cyrilzakka/clinical-trials huggingface dataset:
Transcatheter Microguidewire Drilling for Transseptal Left Atrial Access

This study aims to investigate the safety and efficacy of transcatheter microguidewire drilling (TMD) for transseptal left atrial access in patients with abnormal atrial septal morphology.

Despite the widespread application and decades of experience, Brockenbrough-needle transseptal puncture still risks cardiac perforations and secondary pericardial effusion/tamponade, especially in patients with abnormal atrial septal morphology. To facilitate atrial septal crossing, different methods and devices have been developed, including radiofrequency energy, excimer laser, SafeSept wire and so on. However, these are still limited by availability and cost, and the advantages might be further offset by the potential risks. In addition, these methods are performed mainly with the linear insertion technique, which might result in less forward-force to penetrate atrial septum and displacement of needle-tip. Therefore, it is necessary to develop a safe, available and low-cost transseptal procedure for these patients.

Through a Brockenbrough needle, the hard "back-end" of the microguidewire (0.014-inch) has the potential to drill through the atrial septum with ease. Compared with a standard linear insertion technique, the penetration might be improved and less force is required with the bidirectional rotation technique, and the related risks might be reduced with the modified TSP due to the thin microguidewire. After the passage of the needle, the soft-end of microguidewire can be introduced into left pulmonary superior vein, which can become a safe rail for the introduction of puncture dilator/sheath.

In this study, we examined the effectiveness and safety of microguidewire-assisted TSP for patients with complex atrial septum.

Eligibility Criteria:
Inclusion Criteria: 1) Patients with atrial septal aneurysm (a bulging of the atrial septum of at least 10 mm beyond the plane of the atrial septum into either the right or left atrium); 2) Or patients with previous multiple transseptal punctures (≧2); 3) Or patients with thickened atrial septum (thickness ≧3 mm); 4) Or patients with enlarged right atrium (≧ 6 cm) and diminished left atrium (\< 3 cm); 5) Or patients with prior mitral valve surgery; 6) Or patients with atrial baffles.

Exclusion Criteria: 1) Associated atrial septal defect or patent foramen ovale; 2) Associated interrupted inferior vena cava; 3) Presence of implanted cardiac devices; 4) Echocardiographic evidence of intracardiac thrombus, mass, tumor or vegetation; 5) Thromboembolic events within the last 6 months; 6) Patients unable to grant informed, written consent.
Postprandial Profiles of Metabolites and Appetite-regulating Hormones in Plasma and Cerebrospinal Fluid

Overweight and obesity are rising in prevalence and becoming a growing threat to public health. Obesity is associated with an increased all-cause mortality, impaired quality of life, and numerous of disorders. Therapeutic strategies against obesity - which include an abundance of dietary and physical training programmes and pharmaceutical drugs to increase energy expenditure or limit appetite or gastro-intestinal fat absorption - have shown limited success on long term weight loss. Thus, overweight and associated conditions is becoming the new normal and there is a need for better understanding gut-to-brain signalling, hormonal and metabolic disturbances in overweight individuals.

The purpose of this health science research project is to describe the coinciding plasma and cerebrospinal fluid (CSF) profiles of selected biomarkers after co-ingestion of a meal and model pharmaceuticals in patients with overweight and/or type 2 diabetes compared to healthy control individuals.


Eligibility Criteria:
Inclusion Criteria:

* 10 male patients with obesity (BMI \>30) and type 2 diabetes
* 10 male volunteers with normal weight (BMI 20-24) matched by age
* 10 male volunteers with obesity (BMI \>30) matched by age

Exclusion Criteria:

1. Unwillingness to participate or wish to withdraw from ongoing protocol
2. Hepatic disease or hemorrhagic diatheses (including abnormal International Normalized Ratio (INR), bilirubin, blood levels of thrombocytes, alanine-aminotransferase (ALAT))
3. Anticoagulant treatment (e.g. treatment with warfarin, apixaban or another oral anticoagulant)
4. Anaemia (p-hemoglobin below normal range)
5. Nephropathy (se-creatinine \>130 μM and/or albuminuria)
6. Suspected difficult access to the spinal canal (e.g. pronounced scoliosis, spinal stenosis, osteoporotic coincidence in the lower back, spina bifida, meningocele after surgical intervention)
7. Lumbar skin infection (e.g. herpes zoster, pustules or ulcers)
8. Medical history with headaches - both in connection with dura puncture and frequent headaches of other types
9. Central nervous system disease (including dementia, previous stroke, multiple sclerosis, epilepsy, etc.)
10. Clinical suspicion of increased intracranial pressure (headaches, visual disturbances etc.)
11. Patients with type 2 diabetes: Treatment with DPP-4 inhibitor or GLP-1 receptor agonist. Late diabetic complications including proliferative diabetic retinopathy (anamnestic), arteriosclerotic cardiovascular disease (heart failure or previous ischemic event/myocardial infarction)
Effects of Acute Hypobaric Hypoxia Exposure on Neurocognitive Performance of Pre-hospital Emergency Service Providers

The study aims to evaluate the effects of acute hypobaric hypoxia on cognitive performance (H0: cognitive performance at 200 meters above sea level (asl) = cognitive performance at 3000 meters above sea level = cognitive performance at 5000 meters above sea level).

Before participating in the study, each participant will respond to a questionnaire related to high altitude exposure (prior 3 months), as well as inclusion/exclusion criteria evaluation.

On day 0, after the interview and signed informed consent, the participant will undergo a medical examination that will include a general objective examination. Participants will participate in a training on the emergency and safety procedures of the hypobaric hypoxia facility, as well as a refresh on cardiopulmonary resuscitation procedure.

During the following two days (day 1 and 2) the study protocol will be executed (one test per day). The study protocol envisages:

* a basal cognitive test battery
* blind ascent in the hypobaric chamber to simulated altitude
* cognitive test battery
* 5 minutes of recorded chest compressions on dummies
* cognitive test battery
* blind descent in the hypobaric chamber.

During the stay in the hypobaric hypoxic facility, each participant will be monitored in real time with the Equivital© medical monitoring device.

Before and after the stay in the hypobaric hypoxic facility, a saliva sample will be collected, and psychological tests administered.


Eligibility Criteria:
Inclusion criteria:

* Healthy volunteers
* Age 18-60 yr-old
* ASA class I
* Signed informed consent

Exclusion criteria:

* Age \<18 or \>60 yr-old
* ASA class \> I
* Informed consent not signed
Low-Molecular-Weight Heparin (LMWH) for Deep Venous Thrombosis (DVT) Prophylaxis

1. The use of LMWH following open reduction and internal fixation of ankle fractures will reduce the number of thrombi formed.
2. The rates of clinically significant DVT will be equivalent between two groups.

Routine use of thromboprophylaxis may be over treatment and definitely increases healthcare costs. While prophylaxis may reduce the number of thrombi formed the exact number and clinical significance of these is unknown. This study seeks to answer the question of whether or not DVT prophylaxis with low-molecular-weight heparin (LMWH) following ORIF of ankle fractures is warranted.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Surgical ankle fracture able to be definitively treated with one operation

Exclusion Criteria:

* Younger than 18 years of age
* Other significant injury
* Known hypercoagulable state
* History of bleeding disorder
* History of DVT
A Phase 1/2 Study of Personalized PSMA Radiopharmaceutical Therapy

The goal of this clinical trial is to study a personalized regime of lutetium-177 (177Lu) prostate-specific membrane antigen (PSMA) radiopharmaceutical therapy (RPT) in patients with progressive and/or symptomatic, inoperable PSMA-expressing cancers of prostatic or other origins.

The main questions it aims to answer are:

* To establish a dosimetry-based, personalized regime of 177Lu-PSMA
* To report on the efficacy of personalized 177Lu-PSMA

Participants (stratified by risk factors of toxicity) will receive up to 6 cycles of a personalized activity of 177Lu-PSMA based on renal dosimetry. In the phase 1, the prescribed absorbed dose to the kidney will be escalated, to determine the regime that will be administered in the phase 2. The best response within 12 months after the first cycle will be assessed. Salvage treatment of 3 cycles may be offered to responders after re-progression.


Eligibility Criteria:
Inclusion Criteria:

* \>18 y.o. adults able to provide consent
* Inoperable or metastatic PSMA-expressing cancer, with significant PSMA expression defined as uptake in at least one lesion that is superior to that of the liver on PSMA positron-emission tomography (PET) within 3 months prior to enrolment
* Cancer progression documented within 3 months prior to enrolment as per the investigator's assessment, without initiation of another anti-cancer treatment since (excluding palliative radiation therapy to a minority of the tumor burden), unless that anti-cancer treatment was stopped prematurely because of intolerance
* For participants with a cancer other than mCRPC, a recommendation from a multidisciplinary tumor board (MDT) in favor of PSMA RPT must be obtained

Exclusion Criteria:

* Platelets \< 50 x 106/L
* Absolute neutrophil count (ANC) \< 1.0 x 106/L
* Eastern Cooperative Oncology Group (ECOG) 4 or prognosis \< 3 months, for cancer-related or other serious medical conditions, as per investigator's assessment
* Known presence of central nervous system metastasis at risk of complication, which cannot be adequately stabilized (e.g. radiotherapy or corticoid prophylaxis), as per investigator's assessment
* Any condition that would limit the ability to comply with the study protocol, as per investigator's assessment
* Pregnancy or breastfeeding (e.g. for female participants with non-prostate cancer)
Transfer From a Point-of-care Ultrasound Course

This study explores the effect of a four-hour ultrasound course on physicians' point-of-care ultrasound performance on patients representing acute abdominal surgical conditions.

A randomized controlled trial with physicians was conducted. The intervention group participated in a four-hour abdominal POC US course before performing ultrasound on four patients with different abdominal surgical conditions. The control group did not participate in a course before performing ultrasound on the patients.

Eligibility Criteria:
Inclusion Criteria:

* Medical Doctor
* Signed up for a courses in abdominal point-of-care ultrasound

Exclusion Criteria:

* None
Enhancing Everyday Autonomy for People With Dementia

Dementia is a highly disabling major neurocognitive disorder. Although cognitive symptoms drive the diagnosis of dementia, neuropsychiatric symptoms (NPS), such as agitation, aggression, and psychosis, are common and associated with increased morbidity/mortality, increased care partner distress, and earlier institutionalization. Although these symptoms are debilitating and experienced by more than 90% of people with dementia, there are currently no FDA-approved treatments. There remains a critical need for safe and effective interventions for NPS that can be easily administered and monitored in typical clinical settings.

One hypothesis for the etiology of NPS is that, as cognitive impairment progresses, there is a decline in the sense of autonomy and an increase in unmet needs that a person with dementia (PWD) is unable to meet on his/her own and that care partners lack the knowledge or ability to meet. As care partners become increasingly involved as surrogate decision-makers for a PWD, the quality of life for a PWD is directly impacted by the decisions made by a surrogate. Several studies have explored agreement between PWDs and surrogate decision-makers regarding various preferences. Results have indicated that discrepancy between a PWD's preferences and those identified by a surrogate decision-maker is common.

According to our conceptual model, such discrepancy may give rise to NPS. Thus, the proposed pilot project directly addresses major gaps in the availability of safe, effective, and accessible strategies to reduce NPS and NPS-related care partner distress by developing and testing a novel educational intervention that directly targets discrepancies regarding everyday preferences. We will randomize 30 dyads comprising people with clinically significant cognitive impairment (mild cognitive impairment or dementia) and their care partners. The dyads will be randomized to either 1) the intervention arm in which there is a clinician-facilitated discussion between the dyad pair about NPS, the unmet needs hypothesis, and areas of discrepancy in everyday preferences and 2) the enhanced usual care arm in which a standardized document describing NPS and the unmet needs hypothesis will be given to the dyad to review. Primary efficacy will be measured by the Neuropsychiatric Inventory brief questionnaire form (NPI-Q), which allows for assessment of both NPS burden as well as burden of caregiver stress. Assessments will be made at baseline, week 4, and week 8.


Eligibility Criteria:
Inclusion Criteria:

* Individuals who are 55 years or older with a diagnosis of MCI (mild cognitive impairment) or mild to moderate dementia will be eligible (Montreal Cognitive Assessment Score, MoCA, \> 10).
* Evidence of neuropsychiatric symptoms of dementia (NPI-Q score \> 1).
* People with cognitive impairment must have an identified care partner: a family member, close friend, or caregiver who knows the person well with contact at least three times/week.

Exclusion Criteria:

* None.
Cancer: Thriving and Surviving Online Workshop and Study for Cancer Survivors

Cancer: Surviving and Thriving is a 6-week workshop for cancer survivors. The overall goal of the study is to determine whether an online cancer survivor education and support workshop can have lasting beneficial effects in helping survivors improve their self-management of health skills and quality of life.

This workshop is aimed at helping you better manage your own health and the demands placed on you because of your cancer diagnosis. It is hoped that the workshop will give you the skills needed to reduce stress and improve your quality of life. If successful, the workshop can be made available to other cancer survivors.

Each workshop is 6 weeks with new lessons each week. You will be asked to log on at your convenience 2-3 times each week for a total of 1-2 hours, to read the lessons, complete assignments, and share your ideas and experiences with your classmates. There are no requirements that participants log in at the same time.

With the moderators and other workshop participants, you will discuss:

* Healthy eating
* Managing fatigue
* Managing stress
* Starting and maintaining an appropriate physical activity program
* Getting a good night's sleep
* Dealing with difficult emotions
* Solving the problems caused by having had cancer
* Communicating better with your health care professionals
* Communicating better with your friends, family and coworkers

Eligibility Criteria:
Inclusion Criteria:Any adult (19 and over) cancer survivor living in the United States who: 1) was diagnosed within the past 5 years with a new or recurring cancer since the original diagnosis; 2) has completed their cancer treatment (surgery, radiation and/or chemotherapy); 3) isn't currently being treated for cancer except for hormonal therapy; and 4) has and email account and access to high speed internet connection. Exclusion Criteria:Not meeting the inclusion criteria
Early Interim 18F-FDG-PET and 18F-FLT-PET for Predicting Treatment Response and Survival in Metastatic Breast Cancer

We aim to investigate the value of 3'-deoxy-3'-18F-fluorothymidine (18F-FLT) and 18F-fluorodeoxyglucose (18F-FDG) positron emission tomography/computed tomography (PET/CT) for early prediction of treatment response and survival in patients with metastatic breast cancer after salvage therapy.

Patients with metastatic breast cancer were enrolled and received PET/CT using 18F-FLT and 18F-FDG at baseline, after 1st cycle , and after 2nd cycle of systemic chemotherapy. The standard reference for treatment response was classified according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria for contrast-enhanced CT (CE-CT) after 3 months of systemic chemotherapy. The metabolic response on PET was assessed according to PET response criteria in solid tumors (PERCIST) criteria and was correlated to the treatment response, progression-free survival (PFS), and overall survival (OS).

Eligibility Criteria:
Inclusion Criteria:

* Participants must have histological evidence of breast cancer of any stage
* Participants must be diagnosed with metastatic breast cancer
* Participants should be willing and able to have both PET-CT scans
* Participants should be eligible for and plan to undergo systemic chemotherapy and should be seen by a oncologist prior to beginning the study
* Participants should have the ability to understand and the willingness to sign a written informed consent document
* Participants must sign a study specific consent form prior to registration

Exclusion Criteria:

* Patients have been diagnosed with other malignancy
* Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or significant inflammation at treatment site or psychiatric illness/social situations that would limit compliance with study requirements or whose lab values do not meet the criteria above are excluded
* Pregnant women are excluded from this study
* Breast feeding women are excluded from this study
Intra-Articular Platelet Rich Plasm Use in Osteoarthritis of Knee.

Osteoarthritis of the knee is a very prevalent disease. However, there are few therapeutic options for its patients. Platelet-rich plasma is a treatment option for chronic pain. If proven to be effective in its intra-articular use, Platelet-rich plasma may help in the treatment of these patients.

Goal:

Primary objective: To compare effectiveness in improving pain and function and the medium-term tolerance (12 weeks) of intra-articular injection of Platelet-rich plasma versus intraarticular injection of triamcinolone hexacetonide in patients with symptomatic primary knee osteoarthritis.

Secondary objective: To compare the medium-term effectiveness of intra-articular injection of Platelet-rich plasma versus intra-articular injection of triamcinolone hexacetonide to improve synovial hypertrophy and quality of life in these patients.

Methods: A prospective randomized controlled double-blind study with three groups (each with n = 33) of patients with symptomatic osteoarthritis of knees who will receive intra-articular infiltration in a single moment. Patients will be allocated to one of three groups: 1) Platelet-rich plasma group: patients who will receive plasma; 2) triamcinolone hexacetonide Group: patients who will receive 40mg of triamcinolone hexacetonide; And 3) Isotonic saline solution group: patients who will receive isotonic saline solution. The patients will be evaluated by "blind" evaluators in 4 assessment times up to 12 weeks of follow-up through clinical assessment instruments (rest and movement pain, joint edema, goniometry, clinical improvement scale, quality of life questionnaire as the SF36), functional (Womac questionnaire, M. Lequesne Functional Knee Index, 6 min walk test, Time up and go test), and ultrasound test (quantitative and semiquantitative measurement of synovial hypertrophy and semiquantitative Power Doppler).

Statistics: The following statistical tests will be used according to the need: Student's t test, Mann-whitney, Pearson's chi-square test and ANOVA for repeated measures. A statistical significance of 5% will be considered.


Eligibility Criteria:
Inclusion Criteria:

* primary knee osteoarthritis
* degree II and II in Kellgren \& Lawrence classification
* pain duration: more than three months
* pain in the visual analogue scale between 4 and 8cm
* agree in participate and sign the consent form

Exclusion Criteria:

* secondary knee osteoarthritis
* skin lesion in knee
* intraarticular joint injection in the previous three months
* steroids use in the previous 30 days
* degree I or IV in Kellgren \& Lawrence classification
* inflammatory arthritis, gout and pseudo-gout
* cancer
* previous surgery in knee
* cardiovascular and respiratory disease that change functional status
* pregnancy and breastfeed
* coagulation disturb
* bacterial infection
* handicapped
* NSAIDs and Platelet anticoagulant in the previous month
Tumor Vaccines for Solid Tumors

Glioma is the most common primary malignant intracranial tumor, characterized by limited clinical treatment options and extremely poor prognosis. There is an urgent need for the development of new technologies and clinical practice. With the advancement of immunotherapy, tumor therapeutic vaccines have emerged as a hot topic in the field of solid tumor immunotherapy. Several clinical trials have confirmed that tumor vaccines can improve the prognosis of glioma patients. Vaccines are the first systemic treatment technology in nearly 30 years that can simultaneously extend the overall survival of patients with newly diagnosed glioblastoma and recurrent glioblastoma in Phase III clinical trials. This novel approach holds significant clinical value and brings hope to large number of patients. Our team has previously developed a dendritic cell (DC) vaccine for glioma, and the phase II clinical trial has demonstrated that it can extend the prognosis of glioma patients. However, several patients benefit less from vaccine therapy. Therefore, the identification of molecular mechanisms that render patients unresponsive to vaccine treatment is critical to improving vaccine efficacy. This project aims to collect various types of clinical samples from patients, including glioma patients receiving tumor vaccine treatment, glioma patients receiving conventional clinical treatment without tumor vaccine, and non-tumor patients (hemorrhagic stroke, ischemic stroke, and traumatic brain injury). High-throughput sequencing techniques will be used to establish an immune microenvironment database, followed by bioinformatics analysis and molecular biology experiments to uncover the molecular mechanisms influencing vaccine efficacy. Artificial intelligence and deep learning technologies will be employed to extract molecular mechanisms related information from radiology images and pathology images. Ultimately, the project seeks to establish an integrated diagnostic and treatment model that combines imaging, pathology, and omics data to advance the clinical application of vaccines.


Eligibility Criteria:
Inclusion Criteria:

The patients with glioma patients/non-tumor patients (hemorrhagic stroke, ischemic stroke, and traumatic brain injury) in the Department of Neurosurgery of Huashan Hospital Affiliated to Fudan University who meet the following three conditions can be enrolled:

1. They were no age limit, male and female;
2. The pathological results of frozen section during operation were gliomas or non-tumor;
3. Tissue (6 mm \* 6 mm) can be used for cell sorting on the basis of not affecting clinical routine diagnosis;
4. Sign informed consent.

Exclusion Criteria:

Patients who meet any of the following criteria will not be included in this study:

1. Participants in other clinical trials;
2. Pregnant women.