrolled into the study.

Hypothesis to be tested: EGDT, compared to standard Australasian resuscitation practice, reduces 90-day all-cause mortality in patients presenting to the ED with severe sepsis.

The primary aim of the study is to determine whether providing EGDT, compared to standard care, reduces 90-day mortality in patients presenting to the ED of hospitals in Australasia with severe sepsis.

Each patient meeting all of the exclusion criteria and none of the exclusion criteria will be randomised in the ED to receive either EGDT for a total of 6 hours post-randomisation, or standard care.

Patients assigned to receive EGDT will be cared for by the dedicated ARISE study team. The patient will receive treatment as per the study protocol for 6 hours with central blood oxygen levels as the target end-point, then receive standard care.

Patients assigned to receive standard care will continue to be cared for by the hospital team in accordance with current best practice.

Patients in both groups will also receive any additional treatment needed, such as antibiotics or surgery.

This study will involve 1600 patients with severe sepsis admitted to the ED from multiple hospitals.

Eligibility Criteria:
Inclusion Criteria:

* Suspected or confirmed infection
* The presence of TWO or MORE of the following SIRS criteria:

  * Core temperature \< 36.0 degC or \> 38.0 degC
  * Heart rate \> 90 beats/minute
  * Respiratory rate \> 20 breaths/minute or PaCO2 \< 32 mmHg or the requirement for mechanical ventilation for an acute process
  * White blood cell count \> 12.0 or \< 4.0 x109/L or \> 10% immature band forms
* Evidence of either refractory hypotension OR hypoperfusion:

  * Refractory hypotension is confirmed by the presence of a systolic blood pressure (SBP) \< 90 mmHg or mean arterial pressure (MAP) \< 65 mmHg after a 1000ml intravenous (IV) fluid challenge within 60 minutes (including IV fluids administered pre-hospital)
  * Hypoperfusion is confirmed by the presence of a blood lactate concentration greater than or equal to 4.0 mmol/L
* First dose of IV antimicrobial therapy commenced prior to randomisation

Exclusion Criteria:

* Age \< 18 years
* Contra-indication to superior vena cava (SVC) CVC insertion
* Contra-indication to blood products (e.g. Jehovah's Witness)
* Inability to commence delivery of the EGDT protocol within 1 hour of randomisation or complete 6 hours of EGDT
* Haemodynamic instability due to active bleeding
* Pregnancy (confirmed or suspected)
* In-patient transfer from another acute health care facility
* An underlying disease process with a life expectancy of \< 90 days
* Death is deemed imminent and inevitable
* A "limitation of therapy" order has been documented restricting implementation of the study protocol or the treating clinician deems aggressive care unsuitable
Effects of Preoperative Relaxation and Intensified Surgery Education in Patients Undergoing Herniotomy

This study aims to test the effects of a Preoperative Relaxation intervention and an Intensified Surgery Patient Education on pre- and postoperative wellbeing and health in Patients Undergoing Herniotomy.

see above

Eligibility Criteria:
Inclusion Criteria:

* referral for herniotomy
* preoperative anxiety at least 4/10 points on a numeric rating scale
* physical and mental capability to participant
* written informed consent

Exclusion Criteria:

* Emergency surgery
* malignoma
* recurrence of inaugural hernia
* severe comorbidity
* severy psychological disorders
* immunosuppression
* coagulation disorders
A Retrospective Review of Liver Resection Rate in Metastatic Colorectal Cancer Patients Following Downsizing Treatment With Chemotherapy Plus Cetuximab in Normal UK National Health Service Clinical Practice

This study is a multi-centre retrospective observational research study which will be conducted in UK centres with specialised liver surgical services.

The study will involve retrospective review of medical records of patients with metastatic colorectal cancer (mCRC) with metastases confined to the liver, defined locally as unresectable without downsizing therapy at first review by a Hepatobiliary Multi Disciplinary Team (HPB MDT). Erbitux is available for use in combination with chemotherapy as a downsizing treatment for patients with previously unresectable metastases.

The study aims to examine liver resection rates achieved in normal clinical practice in order to inform National Health Service (NHS) clinical and policy decision making and to further understanding of how cetuximab is used in a standard clinical setting. This study intends to estimate the proportion of patients with unresectable liver metastases who undergo liver resection following downsizing treatment with chemotherapy plus cetuximab.


Eligibility Criteria:
Inclusion Criteria:

* Patients who had mCRC and metastases confined to the liver
* Patients in whom downsizing regimens are recommended
* Patients in whom downsizing treatment included cetuximab
* Patients referred to Hepatobiliary Multi Disciplinary Team (HPB MDT) between 01.01.2010-31.03.2011

Exclusion Criteria:

* Patients who are considered to have immediately resectable liver metastases as determined by the HPB MDT
* Patients who are considered to have never resectable liver metastases as determined by the HPB MDT
* Patients who were aged less than 18 at date of initiation of cetuximab
* Patients who are enrolled in a clinical trial during the data collection period
* Patients who are receiving private healthcare for the treatment of mCRC
* According to Summary of Product Characteristics (SmPC)
Wear Experience With Daily Contact Lenses Over a Long Day

This study is evaluating the wear experience of a daily contact lens after 10, 12, 14, and 16 hours of lens wear.


Eligibility Criteria:
Inclusion Criteria:

* Must be a current spherical contact lens wearer with longs days of lens wear.
* Distance visual acuity of 20/25 or better with current contact lenses.
* Good general health (defined by medication use that has not changed within the last month and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the PI).
* Recent eye exam within the past year.
* Must have a working smart phone and be willing to download an app and/or receive and respond to texts.
* Ability to give informed consent.
* Willing to spend time for the study. Subjects will be required to attend three study visits, wear contact lenses on days between study visits, and must respond to push-notifications and/or texts on a smart phone for 5 days between visits 2 and 3.

Exclusion Criteria:

* No current ocular inflammation or infection as assessed by the study investigator.
Reducing Hepatitis C Virus (HCV)/Human Immunodeficient Virus (HIV) Risk Behaviors Among Injection Drug Users in China

The proposed study will investigate the knowledge level, attitudes, and perceptions among staff of Methadone Maintenance Treatment (MMT) clinics and intravenous drug users (IDUs) who attending MMT clinics, which is the most reachable population for HCV/HIV intervention in China. This study will also explore the barriers that prevent IDUs from getting HCV/HIV intervention/prevention and medical care services. This study will help to understand and address this important problem in China and other Asian countries.

The investigators propose to conduct 3 inter-related studies over 4 years using both qualitative and quantitative research methods to address a series of research questions. Firstly, The investigators will begin by assessing HCV/HIV knowledge, attitudes, perceptions, risk behaviors, and infection among IDUs in MMT clinics (Study 1) and HCV/HIV knowledge, attitudes, and HCV/HIV-related services among MMT staff (Study 2). Secondly, based on knowledge accumulated from Studies 1 \& 2; The investigators will adapt and develop HCV/HIV education materials appropriate for Chinese IDUs and drug treatment service providers, and then use the Transtheoretical Model of Behavior Change as a conceptual model to measure if our educational program will increase patients' readiness to consider changing HCV/HIV risk behaviors and getting medical care for HCV/HIV (Study 3). Finally, by integrating findings of these three studies and by consulting with leading experts in HCV/HIV. The investigators plan to develop HCV/HIV intervention program applicable in China, which can be tested in future formal experimental trials.

Eligibility Criteria:
Inclusion Criteria:

* several failed attempts to quit the use of heroin
* at least two terms in a detoxification center
* age at least 20 years
* being a registered local resident of the area in which the clinic is located
* being of good civil character

Exclusion Criteria:

* there is no exclusion criteria
Which Physical Therapy Program is Cost-effective in Knee Osteoarthritis?

Knee osteoarthritis (OA) is a disease with significant levels of socioeconomic burden to the society. P The non-pharmacologic interventions in knee OA include weight loss, exercise, and physical therapy. In this study, we aimed to to compare the cost-effectiveness of inpatient and outpatient physical therapy programs in patients with knee osteoarthritis.

Knee osteoarthritis (OA) is a major problem for society with a heavy economic burden. Especially in the elderly population, integrated rehabilitation programs are frequently used to improve patients' symptoms and quality of life. To estimate the costs and utility of the rehabilitation programs may help clinicians decide optimal treatment strategy with proper usage of resources. Therefore, we aimed to to compare the cost-effectiveness of inpatient and outpatient physical therapy programs in patients with knee osteoarthritis.The study included 52 patients with the diagnose of knee osteoarthritis. Patients were divided into two groups. Group 1 (n=30) received 21 sessions of inpatient physical therapy program including electrotherapy, superficial- deep heat applications and basic knee exercise program. Group 2 (n=22) received the same physical therapy program at outpatient clinic.

Eligibility Criteria:
Inclusion Criteria:

-Knee OA diagnosed patients based on American College of Rheumatology Criteria

Exclusion Criteria:

* visual disturbances
* malignancy
* inflammatory rheumatic diseases
* pregnancy
* advanced cardiovascular, kidney or liver pathologies
* uncontrolled hypertension
* patients who had injuries in their lower extremities
* patients who underwent under total hip or knee prosthetic surgeries.
GLYCAR Post Market Multicenter Study

Prospective, non-interventional, observational, multi-center, single arm, post market clinical follow-up study

This real-world, single-arm, multi-center, observational, non-interventional prospective registry will enroll up to 100 consecutive subjects undergoing cardiac and/or vascular repair or reconstruction surgery in 10-12 investigative sites in the European Union (EU), South Africa and USA. The study is aimed at providing real-world evidence of the Glycar Pericardial patch device performance and incidence of clinical outcomes in patients undergoing cardiac and/or vascular repair or reconstruction surgery related to Glycar Pericardial patch.

Eligibility Criteria:
Inclusion Criteria:

* Patients (to be) treated with Glycar Pericardial patch as per IFU and standard clinical practice.
* The patient or patient's legal representative signs an EC/ IRB approved informed consent form prior to the study participation

Intraprocedural inclusion:

GLYCAR Pericardial Patch was implanted, or implantation attempted during the index procedure.

Exclusion Criteria:

* No study specific exclusion criteria: patients treated per standard clinical practice and do not present any of the contraindications detailed in the IFU.
PrEP and Alcohol - Enhancing HIV Pre-Exposure Prophylaxis (PrEP)

The present investigation entails a pilot randomized controlled trial to explore whether a stand-alone, alcohol-reduction, brief intervention (with a module on substance use and depression) would be feasible, acceptable, and potentially efficacious within the context of HIV pre-exposure prophylaxis (PrEP) treatment.

Although HIV pre-exposure prophylaxis (PrEP) is an effective tool that can help prevent the acquisition of HIV, its degree of effectiveness has been shown to be linked to a number of key behaviors, including treatment adherence, attendance in follow-up care, and the concurrent use of condoms. Hazardous alcohol consumption has the potential to contribute to suboptimal PrEP adherence, poor retention in PrEP care, and condomless sex/sexually transmitted infections (STIs); and its impact on these PrEP-related behaviors may also become exacerbated in the presence of concurrent issues such as substance use and depression, thus reflecting a potential syndemic effect. The present investigation entails a pilot randomized controlled trial in which 120 hazardous drinking, PrEP-prescribed men who have sex with men (MSM) will be randomly assigned to receive either a tablet-based, alcohol-reduction brief intervention or treatment-as-usual. Participants assigned to the former condition for whom substance use- and/or depression-related concerns are identified will additionally be provided with links to relevant supportive resources. Feasibility and acceptability of the intervention will be examined. Furthermore, biomarker testing and self-report electronic surveys at baseline, 3-months, and 6-months will be employed to assess the preliminary impact of the intervention on alcohol use, PrEP adherence, retention in PrEP care, and the engagement in condomless sex/STI acquisition.

Eligibility Criteria:
Inclusion Criteria: Participants must be:

* aged 18 years or older,
* be a patient of Toronto General Hospital (TGH) or Maple Leaf Medical Clinic (MLMC),
* be a man who identifies as gay, bisexual, and/or a man who has sex with other men,
* have been prescribed PrEP for at least 3 months, and
* meet the criteria for hazardous drinking, (i.e., based on a score of ≥4 on the Alcohol Use Disorders Identification Test-Consumption measures (AUDIT-C)).

Exclusion Criteria:

* Participants will be excluded if they do not meet all of the above-mentioned inclusion criteria.