cyrilzakka/clinical-trials huggingface dataset:
Guided Application of Ventricular Catheters

Failure of ventricular catheters remains a significant problem in patients with hydrocephalus. The purpose of this study is to determine whether the use of a simple instrument assisted by a smart phone application software can achieve a more precise placement of ventricular catheters than the standard free-hand placement technique.

Free-hand placement of ventricular catheters (VC) is reported to be inaccurate in 10-40%. Furthermore, there is evidence that the quality of VC positioning is correlating with the risk for proximal shunt obstruction. Ultrasound or neuronavigation are used in order to improve to placement. However, they are associated with significant technical efforts and increased time.

In this study a simple instrument assisted by a smart phone application software is used in order to achieve precise placement of ventricular catheters. The results are compared with the standard free-hand procedure. Patients requiring a ventricular catheter are randomized to one of the two treatments. The primary outcome parameter is a qualitative and quantitative assessment of the position of the ventricular catheter on a post-operative image. The evaluation of the primary criteria is performed by a radiologist blinded to the randomization arm.

Eligibility Criteria:
Inclusion Criteria:

* Patients requiring a permanent ventricular catheter for the treatment of CSF (cerebrospinal fluid) - circulation disorder or another disease (ventricular shunt oder Ommaya/Rickham-Reservoir)
* Frontal occipital horn ratio (FOHR) \< 0.5
* Use of a new puncture channel
* Frontal access to the ventricles
* Patient´s informed consent

Exclusion Criteria:

* Known unevenness of the skull at the entry point
* Slit ventricles; Frontal and occipital horn width ratio (FOHWR) \< 0.05
* Participation in another clinical trial with interfering endpoints
Study to Examine Effect of Recombinant Luteinizing Hormone (r-Lh) and Recombinant Human Chorionic Gonadotropin (r-hCG) for Ovarian Stimulation in Assisted Reproduction Techniques (ART)

The study is a prospective, randomised, controlled, and non-blinded multi-center pilot study to evaluate endocrine efficacy of recombinant luteinizing hormone versus recombinant human chorionic gonadotropin administered during controlled ovarian stimulation for IVF/ICSI in normogonadotrophic women.


Eligibility Criteria:
Inclusion Criteria:

* Women who plan to undergo IVF or ICSI treatment
* Woman's age \> 18 years but ≤ 35 years
* Regular menstrual cycle (25-34 days)
* BMI 18 to 30 inclusive
* Signed patient information and informed consent forms

Exclusion Criteria:

* PCOS
* More than 2 prior IVF/ICSI attempts
* Diabetes mellitus, epilepsy, lever-, kidney-, heart- and metabolism disorders, according to the Investigator's assessment.
Study Evaluating Cemiplimab Alone and Combined With RP1 in Treating Advanced Squamous Skin Cancer

To estimate the clinical benefit of cemiplimab monotherapy versus cemiplimab in combination with RP1 for patients with locally advanced or metastatic CSCC, as assessed by overall response rate (ORR) and complete response rate (CRR) according to blinded independent review.

RP1 is a selectively replication competent herpes simplex virus type 1(HSV-1). This is a Phase 1/2, open-label, multicenter repeat-dosing study of RP1 alone and in combination with nivolumab in patients with advanced malignancies, and contains both single agent dose escalation, dose expansion to include nivolumab, and the combination in multiple Phase 2 cohorts in individual tumor types.

Eligibility Criteria:
Key Inclusion Criteria:

* Histologically confirmed locally advanced or metastatic cutaneous squamous cell carcinoma
* Patients with locally advanced disease who are not suitable candidates for surgical or radiological treatment of lesions or have refused those treatments
* At least 1 lesion that is measurable and injectable by study criteria
* Eastern Cooperative Oncology Group (ECOG) performance status ≤1. Patients with ECOG PS 2 at baseline may be allowed to enroll if PS 2 status is only related to the CSCC disease under study
* Anticipated life expectancy \>12 weeks
* All patients must consent to provide archived or newly obtained tumor material for central pathology review for confirmation of diagnosis of CSCC.

Key Exclusion Criteria:

* Prior treatment with an oncolytic therapy
* Patients with active significant herpetic infections or prior complications of HSV-1 infection (e.g. herpetic keratitis or encephalitis)
* Patients who require intermittent or chronic use of systemic (oral or intravenous) anti-virals with known anti-herpetic activity (e.g. acyclovir)
* Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments
* Prior treatment with an agent that blocks the PD-1/PD-L1 pathway.
* Prior treatment with other immune modulating agents other than as adjuvant or neoadjuvant therapy within 3 years.
* Untreated brain metastasis(es) that may be considered active.
* Acute or chronic active hepatitis B or known history of hepatitis B or hepatitis C or human immunodeficiency virus (HIV) infection
* History of ILD/pneumonitis within the last 5 years or a history of ILD/pneumonitis requiring treatment with systemic steroids.
* Any major or surgical procedure ≤ 28 days before randomization
* Administration of live vaccines ≤ 28 days before randomization

Note: Other protocol defined Inclusion/Exclusion criteria apply.
A Study of Diagnosis and Treatment of Depression Based on Biological Evidence of Dopamine Reward Pathway

This study will recruit depressed patients unresponsive to selective serotonin reuptake inhibitor antidepressant treatment, first-degree relatives (parents or siblings) of depressed patients, schizophrenia, Parkinson's disease with and without depression, and healthy controls. The subjects need to complete the brain positron emission tomography/magnetic resonance examination, stress assessment, genetic testing, clinical evaluation and neuropsychological tests. Using the data, this study aimed to identify the abnormalities of reward circuit of depression and its differences with other diseases, and its abnormalities in first-degree relatives of depression. The depressed patients who were ineffective in treatment with selective serotonin reuptake inhibitor antidepressants were then given combined medication with dopamine receptor-mediated drugs, including dopamine transporter inhibitor - bupropion, D2 receptor antagonist - risperidone, or D2 receptor partial agonist - aripiprazole, to examine the regulation of dopamine pathway and its relationship with the therapeutic effect. Through the above work, we will provide new evidence for integrating the biological evidence of dopamine reward pathway into the clinical practice of depression.


Eligibility Criteria:
Inclusion Criteria:

* patients unresponsive to SSRI antidepressant treatment, first-degree relatives (parents or siblings) of depressed patients, schizophrenia, Parkinson's disease with and without depression, and healthy controls

Exclusion Criteria:

* Major physical illness; other DSM-IV axis I mental illness; personality disorder, mental retardation; drug and/or alcohol dependence; pregnant or lactating women; MRI examination contraindications.
Tertiary Lymphoid Structures Related Genes Predicting Prognosis in Clear Cell Renal Cell Carcinoma: a Retrospective Cohort Study

The purpose of this research was to uncover the prognostic significance of tertiary lymphoid structures related genes from ccRCC patients with respect to clinical characteristics and outcomes. This offers a novel perspective on selecting populations for prostate cancer immunotherapy in future scenarios.


Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with renal cell carcinoma

Exclusion Criteria:

* incomplete medical records, inadequate follow-up information, and confirmed non-prostatic acinar adenocarcinoma
TETRAGRIP II - Usability Trial of an FES Orthosis for People With Tetraplegia.

Functional Electrical Stimulation is an established technique in which small electrical impulses are used to cause a contraction in muscles and thereby enable movement, in people with neurological or musculoskeletal problems who are unable to undertake those movements themselves. People with spinal cord injuries of the neck at C5, C6 and C7 account for 35% of all spinal cord injuries. Despite this, there is only one commercial FES (Functional Electrical Stimulation) based orthosis currently available. Even that has limitations in that it as it has a single size rigid exoskeleton it does not fit all people who could benefit and also due to its rigidity it does not allow people with lower injuries to utilise any remaining tenodesis grip. As a result, it is not widely used within the spinal injured communities. Therefore what is required is a more flexible system that can benefit a larger number of people whilst still being affordable within the constraints of the NHS. A previous INSPIRE funded project, TETRAGRIP I demonstrated that a surface FES system controlled by an inertial sensor, measuring movement of the opposite shoulder, could meet this specification and was successfully tried on two people with tetraplegia. What is now required is a more detailed study in which the principle components of that system are incorporated into a practical device suitable for use at home without clinical supervision. It is therefore proposed to develop and build such a system and to conduct extended home based trials in three people with tetraplegia.


Eligibility Criteria:
Inclusion Criteria:

* Have a spinal cord injury that has resulted in tetraplegia affecting hand function.
* Minimal spasticity of wrist muscle.
* Able to do shoulder elevation.
* Upper limb passive range of motion should be within normal limit.
* Age group: 18 years and above.
* Able to understand and comply with assessment procedures.
* Able to give informed consent.
* Able to produce a muscle contraction using electrical stimulation in sufficient muscles produce a functional grip.

Exclusion Criteria:

* Using a cardiac pacemaker, defibrillator or other sensitive implanted device.
* Pregnant or planning to become pregnant over the course of the study.
* A history of poorly controlled epilepsy.
* If there is malignancy on the hand or arm.
* If younger than 18
* Severe contracture of wrist and finger joints.
* Painful shoulder.
* Suffering from significant autonomic dysreflexia in response to FES.
Predictors for Postoperative Delirium After Cardiac Surgery in Adults: a One-year, Single Center, Observational Cohort Study

The Diagnostic and Statistical Manual of Mental Disorders, 5th ed. (DSM-5) describes delirium as a "disturbance in attention (i.e., reduced ability to direct, focus, sustain, and shift attention) and awareness (reduced orientation to the environment)". In addition, a "disturbance in cognition (e.g., memory deficit, disorientation, language, visuospatial ability, or perception)" occurs.

Postoperative delirium (POD) usually develops in connection with a surgical procedure within the first five days after an intervention. Roughly 10-70% of all surgical patients above the age of 65 years are affected.

POD places not only a burden to the patient and their families by increasing functional and cognitive damages, and increasing mortality, it also has a high impact on the health care resource utilization. A patient with POD often requires more intensive care, has a longer length of hospital stay, more complications, and often requires long-term care after being discharged from the hospital. All these aspects show the need for prevention of POD.

There are various preoperative risk factors that influence the development of POD. Broad research has been done on this topic and shown that advanced age, cognitive impairment, depression and other psychopathologic symptoms, intake of psychotropic substances, sensory impairment like decrease in visual or auditory perception, impairment in daily life activities, dehydration, malnutrition, metabolic dysfunctions, urinary catheters, severity of disease and different comorbidities, such as chronic cardiac insufficiency, atrial fibrillation, or previous history of stroke or infections may favor the occurrence of POD.

The incidence of POD is among the highest in cardiac surgery. The study was designed to assess predictors for POD after cardiac surgery. Study hypothesis is that some patient variables, scores and biomarkers are not only predictive of the incidence of POD but also of the severity of delirium-associated symptoms and duration of POD after cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

All patients who underwent cardiac surgery with cardiopulmonary bypass at University Hospital Basel in 2013 were included.

Exclusion Criteria:

* Patients who died during the operation.
* Patients who lack the primary outcome measure.
Conventional Versus Left Bundle Branch Pacing in TAVI

This randomized study compares the effects of conventional (right ventricular pacing in patients with LVEF ≥ 40% and cardiac resynchronization therapy in patients with LVEF \< 40 %) versus left bundle branch pacing on left ventricular remodelling in patients with reduced left ventricular ejection fraction (\< 50 %) that need permanent pacemaker implantation after transcatheter aortic valve implantation (TAVI).

Bradycardic heart rhythm disturbances are a common complication of TAVI. Patients who will develop the indication for permanent pacemaker implantation after TAVI will be randomly assigned to either the experimental (left bundle branch pacing) or conventional (right ventricular pacing in patients with LVEF ≥ 40% and cardiac resynchronization therapy in patients with LVEF \< 40 %) group. The investigators will compare the left ventricular ejection fraction (primary outcome) 12 months after randomization. The investigators will also compare electrocardiographic (QRS duration), clinical (NYHA status, 6-minute walking test, handgrip test, Kansas City Cardiomyopathy Questionnaire) and laboratory (proBNP) parameters 6 and 12 months, and other echocardiographic (left ventricular systolic and diastolic diameter, signs of dyssynchrony, myocardial work) parameters 12 months after pacemaker implantation in both groups.

Eligibility Criteria:
Inclusion Criteria:

* Indication for permanent pacemaker implantation after transcatheter aortic valve implantation (during the same hospitalization)
* Left ventricular ejection fraction \< 50 %.

Exclusion Criteria:

* Unsuccessful TAVI procedure with life expectancy \< 1 year
* Ischemic cardiomyopathy with interventricular septal fibrosis (at least echocardiographic signs of fibrosis)
* Severe kidney failure (glomerular filtration rate \< 30 ml/min)
* Previous permanent pacemaker
Effectiveness of a Jaw Exercise Program in Temporomandibular Disorders Patients

This study evaluates the effect of jaw exercise therapy in the treatment of temporomandibular disorder patients (TMD). An eligible group of patients will be treated with that therapy (experimental group) and another group will be treated with counseling and occlusal splint (control group), considered the standard therapy for TMD.

Mandibular exercises may have behavioral and cognitive action, educating the patient and serving as an instrument of control of parafunctional activity. It is a simple, easy, which seeks adherence to treatment and has negligible cost. A disadvantage is the need of motivation and discipline of the patient in carrying out the therapy daily. The occlusal splints, associated with educational guidance and counseling have world indication the possibility of promoting teeth protection, joint decompression, equalization of electromyographic activity, conscious control of parafunctional activity and strong placebo effect.

Eligibility Criteria:
Inclusion Criteria:

* Females, aged 20-45 years, clinical diagnosis of muscular TMD form mild to moderate according to the Criteria of the Diagnostic and Research of TMD (RDC / TMD), good reception and understanding of spoken Portuguese, able to provide a informed consent, and be available to attend the evaluation returns.

Exclusion Criteria:

* Rheumatic, vascular, neurological, infectious or neoplastic disease, cognitive or motor problems, pregnancy status or use of abusive drugs, chronic facial pain history (2 years or more), refuses to participate in the study.
The Prospecive OBSERVational Munich Interventional MITRAl-Valve Registry

Prospective, single-center observational registry including all consecutive patients treated with transcatheter mitral or tricuspid valve therapy at the Deutsches Herzzentrum München, Germany.

Long-term mortality after transcatheter mitral or tricuspid valve therapy

Eligibility Criteria:
Inclusion Criteria:

* Age above 18 years and consentable
* Mitral Valve Regurgitation, Mitral Valve Stenosis, Tricuspid Valve Regurgitation, Tricuspid Stenosis
* Transcatheter mitral or tricuspid valve therapy considered best option by heart-team decision
* Written informed consent

Exclusion Criteria:

* Patient's inability to fully cooperate with the protocol
Post-exercise Hypotension After a Power Training Session in Older Adults With Hypertension

The main purpose of the present study was to evaluate the effect of a power training session on office and 24h ambulatory blood pressure in older adults with hypertension. As secondary outcomes, the investigators compared post-exercise hypotension, BP variability, and endothelial function between older men and women with hypertension.

The working hypothesis was that a single bout of power exercise would decrease both office and 24 h BP in comparison to a non-exercising control session and men and women would respond differently after a power training session.

Participants randomly performed two experimental sessions: power exercise training (PT) and non-exercising control at seated rest (Con). They maintained their current antihypertensive medications throughout the trial. Each session was composed of 20 min of rest in the supine position, 40 min of PT or Con protocols, and 60 min of rest in supine position after protocols. The PT was composed of 3 sets of 8-10 repetitions of 5 exercises performed in the following order: leg press, bench press, knee extension, upright row, and knee flexion, using an intensity corresponding to 50 % of 1-RM and two-minute intervals between sets and exercises. The concentric phase of exercises during each repetition was performed "as fast as possible" while the eccentric phase lasted 1-2 seconds. During the Con, the participants remained seated rest on the same exercise machines, but without any exercise. Standardized office BP was performed before and during the first hour (in intervals of 15 min) after exercise and control sessions. Together with the office BP evaluation in the pre and post sessions, the endothelium-dependent brachial vascular function was evaluated using Flow-mediated dilation. Afterwards, participants underwent 24h ambulatory BP monitoring..

Eligibility Criteria:
Inclusion Criteria:

* Office blood pressure between 130-179 and 80-110 mmHg for systolic and diastolic blood pressure, respectively;
* Non-engaged in structured programs of exercise for the last 3 months since the beginning of this study;
* Able to perform the proposed exercises.

Exclusion Criteria:

* Underlying cardiovascular disease previously diagnosticated by a doctor, occurred in the last 24 months, such as: acute myocardial infarction, angina, stroke or heart failure;
* Diseases that reduce life expectancy;
* Smokers and ex-smokers for less than six months;
* BMI \> 39.9 kg/m²
* diabetic proliferative retinopathy.
Ultrasound Utility in Routine Clinical Practise

The aim of this research study is to describe the impact of rheumatologist performed ultrasound on the diagnosis and management pathways of patients with rheumatoid arthritis. Primarily, to compare the time from first visit to treatment initiation between patients with and without rheumatologist-performed ultrasound assessment.

There are currently no guidelines for best practice in the use of ultrasound in RA and interim results from a survey by the British Society of Rheumatology (BSR) in this area have suggested that practice is variable across the UK. NICE recognize that the earlier persistent synovitis is identified and treated with disease modifying anti-rheumatic drugs DMARDs, the better the long term outcome and have welcomed the need to determine the role of imaging in assisting with this early diagnosis, and whether the added cost is justified by better disease outcomes.

This is a multi-site prospective observational study which investigates the use of ultrasound imaging in the context of patients with early arthritis presenting to secondary care. The time to commencement of DMARD therapy and diagnosis of Rheumatoid arthritis are therein outcome measures. Patients are followed up for 12 months after their first presentation and time to diagnosis or DMARD commencement recorded.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥18 years at the time of presentation to the clinic Patients newly presenting to the rheumatology clinic with suspected inflammatory arthritis

Exclusion Criteria:

* For the non-ultrasound arm; patients who have been referred to another rheumatologist or radiologist for ultrasound Patients who decline or who are unable to consent to the use of their medical records for research
Evaluation of a Model for the Early Diagnosis of Colorectal Cancer by the Detection of 5-hydroxymethylcytosine (5-hmC) in Plasma Cell-free DNA to the Community Colorectal Cancer Screening Program

The incidence rate and mortality of colorectal cancer are increasing year by year. Most colorectal cancer develops from colorectal adenoma and is a disease that can be prevented and controlled. Thanks to early screening, the incidence rate and mortality of colorectal cancer have declined year by year. However, due to poor compliance with colonoscopy and the lack of efficient and convenient early screening methods, it is difficult to screen for colorectal cancer in China. According to the data from Shanghai Xuhui District Center for Disease Control and Prevention, the proportion of colonoscopies in high-risk groups for colorectal cancer is less than 18%.

This project plans to use the latest colorectal cancer screening technology, namely, 5hmC detection in peripheral blood and DNA methylation detection in feces, for those who are positive in the colorectal cancer incidence risk questionnaire or fecal occult blood in Xuhui District, Shanghai. It is strongly recommended that subjects with positive screening should undergo colonoscopy, to effectively improve the rate of colonoscopy and the early diagnosis rate of colorectal cancer. At the same time, to explore the screening efficiency of the early diagnosis model of 5hmC cancer.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 50 years old and\<75 years old;

  * The initial screening was positive (fecal occult blood or colorectal cancer risk questionnaire was positive)； ③ Receive sample collection; ④ Sign the informed consent form.

Exclusion Criteria:

① History of colorectal cancer, colorectal adenoma, and treatment;

* Enteroscopy was performed after the initial screening was positive; ③ The subject or family members could not understand the conditions and objectives of the study or refused to participate in the study.