cyrilzakka/clinical-trials huggingface dataset:
MR- PET Guided Biologically Optimised Interstitial Brachytherapy

The proposed two stage study will evaluate patterns of local recurrence after EBRT and brachytherapy in spatial reference to baseline functional MRI and FLT/F-Miso PET scan in patients undergoing chemoradiotherapy for postoperative recurrences of cervical cancer. The first stage of the study will focus on developing MR guided interstitial brachytherapy and validating the concept of high risk gross tumor volume (on the basis of functional imaging features).

The second stage thereafter will focus on developing biologically modulated interstitial brachytherapy.

In the proposed two staged study the investigators intend to prospectively evaluate and validate concept of HRGTV and develop technique of biologically dose modulated brachytherapy. The demonstration of technical feasibility and clinical safety of biologically modulated image guided radiotherapy in this pilot study for may pave the way for improving local control in patients with postoperative recurrences.

Aims

Stage I

Aim 1: To spatially characterize biologically heterogenous subvolumes within the gross tumor through multimodality (18 F-Miso/FLT/Functional MR) image fusion.

Aim 2: To evaluate post external beam radiotherapy (EBRT) response in spatial reference to biological heterogeneous sub-volumes on imaging.

Stage II:

Aim 3: To evaluate technical feasibility of delivering dose modulated biologically optimized interstitial brachytherapy.

Aim 4: To evaluate acute and late toxicity and quality of life associated with biologically optimized brachytherapy

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years.
* ECOG 0 or 1.
* Residual/ Recurrent tumor after hysterectomy of cervical cancer.
* No visceral metastasis.
* No known contraindication to contrast enhanced MRI/PET scan.
* Fit for radical treatment (radiotherapy+/-chemotherapy).

Exclusion Criteria:

* Expected survival less than 3 years due to coexisting morbid medical conditions precluding radical chemoradiotherapy.
* Inguinal or extra-pelvic nodal metastasis (Patients with common iliac nodal enlargement in the absence of paraaortic nodal metastasis on PET-CT may be included in the study).
The Effect of Reflexology on Pain, Comfort and Breastfeeding Self-Efficacy

This study was conducted to determine the effects of reflexology applied to mothers with headache due to spinal anesthesia after Cesarean delivery on pain, comfort and breastfeeding self-efficacy levels. The study, which was conducted with a single-blind, randomized controlled experimental design, was conducted between April 2024 and August 2024 at the Department of Obstetrics and Pediatrics, SBU Van Training and Research Hospital with mothers who had cesarean delivery under spinal anesthesia and had postpartum headache (Intervention group=30, Control group=30). Foot reflexology was applied to the mothers in the intervention group for a total of 30 minutes, 15 minutes on each foot. The control group was not subjected to any intervention other than routine nursing practices. Personal Information Form, Visual Analog Scale (VAS), Postpartum Comfort Scale (PPSC) and Breastfeeding Self-Efficacy Scale (BSSE) were used as data collection tools.


Eligibility Criteria:
Inclusion Criteria:

* 18 years and older,
* performing SD under spinal anesthesia,
* experiencing postpartum headaches,
* Caesarean section performed at 37-42 weeks of gestation,
* giving only one live birth,
* open to written or oral communication,
* at least a primary school graduate,
* no complications during pregnancy,
* mothers who agreed to participate in the study

Exclusion Criteria:

* Performing a cesarean section at periods other than 37-42 weeks of gestation,
* caesarean section under general anesthesia,
* have health problems such as fractures, dislocations, phlebitis, arthritis, burns, wounds, eczema, fungus or inflammation in the foot tissue,
* with disease of the cardiovascular system,
* with chronic diseases such as hypertension or diabetes mellitus,
* Postpartum controlled analgesia administered,
* mothers with psychiatric diagnoses such as anxiety and depression
O2matic Cardiology Protocol

Automatic oxygen supply with the O2matic device has been shown to provided an enhanced oxygen treatment in patients with hypoxemia. O2matic was significantly better than manual control to maintain oxygen saturation within target interval and to reduce time with unintended hypoxemia in patients suffering from chronic obstructive pulmonary disease. This trial investigates the effect of using O2matic in hypoxic patients submitted to the Department of Cardiology.

Oxygen supply to patients with cardiovascular disease has been subject to several investigations. Both too much and too little oxygen is supposed to be harmful. The O2matic device is a new way of supplying oxygen treatment which is significantly better than manual control to maintain oxygen saturation within target interval and to reduce time with unintended hypoxemia. The device has past favorable tests in patients suffering from chronic obstructive pulmonary disease. This study investigates the application of the O2matic device on hypoxic patients admitted to the Cardiology ward.

Eligibility Criteria:
Inclusion Criteria:

* Patients with heart disease and an oxygen saturation below 94% admitted to the Department of Cardiology
* Age of 30 or more
* Intellectual capacity to participate in the trial
* Willing to give informed accept of participation in the trial.

Exclusion Criteria:

* Unstable patients
* Need for ventilatory support except intermittent continuous positive airway pressure
* Fertile women (age\<55 years) with a positive pregnancy test
* Unable to participate due to language or cognitive problems
A Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of Subjects With Plaque Psoriasis

A Multi-Center, Open-Label, Phase 2 Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of ADX-629 Administered Orally to Subjects with Plaque Psoriasis


Eligibility Criteria:
Inclusion Criteria:

* Subject is a male or non-pregnant female 18 years of age or older.
* Subject has provided written informed consent.
* Females must be post-menopausal, surgically sterile, or use a highly effective method of birth control during the trial and for 30 days after the last administration of test article. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test (UPT) at Visit 1/Screening and Visit 2/Baseline.
* Male subjects who are not surgically sterile (e.g., vasectomy performed at least 6 months prior to trial entry) and are sexually active with a female partner who is of childbearing potential must agree to use an effective form of birth control for the duration of the trial and for 90 days after completion of treatment.
* Subject, in the investigator's opinion, is in good general health and free of any disease state or physical condition that might impair evaluation of plaque psoriasis or exposes the subject to an unacceptable risk by trial participation.

Exclusion Criteria:

* Subject is pregnant, lactating, or is planning to become pregnant during the trial.
* Subject has a physical condition which, in the investigator's opinion, might impair evaluation of plaque psoriasis or which exposes the subject to an unacceptable risk by trial participation.
* Subject is currently enrolled in an investigational drug, biologic, or device trial.
* Subject has used an investigational drug, investigational biologic, or investigational device treatment within 30 days prior to Visit 2/Baseline.
Comparison of Intermittent Oro-Esophageal Tube Feeding in Infants With Cerebral Palsy and Dysphagia

This was a randomized controlled study including 80 infants with cerebral palsy and dysphagia. The Participants were evenly divided into the observation group (with intermittent oro-esophageal tube feeding, n=40) and the control group (with persistent nasogastric tube feeding , n=40). Nutritional status and physical development, condition of dysphagia, and pneumonia before and after 3-month treatment were compared.

In China, for nutrition support in the infants under one year of age with cerebral palsy and dysphagia, persistent nasogastric tube feeding is the mainstream choice. However, the efficacy of persistent nasogastric tube feeding is not sufficiently satisfactory, necessitating the exploration for a more effective and safe nutrition support approach. Therefore, this study reports the clinical effect of intermittent oro-esophageal tube feeding compared to persistent nasogastric tube feeding in the infants with cerebral palsy and dysphagia who received systemic therapy.

Method This was a randomized controlled study including 80 infants with cerebral palsy and dysphagia. The Participants were evenly divided into the observation group (with intermittent oro-esophageal tube feeding, n=40) and the control group (with persistent nasogastric tube feeding, n=40). Nutritional status and physical development, condition of dysphagia, and pneumonia before and after 3-month treatment were compared.

Eligibility Criteria:
Inclusion Criteria:

* meeting the diagnostic criteria of cerebral palsy formulated by the 13th National Conference on Pediatric Cerebral Palsy Rehabilitation;
* age\<1 year;
* diagnosed as dysphagia confirmed by Dysphagia Disorder Survey or pediatric esophagoscopy;
* with a nasogastric tube inserted at admission;
* enteral nutrition support is required and feasible.

Exclusion Criteria:

* with dysphagia caused by other diseases or factors;
* with progressive neurological disease or degenerative neurological disease;
* with severe heart disease, liver or kidney dysfunction, hematological disorders, or other acute and severe symptoms;
* with abnormalities in the oral cavity, pharynx, esophagus, or other parts of the digestive tract;
* with poor compliance.
The Radium-select Study

Radium-223 is an established radionuclide therapy for patients with metastatic castration resistant prostate cancer (mCRPC) and symptomatic bone metastasis. Patients are eligible for this treatment when they have mCRPC and bone metastases; limited extraskeletal lesions (local prostate, lymph nodes \<3 cm) on conventional contrast enhanced CT (ceCT) were allowed in the registration trial(1). Previous research revealed that extraskeletal disease on ceCT and bone scans correlates with a poor response. Meanwhile, 68Ga-PSMA-PET/CT emerged as more sensitive imaging strategy that increases the detection of extraskeletal prostate cancer metastases. It is unclear whether these extraskeletal lesions harbour any predictive value in the treatment of mCRPC patients with Radium-223.

Study design:

The investigators will conduct a prospective clinical study in which patients with mCRPC and bone-only disease according to ceCT and bone scan will receive standard-of-care treatment with Radium-223. In addition to standard-of-care systemic treatment, each patient will undergo an additional 68Ga-PSMA-PET/CT scan at baseline and will be followed throughout the treatment with patient reported outcome measure (PROM) questionnaires (Kaiku application) and blood sampling for circulating tumor DNA (ctDNA) analysis. The treating physicians will be blinded to the result of the baseline 68Ga-PSMA-PET/CT scan. Each patient will receive a maximum number of 6 cycles of Radium-223 therapy according to current clinical guidelines and will undergo response evaluation by ceCT and bone scans upon clinical progression. At clinical progression, each patient will undergo a second 68Ga-PSMA-PET/CT to determine the location of disease progression and assess the value of 68Ga-PSMA-PET/CT imaging as a response measure. The clinical response of Radium-223 therapy in the patients with bone-only disease according to 68Ga-PSMA-PET/CT scanning, will be compared to the treatment outcomes collected in our previously reported ROTOR registry. Secondary aims are to determine the value of ctDNA as predictive biomarker and the value of 68Ga-PSMA-PET/CT imaging in the response assessment.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the prostate.
* Progressive disease after previous treatment defined as a rise in serum (Prostate Specific Antigen) PSA (PCWG3 criteria(22), see appendix 1) and/or progression on conventional imaging (PCWG3).
* A positive bone scan (osteoblastic bone metastases), with at least two metastases.
* Hemoglobin concentration \>10 g/dl (6.2 mmol/l) and thrombocytes \>100 109/I at baseline.
* Each patient will need to (continue to) receive adequate bone protective agents (e.g. bisphosphonates) and androgen deprivation therapy (ADT) according to current clinical guidelines.

Exclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance score \>2
* Life expectancy \< 6 months.
* Detected extra-skeletal metastases or lymph node metastases (\>3 cm short axis) as identified by conventional imaging (ceCT thorax/abdomen)
A Chatbot to Support Substance Use Recovery

The goal of this clinical trial is to learn if/how an AI chatbot can support patients who in recovery for substance use, specifically those who are receiving medication for opioid use disorder.

Can the chatbot help lower drug use? Can the chatbot help improve clinical appointment adherence? Can the chatbot help patients build self-efficacy in leading their own recovery journey? Will the chatbot help reduce workload burden for primary care teams? Can the chatbot serve as a safe, useful and engaging tool to support patients?

Researchers will investigate the effects of using a chatbot to support follow-up care for patients in opioid use recovery.

Participants will:

* Receive access to a chatbot for 12 weeks that they can use to prepare for upcoming clinical appointments, find community resources, learn about urge-surfing and wellness techniques, and query for assistance with other recovery-related information and tasks
* Complete surveys and provide user feedback


Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old
* Comfortable with reading, understanding, and communicating in English
* Receiving medication treatment for OUD at MGH?
* Able to participate in a remote interview?
* Own or have reliable access to Wi-Fi or a cellular network
* Willing to use a mobile device to access the chatbot?

Exclusion Criteria:

* Has any cognitive, visual, or auditory impairments that may prevent the participant from using the chatbot on a mobile device?
* Unstable medical condition that compromises the ability to safely participate
A Study Evaluating the Perception of Insertion Pain With Accu-Chek FlexLink and FlexLink Plus Insulin Pump Devices Under Real Life Conditions in Diabetic Patients.

German Multi-centered, randomized, crossover study in diabetic patients evaluating two infusion sets under real life conditions at home. Subjects will be randomized to use one of the infusion set devices during the first period of 4 weeks, and be switched to the other infusion set for the second period of 4 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects at least 18 years of age
* Diabetes mellitus type 1 or type 2
* Continuous subcutaneous insulin therapy (CSII) for at least 3 months
* Insulin pump compatible with Luer lock infusion set (Accu-Chek, Disetronic, Animas, Deltec Cozmo and Minimed 506 to 508)
* Sufficient potential infusion sites suitable for the usage of a cannula length of 8 mm and a tubing length of 70 and 80 cm
* Willing to measure blood glucose at least 4 times per day and 1-3 hrs after each new insertion
* Willing and able to participate and comply with study procedures including the general recommendation of shifting infusion sets (at least every 3 days)

Exclusion Criteria:

* Significantly impaired awareness of hypoglycemia
* A history of or high risk of ketoacidosis during CSII therapy
* Frequent catheter abscesses in the past year, as per investigator´s discretion
* Known strong plaster incompatibility and/or allergy (history of catheter use)
* Unstable chronic disease other than diabetes
* Chronic use of steroids in adrenal suppressive doses, other immuno-modulatory medication or chemotherapy
* Acute illness or abnormality at the time of screening rendering the patient not suitable to participate in the study in the opinion of the Investigator
* Chronic use of analgesics and any other condition interfering with the assessment of pain, as per investigator´s discretion
* Are either pregnant or breastfeeding or are currently planning a pregnancy
Impact on Quality of Hospital Care During Pre- and Post- Rotavirus (RV) Vaccination Introduction in Belgium

This study aims to investigate whether a change in the pattern of hospitalisation was observed in paediatric wards over the last 6 years (June 2004 - May 2010), whether a change in staff workforce availability was observed in paediatric wards over the last 6 years (during a whole year or during specific time periods of the year) and if changes of any of the variables measured during the observation period could be linked to the introduction of rotavirus vaccination.

This retrospective study will use data extracted from hospital databases during the period of the 1st of June 2004 until the 31st of May 2010. A coded list of all hospitalisations and of the different infection tests performed in children will be generated, together with a list of Full time equivalents (FTE) in paediatric ward and the number of sick leave days of the working personnel.

Eligibility Criteria:
Inclusion Criteria:

* All children aged ≤15 years being hospitalised (with overnight stay or day clinic) for whatever reason during the study period

Exclusion Criteria:

* Not Applicable
Microcirculation in Cardiogenic Shock

Cardiogenic shock is usually defined as primary cardiac dysfunction with low cardiac output leading to critical organ hypo perfusion and tissue hypoxia. Despite progress in the management of cardiogenic shock, mortality remains unacceptably high.

This significant mortality, close to 40 %, is partly due to profound alterations of microcirculatory blood flow in cardiogenic shock, leading to multi organ failure, despite restoration of macro-hemodynamic parameters such as blood pressure and cardiac output. The microcirculation is the terminal vascular network of the systemic circulation consisting of microvessels with diameters \< 20 μm including arterioles, capillaries, and venules. This part of the circulation is critical as it is responsible for nutrient delivering and oxygen transfer from the erythrocytes in the capillaries to the parenchymal cells to meet their metabolic demands, but it is also the area where water, other gases, hormones and waste products are exchanged.

Hence, the evaluation of clinical signs of peripheral hypoperfusion reflecting microvascular perfusion is of interest. We aimed to study these parameters such as skin capillary refill time (CRT), mottling and central-to-toe temperature difference (ΔTc-p) in a cardiogenic shock population. Assessing the prognosis of these microcirculation parameters and their interaction with macrocirculation parameters such as arterial pressure, cardiac index, left ventricular ejection fraction is also the aim of this study. Lastly, looking at the prognostic value of these markers seems interesting.


Eligibility Criteria:
Inclusion Criteria:

* major patient (≥18 years old)
* Patient with a cardiogenic shock table defined by the association of low cardiac output even though the filling pressures are normal or high, causing hypoperfusion and organ pain
* patient affiliated to a social security scheme
* patient (or family member / trusted or close) who has agreed to participate in the study

Exclusion Criteria:

* refusal of the patient to participate in the study
* patients with dark skin preventing the evaluation of clinical markers of microcirculation.
* subject under the protection of justice
* subject under guardianship or curatorship
Risk Evaluation by COronary CTA and Artificial IntelliGence Based fuNctIonal analyZing tEchniques - II

This study is a multicenter, prospective clinical cohort study. The study intends to continuously enroll patients with coronary heart disease. All subjects will undergo coronary CTA (followed by anatomic, functional and radiomics analysis), proteomics research as well as clinical follow-up of cardiovascular events. The purpose of this study is to establish a new, non-invasive cardiovascular disease risk stratification system.

Coronary angiography has been the gold standard for the diagnosis of coronary heart disease and PCI decision-making. However, the value of CAG in risk stratification is limited due to its invasive nature and lack of ability to evaluate coronary physiology and plaque characteristics, which often leads to over-treatment or under-treatment. In recent years, with the development and improvement of imaging technology, the resolution and diagnostic accuracy of coronary artery CTA have been greatly improved, and the subsequent anatomy and function (non-invasive CT-FFR, etc.) have made the assessment of coronary artery lesion risk multi-dimensional. Comprehensive and accurate coronary artery CTA scan plays a positive role in establishing the appropriate standard for PCI and improving the prognosis of patients. However, the existing problems of coronary artery CTA are insufficient imaging studies, complex image analysis, inconsistent diagnostic criteria, and insufficient clinical evidence. This study is one of the series of clinical studies on the topic of "Risk Evaluation by COronary Computed Tomography and Artificial Intelligence Based fuNctIonal analyZing tEchniques (RECOGNIZE)". The purpose of the study is to evaluate the accuracy of early identification of cardiovascular high-risk groups based on the functional evaluation model based on coronary CTA images through a multi-center, prospective clinical cohort study, so as to establish an early, non-invasive and accurate risk classification of cardiovascular events in coronary heart disease.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years
* Clinically significant angina pectoris, suspecting coronary artery disease

Exclusion Criteria:

* Unsuitable for coronary CTA (such as severe renal impairment, uncontrolled thyroid condition, allergic to iodine, etc.)
* Without a visible plaque (defined as ≥ 30% stenosis) in major coronary arteries in coronary CTA
* Prior history of myocardial infarction or heart failure
* Prior history of percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)
* Severe renal or liver failure
* Familial hypercholesterolemia
* Estimated survival ≤1 year
* Malignant tumor
* Poor coordinance, unable to follow-up