cyrilzakka/clinical-trials huggingface dataset:
Visual Feedback With Optical Sensing - A Feasibility Study

Lung cancer is the second most common cancer in the United Kingdom with around 40,000 new cases diagnosed every year. Lung cancer is associated with a very poor prognosis (\<10% patient survival at 5 years). New strategies are urgently needed to improve survival in this group of patients.

The most effective and common treatment for lung cancer is radiotherapy (either alone or combined with chemotherapy and/or surgery) and generally high doses of radiotherapy are given to the tumour. However, increasing the radiotherapy dose carries an increased risk of damage to the surrounding healthy tissue. Damage can be minimised by reducing movement within the lung, caused by factors such as breathing and patient motion, during treatment.

This study tests a new medical device that has been developed to monitor and help patients control their breathing and movement during treatment. Optical sensors will detect any motion of the patient's torso and this will be fed back to the patient in the form of a visual aid allowing them to regulate their breathing and maintain their ideal treatment position.

The device has already been shown to reduce motion in healthy volunteers. In this study the investigators hope to demonstrate that the visual aids are tolerable in lung cancer patients. The investigators additionally aim to show the device will help reduce movements of the chest and also the lung tumour, leading to improvements in treatment results.

In this study each participant will undergo 4 imaging sessions (one training session and 3 study sessions) where participants will be asked to use the optical feedback display to regulate breathing patterns.

The training session and each study session will proceed as follows:

* The patient receives standard treatment including any pre-treatment Cone Beam CT (CBCT) imaging.
* The patient is allowed to get up off the treatment couch and relax whilst the sensor device is turned on.
* The patient is set-up again.
* The patient is asked to free-breathe (i.e. breathe normally) and the surface motion is recorded using the optical sensor. The first 30 seconds are used to generate the reference surface used throughout the rest of the process. A 4D CBCT scan is acquired during free-breathing to assess tumour motion.
* The patient is then asked to control their breathing using the feedback displays and data is recorded for \~1:30 minutes in each case.
* A 4D CBCT scan will be acquired during controlled breathing with the traffic light feedback visualization scheme to assess tumour motion.

Eligibility Criteria:
Inclusion Criteria:

* Stage 1-3 lung cancer (Non Small Cell Lung Cancer and Small Cell Lung Cancer; histological diagnosis not mandatory) including at least 5 patients with lower lobe tumours
* Suitable for radical radiotherapy
* Tumour judged inoperable by a thoracic surgeon
* At least 18 years old

Exclusion Criteria:

* Stage 4 Non Small Cell Lung Cancer
* Unable to give informed consent
* Epilepsy or migraine
Acute Cardioversion Versus Wait And See-approach for Symptomatic Atrial Fibrillation in the Emergency Department

A symptomatic episode of the heart rhythm disorder 'atrial fibrillation' (AF) is a frequent reason for visits to the emergency department. Currently, in the majority of cases, immediate (electrical or pharmacological) cardioversion is chosen, while atrial fibrillation terminates spontaneously in 70% of the cases within 24 hours. A wait-and-see approach with rate-control medication only, and when needed cardioversion within 48 hours of onset of symptoms, could be effective, safe and more cost-effective than current standard of care and could lead to a higher quality of life.


Eligibility Criteria:
Inclusion Criteria:

* ECG with atrial fibrillation at the emergency department
* Heart rate \> 70bpm
* Symptoms most probable due to atrial fibrillation
* Duration of symptoms \< 36 hours
* \> 18 years of age
* Able and willing to sign informed consent
* Able and willing to use MyDiagnostick

Exclusion Criteria:

* Signs of myocardial infarction on ECG
* Hemodynamic instability (systolic blood pressure \< 100mm Hg, heart rate \> 170 bpm)
* Presence of pre-excitation syndrome
* History of Sick Sinus Syndrome
* History of unexplained syncope
* History of persistent AF (episode of AF lasting more than 48 hours)
* Acute heart failure
* Currently enrolled in another clinical trial
* Deemed unsuitable for participation by attending physician
Microbial Restoration in Inflammatory Bowel Diseases

This is a prospective, two-centre, double-blind, parallel-arm, randomised, placebo-controlled trial evaluating the impact of FMT on patients with active Crohn's disease.

The study will be conducted in two parts. The first part will involve all patients undergoing an optimisation phase, followed by randomisation into either intervention or placebo arms of the induction phase of the study. For patients achieving a pre-determined clinical response threshold at week 8 they will be re-randomised into the maintenance phase of the trial for a further 44 weeks.

FMT will be anaerobically prepared, freeze-thawed for administration.

Eligibility Criteria:
Inclusion Criteria:

Active Crohn's disease

* Confirmed endoscopic active inflammation (unless isolated small bowel disease that is inaccessible by endoscopy in which case sonographic inflammation is sufficient) within 6 months of study entry AND
* CDAI score of 220-450 AND
* One of the following:

  * CRP ≥5mg/L
  * faecal calprotectin ≥100μg/g
  * inflammation on imaging (either intestinal ultrasound or magnetic resonance imaging)
* Willing and able to attend the study sites for regular endoscopic procedures.

Exclusion Criteria:

Active perianal or fistulising disease; Pregnant or intending to become pregnant within 12 months; Enteropathy or colitis other than Crohn's disease; Symptomatic intestinal stricture likely to require surgical treatment; Presence of a stoma; Presence of an ileoanal pouch; Total white cell count less than 3.0 x 109/L; Albumin less than 20g/L; Immunodeficiency (beyond that caused by immune suppressants used for the treatment of IBD) e.g. HIV or Common variable immune deficiency; Anaphylaxis/severe allergy to food; Thiopurine, methotrexate, biologic agent or small molecule inhibitors or aminosalicylates whose dose has been modified within the past two months, 1 month and two weeks of study entry, respectively; Prebiotic, probiotic or antibiotic therapy, or over-the-counter supplements therapy in the two weeks prior to study entry; Rectal topical Crohn's disease therapy in the 2 weeks prior to study entry; Prednisolone dose \>20mg or budesonide dose \>6mg; Unwilling or unable to taper corticosteroids to zero within 8 weeks of initial FMT; Active gastrointestinal infection; Alcohol consumption of a dependent nature; Primary sclerosing cholangitis; Any condition that the treating gastroenterologist deems to pose a theoretical risk to the patient undertaking FMT; Any patient that the treating clinicians feel is incapable of participating in the safe use of FMT.
Novel MRI Sequence MR Fingerprinting in Breast MRI Feasibility Study

The purpose of this study is to evaluate potential clinical efficacy of a novel magnetic resonance imaging (MRI) approach, MR fingerprinting, capable of providing quantitative measures of important tissue properties, which could provide important insights into normal breast tissue. This new MRI sequence will be added to the screening breast Dynamic Contrast Enhanced (DCE) MRI for high risk normal patients.

This is a feasibility study of the use of the additional MR fingerprinting (MRF) scanning sequence with a total of 12 minutes scanning time to our clinical screening breast DCE MRI examination before contrast medium injection and at the end of scan. This additional scanning sequence may provide faster and better quantitative tissue characterization comparing to conventional MR sequences. There is no investigational contrast agent in this study. We propose that the additional MRF sequence may provide faster and more accurate tissue characteristics imaging for clinical evaluation of breast tissue. Patients will be enrolled in with scheduled high risk screening DCE MRI (n=30). The MR imaging will be performed in the clinical 1.5T MR scanners in UNC as normally done for the patients MRI schedule. We only add an additional MRF sequence within the MRI exam just prior to the contrast enhancement scan.

Quantitative measurement of the breast tissue will be performed after the MR exam. The region-of-interest (ROI) of normal breast parenchyma was recorded. The ROI will be saved and encoded to the T1 map, T2 map in MRF, T1 weighted imaging, T2 weighted imaging. A large variety of imaging ROI-based quantitative measures will be calculated among normal glands in bilateral breasts to evaluate different ROI characteristics among different patients and between bilateral breasts in each patient.

Eligibility Criteria:
Inclusion Criteria:

* English-speaking patients
* Ages 18 to 99 years old
* Scheduled to undergo a screening breast MRI study
* Capable and willing to provide signed informed consent

Exclusion Criteria:

* Claustrophobia
* Presence of pacemaker, intracranial aneurysm clip, bladder stimulator, cochlear implant or metal near eyes or near pelvis that would create excessive imaging artifact
* Known hypersensitivity to contrast agent or to any component of contrast agent refractory to standard medications (antihistamines, steroids)
* Impaired kidney function (serum creatinine level \> 1.8 mg/dl or a glomerular filtration rate \< 60 as approximated using serum creatinine levels) unless anuric and on dialysis.
* Inability to tolerate MRI (e.g., inability to lie flat for \>1 hour)
* Pregnancy or lactating female
* Previous history of mastectomy or lumpectomy
* Breast enhancements (i.e. implants)
Assessing the Colgate Assist Handle Toothbrush in Individuals With Impairment of Hand Movement.

User experiences of Colgate Assist Handle toothbrush as indicated by questionnaire and interview

Video recording of tooth brushing technique Picture of toothbrush bristles after study period

Eligibility Criteria:
Inclusion Criteria:

* Individuals with specific movement disorders and physical impairments, such as, but not limited to, Parkinson disease, Huntington disease, multiple sclerosis, arthritis, cerebral palsy, stroke, and/or tremors that affect their ability to perform daily tasks, such as brushing their teeth.

Exclusion Criteria:

* Individuals with severe oral health issues such as oral cancer, ulcers, or severe periodontal disease.
* Individuals who are unable to open their mouth enough that it would prevent using a brushing device.
Omnifit Hydroxylapatite (HA) Hip Outcomes Study

The purpose of this study was to obtain up to 25 year post-operative data on the Omnifit Hydroxylapatite (HA) Hip System in support of the hypothesis that it is a satisfactory system for reducing implant loosening, permitting tissue bonding onto the hydroxylapatite surfaces of the implant and providing a safe, efficient, and well-functioning hip in a wide spectrum of clinical circumstances.


Eligibility Criteria:
Inclusion Criteria:

For use as a universal hip replacement:

* Acute femoral neck fracture.
* Non-union of femoral head and neck fractures.
* Aseptic necrosis of the femoral head.
* Osteoarthritis, rheumatoid arthritis, or post-traumatic arthritis of the hip with minimal acetabular involvement or distortion.
* Salvage of failed total hip arthroplasty.

For use as a total hip replacement:

* Severely disabled joints resulting from painful osteoarthritis, rheumatoid arthritis, or post-traumatic arthritis.
* Revision of previous unsuccessful femoral head replacement, cup arthroplasty, or other procedure.

Exclusion Criteria:

* Active infection in or near the hip joint.
* Pathological bone conditions which would significantly compromise the ability to carry physiologic stress levels and for which bone grafting would be inappropriate (i.e. severe osteoporosis, Paget's Disease, renal osteodystrophy, etc.).
* Neuro-muscular disorders in which the potentially adverse effects on prosthesis function are not outweighed by the benefits to be gained by the patient from usage of the implant.
* Mental disorders which would compromise essential patient post-operative care.
* Skeletal immaturity.
* Extreme obesity.
* Significant probability that patient could not return for required follow-up evaluations.
Effects of Recreational Soccer Training on Physical Fitness and Gross Motor Coordination in Prepubertal Boys and Girls

Physical activity is essential for the healthy development of children, contributing significantly to their physical fitness and motor skills. Prepubertal children experience changes in physical growth. During the prepubertal phase, engaging in regular physical activity can lead to substantial improvements in cardiovascular health, muscular strength, agility, and coordination. Physical fitness has been recognized as a key determinant in healthy lifestyles based increasingly on criteria referenced to general health. However, many children and adolescents are only exposed to vigorous physical activity during school based physical education classes. That way, schools seem to provide an excellent setting to enhance physical activity and physical fitness levels. Soccer, a widely popular sport, offers an engaging and enjoyable way for children to improve their physical fitness and gross motor coordination.

This study aims to investigate the effects of recreational soccer training on physical fitness and gross motor coordination in prepubertal boys and girls and to compare the effects of recreational soccer training between boys and girls. This current study will be a clinical trial; data will be calculated from Dar-e-Arqam School, upper mall Lahore. A total of 70 prepubertal children (35 boys and 35 girls) will be recruited for this study. Inclusion criteria for the study will be 7 to 9 years old boys and girls. participants should be in good general health, without any medical condition that could affect their ability to participate in physical activities. Individuals with physical disabilities or impairments that prevent them from engaging in soccer activities will be excluded. Participants will be divided into two experimental groups: Group A (boys) and Group B (girls). Both groups will undergo the same soccer training program. The soccer training program will consist of sessions held thrice a week for 8 weeks, each lasting 60 minutes.Outcomes to be analyzed will be Physical fitness and Gross motor coordination. Data collection will be done before and after the intervention. Tools used for data collection will be Physical fitness test battery for children to assess physical fitness and rohrer's index will be used to assess somatotype. Gross motor coordination will be evaluated using the Körperkoordinations test für Kinder (KTK) test battery. Data will be analyzed through SPSS version 26.00.


Eligibility Criteria:
Inclusion Criteria:

* Children between age 7 to9
* Flamingo balance test between 11-14
* Both genders

Exclusion Criteria:

* Presence of any chronic medical condition
* Children who areinvolved inother training program
* Having any physical disability or impairment
Heated Glass Ionomer Cement in Primary Molars

Objective: The aim of this study was to assess the influence of heated in the clinical success of proximal high viscosity glass ionomer cement (GIC) restorations in primary molars.

Material \& Method: This randomized, split mouth, multicenter study was performed in four different centers including 88 patients aged between 5-7 years old. Selection criteria included clinically and/or radiographically detected proximal caries extending into the dentin tissue. A total of 250 primary molars were restored with a bulk fill GIC (Equia Forte, GC, Europe) and randomly allocated to one of the following groups: 1) non-heated (n = 125) and 2) heated (n = 125). LED light (GC- D-Light DUO, Tokyo Japan) was used at standard mode 1200 mW/cm2, at 50-60 ºC, for 60 sec for heat application. All restorations were clinically evaluated using modified USPHS criteria at the baseline, 6 months and 12 months. Chi-square test, Fisher's Exact Chi-square test, Continuity (Yates) correction, Fisher Freeman Halton test and Mc Nemar test were used to compare qualitative data with descriptive statistical methods (frequency). Kaplan Meier and Life Tables were used for survival analysis. P value \< 0.05 was considered statistically significant.


Eligibility Criteria:
Inclusion Criteria:

* Subject is mentally and systemically healthy
* Subject has at least two approximal carious lesions at both sides of jaws
* Subject has a normal occlusal relationship with natural dentition
* Subject has at least one adjacent tooth contact

Exclusion Criteria:

* Subject has history of bruxism,
* Subject has allergies to ingredients of glass ionomer based restorative materials.
* Cavity/Caries has highly mineralized pigmented lesions, hypoplasia, fracture or cracks,
* Subject has abrasion, erosion, abfraction,
* Subject has fistula, abscess or pathological mobility,
* Subject has pain, pulp exposure
Clinical Evaluation of a Dental Glass Ceramic

A clinical trial with an experimental glass ceramic (shades A1, A2 and A3) to ensure the safety and efficacy of the product. It is a study with single-arm in which inlays and onlays for molars and premolars are adhesively luted.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18-65 years
* Indication for indirect restorations (inlay, onlay) in molar or premolar - replacement of insufficient fillings (e.g. due to caries at margins, filling fracture, fracture of the tooth, poor quality of the surface, leaking margin, etc.) or extensive primary caries
* The occlusal area of the restoration must cover at least 1/3 of the occlusal area of the tooth.
* Participant wishes a restoration within the scope of the study (signed informed consent after detailed explanation and study of the patient information)
* Pre-operative discomfort of the tooth to be restored should not exceed 3 on the visual analogue scale (VAS) (0=no pain, 10=maximum conceivable pain) due to temperature stimulus or bite sensitivity
* Max. 2 restorations per participant in different quadrants.
* Healthy periodontium, no active periodontitis
* Contact with adjacent teeth (at least at one side) and opposing teeth present with at least one contact point.
* Sufficient language skills

Exclusion Criteria:

* Sufficient isolation not possible, dry working field cannot be guaranteed
* Participants with a proven allergy to one of the ingredients of the materials used
* Participants with proven allergy to local anaesthetics
* High caries activity/ poor oral hygiene
* Participants with severe systemic diseases
* Pregnancy
* Symptoms of SARS (severe acute respiratory syndrome)-CoV2 (Corona Virus 2) infection
Factor Xa Inhibitor YM150 for the Prevention of Blood Clot Formation in Veins After Scheduled Hip Replacement (ONYX-2)

The purpose of this study is to find the best possible (optimal) dose (effect versus adverse events) of YM150 to prevent the risk of blood clot formation after scheduled hip replacement surgery.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for elective primary hip replacement
* Age 18 years or over
* Written informed consent obtained

Exclusion Criteria:

* Documented history or considered at increased risk of venous thromboembolism
* Subjects considered at increased risk of bleeding
* Surgery planned for contralateral hip at the same time or within 10 weeks after enrolment
* Concomitant use of anticoagulants/ antiplatelet agents
Erector Spinae Plane Block Versus Quadratus Lumborum Block for Postoperative Analgesia in Children

Postoperative pain management in children is still standing as a problem to solve. Effect of quadratus lumborum block has been shown to be a promising technique to overcome postoperative pain in children undergoing low abdominal surgeries. Erector spinae plane block is a new defined relatively safer and easier regional anesthesia technique which could be used for this purpose. Primary aim of this double blinded randomized controlled trial is to compare the analgesic efficacy of this two block techniques in this group of pediatric patients.


Eligibility Criteria:
Inclusion Criteria:

* 1-7 years of age
* ASA I-II
* Undergoing elective low abdominal surgery

Exclusion Criteria:

* infection of the skin at the site of needle puncture area
* patients with known allergies to any of the study drugs
* coagulopathy
* ASA III-IV
* Patients with neurological disorders
Dynamic Difficulty Adjustment in a P300 Speller Task for Attention Training

This study compares different adaptation approaches in a P300-based BCI neurofeedback training to improve short-term attention. Participants will spell several words on a computer by focusing on a letter on the screen while their brain activity is recorded (P300 speller). The difficulty of this task will be adapted to train their attention. Their cognitive abilities will be evaluated using a random dot kinematogram, where they are asked to indicate the direction a fraction of moving dots on the computer screen is going in, before and after the training to analyse any improvements. Questionnaires will be used to compare the perceived task load of the different adaptation approaches.

Healthy participants will complete several runs in a P300-speller task, where the number of flashes per row and column is progressively adapted to their performance (in control group 1 and experimental group) or chosen randomly (in control group 2). Decreasing the number of flashes per row and column makes it harder for the computer to identify the letter the participant is focusing on, which encourages them to improve their focus to maintain their performance. The number of flashes can therefore be interpreted as the task difficulty of the P300 speller task.

The participants will complete a continuous version of the random dot kinematogram, where a fraction of incoherently moving dots will start moving coherently. The participants are asked to indicate which direction these dots are moving in. This task is completed before and after the P300 speller training, so that response times in the task can be compared.

To evaluate the perceived task load of the different adaptation approaches, the participants will complete a questionnaire about fatigue and boredom before and after the training session, as well as the NASA Task Load Index at the end of the experiment.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* able to consent
* normal or corrected-to-normal vision

Exclusion Criteria:

* history of neurological or cognitive illnesses
* negative reaction to electroconductive gel used in the study (an allergy patch test will be carried out before the experiment starts)
* illiteracy