cyrilzakka/clinical-trials huggingface dataset:
Clinical Validation of Multimodal Digestive Endoscopy

According to the latest global cancer epidemiological data published by the International Agency for Research on Cancer, colorectal cancer (CRC) ranks 3rd in total incidence and 2nd in total mortality among all malignancies worldwide. The prognosis of CRC is directly related to tumor stage. The 5-year survival rate for early CRC can reach 90%, while less than 14% for advanced CRC. Therefore, early diagnosis of CRC is particularly important. Gastrointestinal (GI) endoscopy is an important method in the diagnosis of CRC. Currently, diagnosis of GI endoscopy is mainly based on morphological changes of tumors, while early-stage tumors are difficult to be detected because of the indistinguishable morphology. Studies have shown that the molecular function of cancer cells can be altered in early-stage tumors. The development of a new endoscopic system that can identify early tumor molecular function changes and improve the accuracy of morphological diagnosis will greatly improve the early diagnosis rate of CRC, which is the future direction of GI endoscopic system design and development.

The combination of high-definition white light endoscopy, endoscopic cerenkov luminescence imaging (ECLI) and probe-based confocal laser endomicroscopy (pCLE) is ideal for future new GI endoscopy. High-definition white light endoscopy is helpful to quickly find and locate suspected abnormal mucosa; on top of this, ECLI enables molecule-specific functional imaging for accurate identification and determination of GI lesions; and further relies on pCLE for high-precision "cellular-level" lesion images for optical biopsy of lesions. Through the multimodal digestive endoscopy, structural imaging and functional imaging can be accomplished simultaneously, playing the innate advantage of multimodal information fusion diagnosis and facilitating the identification of early-stage tumors.

In this clinical trial, patients with colorectal lesions who underwent PET-CT in Xijing Hospital were enrolled. Multimodal digestive endoscopy, combination of high-definition white light endoscopy, ECLI and pCLE, was used to perform for each patient's colorectal lesion. ECLI images were compared with PET-CT images, and pCLE images were compared with lesion histopathology, which evaluate the actual imaging effect of multimodal digestive endoscopy in human.


Eligibility Criteria:
Inclusion Criteria:

1. Age \>18 years old.
2. Clinical diagnosis of colorectal cancer, colorectal polyps, colorectal adenomas and enteritis.
3. No allergy to relevant imaging agents.
4. Person who is able to understand and sign the informed consent form.
5. Person who is willing to participate in this experiment.

Exclusion Criteria:

1. Patient who has been treated for colorectal lesions (endoscopic treatment, surgery , targeted therapy, and radiotherapy, etc.)
2. Patients with severe, progressive, or uncontrolled diseases of the kidneys, liver, blood, gastrointestinal tract, endocrine system, lungs, heart, or nervous system.
3. Women who are pregnant or breastfeeding.
4. Person without personal freedom and independent civil capacity.
A Study Assessing Rocatinlimab in Combination With Topical Corticosteroid and/or Topical Calcineurin Inhibitors in Adult Participants With Moderate-to-severe Atopic Dermatitis (AD)

The coprimary objectives of the study are to:

* evaluate the efficacy of rocatinlimab in combination with topical corticosteroid and/or topical calcineurin inhibitor (TCS/TCI), compared with placebo in combination with TCS/TCI at Week 24, assessed using Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD™).
* evaluate the efficacy of rocatinlimab, in combination with TCS/TCI, compared with placebo in combination with TCS/TCI at Week 24, assessed using Eczema Area and Severity Index (EASI).


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years with a diagnosis of AD according to the AAD (American Academy of Dermatology) Consensus Criteria (2014) present for at least 12 months
* History of inadequate response to TCS of medium or higher potency (with or without TCI)
* EASI score ≥16
* vIGA-AD score ≥3
* ≥10% body surface area (BSA) of AD involvement
* Worst pruritus numerical rating scale ≥ 4

Exclusion Criteria:

* Treatment with a biological product within 12 weeks or 5 half-lives, whichever is longer, prior to Day 1
* Treatment with any of the following medications or therapies within 4 weeks or 5 half-lives, whichever is longer, prior to Day 1:

  * Systemic corticosteroids
  * Nonbiologic, non-targeted Systemic immunosuppressants
  * Phototherapy
  * Janus kinase inhibitors
* Treatment with any of the following medications or therapies within 1 week, prior to Day 1:

  * TCS
  * TCI
  * Topical phosphodiesterase type 4 inhibitors
  * Other topical immunosuppressive agents
  * Combination topical agents including TCS of any potency or TCI, PDE4 inhibitors, or other topical immunosuppressive agents
Evaluation of Anti-Xa Levels in Surgery Patients Receiving Weight-based Heparin

The purpose of this study is to determine if weight-based heparin infusions at a rate of 10 units/kg/hour are sufficient to maintain a target anti-Xa of 0.1-0.35 IU/mL for VTE prophylaxis in patients undergoing microvascular surgery. Additionally, a pilot protocol has been developed to titrate these heparin infusions to ensure patients have sufficient VTE prophylaxis. All patients will be enrolled in the observational arm of the study and receive anti-Xa level monitoring. Patients with out-of-range anti-Xa levels will cross over to the interventional arm of the study and receive real time heparin infusion dose adjustments per the pilot protocol. The primary outcome measured will be the percentage of patients with anti-Xa levels in the target range of 0.1-0.35 IU/mL while on a heparin infusion at 10 units/kg/hour.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing surgical procedures
* Initiation of a heparin infusion at a rate of 500 units/hour intraoperatively or postoperatively

Exclusion Criteria:

* Age \<18 years old
* Pregnant
* Incarcerated
* Mentally disabled
Safety, Tolerability and Efficacy of ISIS-GCGRRx in Type 2 Diabetes

The purpose of this study is to evaluate the efficacy, safety and tolerability of ISIS-GCGRRx in combination with metformin versus placebo + metformin


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age 18 to 75
* BMI greater than or equal to 25
* HbA1c greater than or equal to 7.5% and less than or equal to 10.5%
* Type 2 Diabetes Mellitus and on stable dose of oral metformin
* Agree to conduct home-based (fasted) blood glucose testing as directed

Exclusion Criteria:

* Clinically significant abnormalities in medical history or physical exam
* Show evidence of uncorrected hypothyroidism or hyperthyroidism hormone results
* History of renal transplantation or renal dialysis
* History of liver disease
* History of greater than 3 episodes of severe hypoglycemia within 6 months of screening
* Use of oral anti-diabetic medication other than metformin within 3 months of screening
* History of diabetic ketoacidosis
* Any other significant illness or condition that may interfere with the patient participating or completing the study
* Inability or unwillingness to comply with protocol or study procedures
Feasibility Study of a 4 Stage Bowel Obstruction Cancer Diet

Bowel obstruction is a common complication in patients with ovarian, peritoneal and bowel cancer due to a mass or spread of disease, causing narrowing to the gut, as these cancers can grow on the bowel surface. Certain foods may lead to symptoms such as pain, bloating, feeling full, feeling sick, vomiting and difficulty passing a bowel motion.

There is limited evidence to establish the best diet to follow when someone is diagnosed with the risk of bowel obstruction and is experiencing symptoms after eating and drinking.

The Dietitians at the Royal Surrey have developed a 4 stage bowel obstruction diet which they have been using with patients for 3 years. The 4 stages are clear fluids, all thin liquids, low fibre soft smooth diet, low fibre soft sloppy diet. Depending on the severity of symptoms and the risk of a blockage, patients are asked to follow a certain stage of the diet. They are advised to move up and down the stages as symptoms improve or get worse.

This feasibility study aims to investigate if the diet can be used and is effective in clinical practice. The objectives are to see if this diet is easy to follow, can reduce symptoms of bowel obstruction, can improve quality of life, and reduce admissions to hospital because of bowel blockages.

Patients at risk of bowel obstruction from colorectal or ovarian cancer are eligible to participate. They will remain in the study for a period of 4 weeks, during which time they will be asked to complete a diet diary and 3 questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age
* Able to tolerate oral diet
* Confirmed diagnosis of SBO due to underlying malignancy to include:

  1. Patients with colorectal or gynaecological cancers with primary or secondary tumour in situ, undergoing cancer treatment or supportive care.
  2. Patients diagnosed with advanced inoperable cancers of colorectal or gynaecological origin
* Presenting in outpatient clinics or admitted from A\&E with a minimum of 2 symptoms of SBO including: abdominal pain, bloating after eating, early satiety, nausea, vomiting
* Capacity to give informed consent

Exclusion Criteria:

* Patients under 18 years of age
* No symptoms of bowel obstruction
* Have not already been given advice to follow the 4 stage bowel obstruction diet
* Unable to tolerate oral diet i.e. enterally or parenterally fed
* Unable to provide capacity to give informed consent
* Unable to read and communicate in the English language
Treatment of Keratoconus With PALK Versus PK

The purpose of this study is to evaluate the visual results of patients with keratoconus treated with one of two techniques: penetrating keratoplasty (PK) vs. pachymetry and Excimer laser assisted lamellar keratoplasty (PALK).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of keratoconus grades III or IV in the Amsler Krumeich classification.
* Need of surgical procedure
* No endothelial scar
* Best corrected visual acuity \<20/40
* Contact lens intolerance
* Imagenological map pachymetric acquisition over 90% at 9 mm corneal diameter

Exclusion Criteria:

* Contraindication for any of the techniques evaluated.
* Requiring additional surgical procedures.
* Diagnostic of other ectasia that were not primary keratoconus.
Polypill For Prevention of Cardiovascular Disease

The purpose of this pilot study is to provide data on the feasibility of conducting a large clinical trial on the polypill (combination of aspirin, angiotensin converting enzyme inhibitor, thiazide diuretic, and statin) for primary prevention of cardiovascular disease (CVD). We hypothesized that A "polypill" comprising the aforementioned four components would significantly reduce the estimated 10-year total CVD risk score with high adherence and no significant increase in adverse effects compared to the standard practice.

This is an open-label, parallel-group, randomized clinical trial comparing a Polypill to Standard Practice (defined as usual care administered to patients with similar conditions). Approximately 200 participants will be recruited from three sites in Sri Lanka: The National Hospital of Sri Lanka, Colombo; Teaching Hospital, Kegalle, and Teaching Hospital, Kandy. Subsequent to granting written informed consent, patients will undergo screening and baseline evaluation to confirm eligibility, followed by randomization to the Polypill or to the Standard Practice study arm. Patients receiving either intervention will return for a total of three monthly clinic visits.

Physician acceptability will be evaluated through a five-question survey will be mailed to a random sample of physicians from the participating clinical sites and to the Council of General Practitioners in Sri Lanka.

Patient acceptability will be measured in participants who will complete the study as well as those who will be screened but not eligible

Eligibility Criteria:
Inclusion Criteria:

* Estimated 10-year total CVD risk score \> 20%. The total CVD risk assessment will be based on the recently developed WHO CVD risk prediction charts
* No contraindication for treatment with aspirin, angiotensin converting enzyme inhibitors, low-dose diuretics, or statins
* Informed consent given

Exclusion Criteria:

* Patients with established angina pectoris, coronary heart disease, myocardial infarction, transient ischemic attacks, stroke, peripheral vascular disease, coronary revascularization and/or carotid endarterectomy Left ventricular hypertrophy (on ECG) or hypertensive retinopathy (grade III or IV)
* Patients with secondary hypertension
* Patients with diabetes type 1 or 2 with overt neuropathy or other significant renal disease.
* Known renal failure or impairment
* Atrial fibrillation
* ALT \> 1.5 times the upper limit of normal
* History of liver cirrhosis or hepatitis
* History of recent gastrointestinal bleeding (within the last year)
* Women in child bearing period
* History of life-limiting diseases or events
* Unwillingness to sign informed consent.
Mindfulness Based Dementia Care Study

Mindfulness based stress reduction (MBSR) refers to a particular type of attention focused on the present moment, non-judgmental awareness, and acceptance of that experience with openness and curiosity. Mindfulness training was designed to enhance the range and use of coping skills, decrease levels of stress, improve mood, and reduce tendencies to react in maladaptive ways 1-3. Investigators are evaluating a new program, called the Mindfulness Based Dementia-Care (MBDC) in caregivers (CG) for dementia, which combines the traditional approaches with education. The overall objective of this study is to evaluate the program and explore the potential benefits of the Mindfulness Based Dementia-Care (MBDC) program. Investigators are conducting a prospective, pre-post, observational study with members participating in the MBDC program.


Eligibility Criteria:
Inclusion Criteria:

* Must be ages ≥ 18 years
* Must be able to read and understand English
* Participant of the Mindfulness Based Dementia Care (MBDC) Program

Exclusion Criteria:

* There is no exclusion criteria for this study
ESBA105 in Patients With Severe Dry Eye

The purpose of this study was to evaluate the efficacy of ESBA105 over vehicle in reducing the ocular symptoms of dry eye disease, as measured by a mean global Visual Analog Scale (VAS) discomfort score.

Following Run-In, patients qualifying for treatment were randomized 2:1 to receive ESBA105 (experimental group) or Vehicle (control group) for 4 weeks. Patients not qualifying for treatment (based on global VAS discomfort score), were discontinued from the study.

Eligibility Criteria:
Inclusion Criteria:

* Ongoing physician diagnosis of dry eye for at least 6 months.
* Use of artificial tears, gels, lubricants, or re-wetting drops on a regular basis.
* Experience persistent ocular discomfort.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Contact lens wearers.
* Severe Sjogren's Syndrome.
* History of corneal surgery including refractive surgeries.
* Intraocular surgery within 6 months of Visit 1.
* Intraocular or periocular injection within 6 months of Visit 1.
* Lid function abnormalities.
* Use of steroids, tetracycline, doxycycline, etc., within 30 days of Visit 1.
* Any acute infectious or non-infectious ocular condition of the anterior or posterior segments in either eye within 30 days of Visit 1.
* Diseases/conditions of ocular surface associated with clinically significant scarring/destruction of conjunctiva/cornea.
* Other protocol-defined exclusion criteria may apply.
Colonization of Skin by M. Luteus Q24 Probiotic

The purpose of this study is to evaluate the skin quality improvement and colonization efficacy following the application of probiotic Micrococcus luteus Q24 (BLIS Q24) to the face from a serum format in healthy adults.

This is a randomized double-blind baseline controlled pilot study with no crossover for the assessment of any changes to the microbial make-up of the skin (The local skin microbiome), detection of colonization by the probiotic bacterium (BLIS Q24) on the skin and to evaluate the changes in skin quality parameters following topical application of probiotic in a serum format.

Eligibility Criteria:
Inclusion criteria:

1. In general good health 18 - 80 years of age.
2. Practice good general body hygiene.

Exclusion criteria:

1. Have a history of autoimmune disease or are immunocompromised (have a weakened immune system).
2. Are on concurrent antibiotic therapy or regular antibiotic use within the last 1 week.
3. People with allergies or sensitivity to dairy.
4. People with an open wound on the Blis Q24 application sites.
Changes of Angle Kappa After Implantation of Multifocal Intraocular Lenses

The purpose of this study is to evaluate possible changes of angle kappa after multifocal intraocular lens implantation. Presumable influencing factors of postoperative visual axis shift (ie. biometric parameters of the eye) are investigated to determine the degree and direction of angle kappa alterations.

The purpose of this study is to evaluate changes of angle kappa after multifocal intraocular lens implantation.

During cataract surgery Medicontur Bi-Flex 677MY IOL and Alcon Acrysof Restor SN6AD1 IOL are implanted. Optical biometry is carried out for IOL calculation and to measure axial length and angle kappa. Three months after surgery biometry is repeated, IOL position and angle kappa are measured using Scheimpflug-camera.

Eligibility Criteria:
Inclusion Criteria:

* Patients with age related cataract and presbyopia

Exclusion Criteria:

* Patients with previous ocular surgery, trauma, active ocular disease, poorly dilated pupils, or known zonular weakness and corneal astigmatism \>1.5 diopters were excluded from the study.
A Study of the Impact of Head Position on Foot Pressure in Stance

When examining a subject in quiet stance from the side, the leg segment is usually seen to be oriented upwards and forwards by about 5°; the knee may be flexed by a few degrees, the shoulders are behind the great trochanter and the head is held forwards. The forward head position moves the center of gravity forwards and thus may increase pressure under the forefoot. Conversely, moving the head backwards should be accompanied by an increase in pressure under the heel and thus decreased pressure under the forefoot.

The study's objective is to study the influence of alignment of the head with the back (i.e. a rearward head position) and head rotation on the foot pressure distribution (measured using a foot pressure platform).


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 30
* Social security coverage
* Ability to understand the study's objectives, procedures and risks and to provide informed, written consent

Exclusion Criteria:

* Past or concomitant infectious or cancerous diseases of the spine
* Vertebral osteosynthesis
* Acute neck or arm pain
* Limb trauma in the previous 12 months
* Acute leg pain
* Neuropathic disease or the sequelae of neuropathic disease of the legs
* Myasthenia gravis
* Central nervous system disorders
* Inner ear problems
* Subjects under legal guardianship
* Known pregnancy
* Simultaneous participation in another biomedical research study of a drug or medical device.
ANTERO-6 Cine-MRI Study

Previous research by TARGID (KU Leuven) has demonstrated the feasibility to assess gastric content volume by means of magnetic resonance imaging (MRI) while simultaneously evaluating gastric motor function by means of an isovolumetric balloon technique. This and other research concluded that in general, the motility readout of the isovolumetric balloon is associated with gastric contractions.

However, the exact relation between individual gastric contractions and individual intraballoon pressure waves remains incompletely understood.

Simultaneous assessment of gastric motility by means of an isovolumetric balloon and dynamic cine-MRI can validate that slow, high-amplitude intraballoon pressure waves are indeed induced by gastric muscle contractions. This evaluation might also enable us to attribute artefacts present in the pressure signal to physiologic processes such as cardiac, respiratory, intestinal and whole-body movements.

To date substantial uncertainty exists on the optimal procedural approach to evaluate gastric motility simultaneously with cine-MRI and the isovolumetric balloon.

The aim of this pilot study is to verify the feasibility of a several aspects of a larger confirmatory study protocol. This includes the evaluation of contrast of the balloon catheter on MRI (this would omit the need for radiographic confirmation), timelines, practical hurdles, analysis procedures and data management.


Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent
* At least 18 years old
* Male
* BMI between and including 18 and 30
* Understand and able to read Dutch
* In good health on the basis of medical history

Exclusion Criteria:

* Using any medication that might affect gastric function or visceral sensitivity
* Known / suspected current use of illicit drugs
* Known psychiatric or neurological illness
* Any gastrointestinal surgery that could influence normal gastric function in the opinion of the Investigator
* History of heart or vascular diseases like irregular heartbeats, angina or heart attack
* Nasopharyngeal surgery in the last 30 days
* History of thermal or chemical injury to upper respiratory tract or esophagus
* Current esophageal or nasopharyngeal obstruction
* Known coagulopathy
* Known esophageal varices
* Metal or other MRI incompatible implants
* Contra-indications for MR (checked by MR safety questionnaire)
* Claustrophobia
The Effects of Board Game in Learning Medication Knowledge Among Nursing Students

Background: Maintaining patient safety is one of the primary tasks of a professional nurse. Correct identification of medicine, understanding of pharmacological mechanisms and side effects are the basic academic knowledge that each nurse must possess. Therefore, it is an important duty for nursing teachers to teach students the knowledge of drugs and use them correctly in clinical practice. In this way, the safety of patients can be guaranteed and the quality of care can be improved. Board games have been used for study in different subjects, and they all have visible effects. Their competitive and entertaining qualities make learning more interesting and allow students to learn in a pleasant atmosphere. Therefore, the purpose of this study is to examine the effectiveness of using board games to teach medication knowledge to nursing students.

Methodology: This is a randomized controlled trial study. Convenience sampling will be applied in one university in Northern Taiwan.It is expected that 60-100 participants will be recruited and randomly assigned to the experimental group and comparison group by computer. The experimental group will use board game to learn medication, while the comparison group will be taught in a traditional way. The questionnaires will be conducted before the intervention, after the intervention, and one month later. The time for completing questionnaire is about 5\~15 minutes. The questionnaires include demographic information, medication knowledge questionnaire, and learning satisfaction questionnaire. This study will use SPSS 22.0 software for data analysis, including frequency, percentage, mean, standard deviation, t-test, chi-square, and generalized estimation equation (GEE).

Expected results: This study will be able to understand the effects of board games in learning medication among nursing students.


Eligibility Criteria:
Inclusion Criteria:

Nursing student The student who has not yet taken a practicum course

Exclusion Criteria:

The student who had already taken a pharmacology course or is taking a pharmacology course.