cyrilzakka/clinical-trials huggingface dataset:
Timing of Meal Insulin Boluses for Optimal Postprandial Glycemic Control in Type 1 Diabetes

Blood glucose levels in patients with type 1 diabetes tend to peak after eating a meal due to the delayed action of insulin when compared to carbohydrate absorption from food. It is the hypothesis of the investigator that administering the insulin for a meal 20 minutes before the meal will result in lower blood glucose peaks compared to administration of insulin immediately before or 20 minutes after starting to eat.

All subjects will eat the same meal on three different occasions. Insulin will be administered at one of the three times at each visit.

Subjects enrolled in this study will be between the ages of 12 and 30 years inclusive. All subjects will be on an insulin pump and use carbohydrate counting as their method for insulin dosing at a meal.

Subjects in this study will complete three study visits lasting from approximately 8:30am until 1:30pm. At each visit, the subject will eat the same frozen breakfast meal. Subjects will be supplied with the same insulin to maintain consistency between visits and between subjects.

Insulin will be administered at different times, depending upon the randomization group assigned to the participant. The three different times the insulin will be given is either 20 minutes before the meal, immediately before the meal and 20 minutes after the meal. All subjects will complete all three insulin bolus times. Blood glucose will be measured by fingerstick every 30 minutes until the completion of the visit.

Eligibility Criteria:
Inclusion Criteria:

* 12 to 30 years of age, inclusive
* Clinical diagnosis of T1D and using daily insulin therapy for at least 1 year
* Using carbohydrate counting to dose meal time insulin
* HbA1c value upon enrollment greater than 6.0% and less than 12.0%
* Using CSII therapy for diabetes management for at least three months
* Able and willing to give informed consent/assent to participate
* No expectation that the subject will be moving out of the area of the clinical center during the study
* Willing to consume the same standard frozen meal on all three visits

Exclusion Criteria:

* The presence of a significant medical disorder that in the judgment of the investigator will affect the wearing of the CGMS sensors or the completion of any aspect of the protocol
* Being unable or unwilling to give informed consent
* Having documented hypoglycemia unawareness
* An episode of severe hypoglycemia (seizure or loss of consciousness) or of ketoacidosis in the past six months
Perspectives of Family Carers of Older People From Turkish and Moroccan Origin in Belgium on Advance Care Planning

In this study, we will explore the perspective of family carers of older adults from Turkish and Moroccan origin in Flanders and Brussels, Belgium, concerning advance care planning (ACP), more specifically concerning their knowledge about ACP, their experiences with and their points of view on ACP for their family member and their own preferences regarding how to be involved in the process of ACP for their relatives.

Whether or not someone wants to engage in ACP, is often the result of a complex interplay of meanings, events, processes and assumptions constructed by the patient and is best approached by qualitative methods. Semi-structured interviews will be used in order to explore the respondents' knowledge about and experience with ACP, also their views concerning ACP for their relatives and how do they prefer to engage in the process of ACP for their relatives will be explored.

Eligibility Criteria:
Inclusion Criteria:

* Family carers of older adults with a Turkish or a Moroccan origin who have participated in our previous studies with NCT03930823 and NCT04335214, as identified by the older adults as the most significant family carer. Older adults in our previous studies were men and women, all 65 years and older and living in Flanders and Brussels.
* and who live in Belgium and are 18 years or older and fluent in French or Dutch language.
* and who have also given informed consent to participate in this qualitative interview study

Exclusion Criteria:

* None
Beijing Osteoporosis With Neurological Disorders in Epigenetic Changes Study

Epigenetic modification refers to the change of heritable gene expression occurring in the case of unchanged DNA sequence, including DNA methylation, epigenetic modification, RNAS, chromatin modification, etc. The study found that osteoporosis (OSTEOPOROSIS,OP) with neurological disorders is very common, the risk of fracture of patients increased. It is considered that epigenetic regulation plays an important role in the occurrence and development of OP with neurological disorders. In particular, the role and molecular mechanism of epigenetic modification in OP with neurological disorders are not clear, and the results of clinical studies with different sample sizes are not consistent. (1) Two-way continuous queues,an ambispective cohort study， namely: forward-looking queue method (2017-2027) and Retrospective queue method (2007-2017) were used to understand the effect of epigenetic modification on bone mineral density, bone metabolic Biochemical Index, imaging index and fracture incidence of patients with neurological diseases in outpatients and wards, and to provide basis for further study. To observe the effects of epigenetic modification on cognitive function in two groups of patients (memory scale, life activity Energy meter (ADL) and cognitive scale (MMSE) and clinical physical examination and neuropsychological test, etc., Bone correlation detection (Lumbar and hip bone mineral density T-score, imaging index, bone Metabolic Biochemical Index and fracture incidence index) Influence. Multivariate stepwise regression analysis was performed to eliminate confounding factors, such as age, body mass index (BMI), related risk factors, and internal diseases. The patient's previous information is also analyzed; (2) To find meaningful epigenetic modification from clinical data, the molecular mechanism was studied in depth, and the imaging indexes (X-ray, CT, MRI) and Bone marker Index (serum osteocalcin (OC), total I-type procollagen peptide (TP1NP) were found in the study. Type I collagen hydroxy-terminated peptide beta degradation product (Β-CTX)). The relationship between the reaction epigenetic modification and cognitive function index, image and bone markers and the mechanism model were further established.


Eligibility Criteria:
Inclusion Criteria:

* Normal hearing, vision, and pronunciation
* DEXA examination

Exclusion Criteria:

* Mental retardation
* Blindness, deafness, and dumb
* Severe schizophrenia
Spanish Registry of Digestive Tumours RETUD

The aim of this observational study is to assess the current state of digestive tumours in Spain. By doing so, it seeks to enhance the quality of care, optimize the diagnosis and treatment of digestive tumours, and identify opportunities for improvement that can benefit patients.

The study will investigate the epidemiological, biological, and clinical characteristics of digestive tumors diagnosed in patients aged 18 and older across healthcare centres in Spain. It also aims to generate knowledge and scientific evidence for events and situations that may impact on patients with digestive tumours (e.g. COVID-19 coronavirus pandemic).

Furthermore, subject to the patient's consent, biological samples may be collected for use in translational research projects and for the identification of molecular markers that may be useful in healthcare decision-making.

Data will be collected ambispectively, recording those patients who were diagnosed with digestive tumours before the start of the study (from 2017) and also those who are diagnosed after the start of the study.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients ≥18 years old diagnosed with oesophageal cancer, gastric cancer, pancreatic cancer, hepatocarcinoma, gallbladder and bile duct cancer, cancer of the small intestine, appendix and gastrointestinal stroma, colorectal cancer, anal canal cancer or digestive hereditary cancer.
* Written informed consent available.

Exclusion Criteria:

* Patient for whom, for whatever reason, it is not possible to know or obtain the information necessary to complete the data collection base.
Turkish Version of LIFE Habits Assessment

Cerebral Palsy (CP) is the most common cause of physical disability in children, is a non-progressive neurological impairment resulting from an injury in the developing brain and causing various problems related to sensory, perception, cognition, and movement. This problems leads activity and participation levels of the children with CP. In the literature various assessment tools developed for assessing participation. Assessment of Life Habits (LIFE-H) questionnaire is one of the assessment tools that examines activities of daily life and participation in detail. The scale is originally in French but English and German versions are also available. The aim of this study is to translate the scale to Turkish and to determine validity and reliability of Turkish version of Life Habits questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* To be diagnosed as cerebral palsy

Exclusion Criteria:

* Children whose family didn't accept to participate to study
The Effect of Nurse Navigation Program on Lung Cancer Patients

The study aims to determine the effect of the nurse navigation program (LungCaNN), which is performed in line with the supportive care needs of newly diagnosed non-small cell lung cancer patients, on the level of anxiety-depression, adherence to the disease, and quality of life.

The study was designed as a randomized study with a control group. This study will be carried out with a total of 84 NSCLC patients, 42 of whom were in the intervention group and 42 in the control group, whose treatment was started in Akdeniz University Medical Oncology Outpatient Clinic and met the inclusion criteria of the sampling. Nurse navigation program will be applied for 12 weeks from the diagnosis of NSCLC patients in the intervention group. The intervention protocol of the study is abbreviated as "Lung Cancer Nurse Navigator" \[LungCaNN\].

Within the scope of the LungCaNN program, face-to-face patient education, patient education booklet, face-to-face, and telephone navigation initiatives were planned. Patient Identification Form, Depression Anxiety Stress Scale (DASS 21), Chronic Disease Adjustment Scale, EORTC QLQ 30 Quality of Life Scale-/ LC-13, and Navigation and Interview Steps Form will be used to collect data.


Eligibility Criteria:
Inclusion Criteria:

* Know how to read and write No hearing or speech problems Be able to use the phone The primary medical diagnosis is non-small cell lung cancer Karnofsky Performance Scale score of 70% or higher Patients with a stress thermometer of 4 and above At most six weeks past the date of diagnosis

Exclusion Criteria:

* Patients with cognitive problems Expected life expectancy is less than three months
Comparison of Methotrexate (MTX) and the VIBEX™ MTX Device

Relative Bioavailability Comparison study

A Phase 2, Open-Label, Randomized, 3-Way Crossover Study to Compare the Relative Bioavailability of Oral Methotrexate and the VIBEX™ MTX Device in Adult Subjects With Rheumatoid Arthritis

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients ≥18 years of age, diagnosed with Rheumatoid Arthritis

Exclusion Criteria:

* Pregnant females
* Any other clinically significant disease or disorder which, in the opinion of the investigator might put the subject at risk
Trajectory Analysis of NLR and Its Association With Efficacy of Immunochemotherapy in ESCC.

Conduct a retrospective and prospective study to confirm the association between blood cells counts and the efficacy and safety in immunochemotherapy in patients with advanced esophageal cancer.

Studies have already demonstrated the feasibility of prognostic role of protein biomarkers change during the treatment trajectory of patients in several carcinoma,However, no study focused on the value of trajectory analysis of blood cells counts of Immunochemotherapy in patients with advanced esophageal cancer.

The investigators plan to analyze the dynamic change of blood cells counts longitudinally from preoperation to long term follow-up in advanced esophageal cancer and predict the efficacy and safety of immunochemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed esophageal squamous cell carcinoma
* Potentially resectable esophageal squamous cell carcinoma at first diagnosis (cT1-4a N1-2 M0, cT3-T4a N0M0)
* Treatment-naive
* Expected life span \> 6 months
* Aged 18 - 75 years old
* Adequate organ functions
* Performance Status (PS) 0-2
* Participants are fully informed about the whole study and are willing to sign the informed consent

Exclusion Criteria:

* Previous history of thoracic surgery or radiation
* Cervical or multi-origin esophageal cancer
* Known or suspected experimental drug allergy
* Pregnant or lactating women
* Esophagomediastinal fistula
* Peripheral neuropathy
* Previous cancer history other than esophageal cancer
* Severe organ function deterioration that can not tolerate neoadjuvant therapy
* Previous autoimmune diseases
* diabetic history \> 10 years
* interstitial pulmonary disease, non-infectious pulmonitis
* Active type B hepatitis
* Any other conditions that may affect patients' safety and compliance
Clinical Outcomes of Implantationof Black Diaphragm Intraocular Lens in Complete Aniridia and Aphakia Due to Posttraumatic Eye Rupture

Purpose: To assess long-term outcomes of implantation of black diaphragmintraocular lens (BD IOL) in postraumatic aniridia and aphakia due to eye rupture.

METHODS: This is retrospective consecutive case series of 14 eyes with post-traumatic complete aniridia and aphakia treated withscleral fixation of BD IOL with. Measurements included ophthalmological comorbidities, best corrected visual acuity (BCVA), complications, and postoperative interventions. The average postoperative follow-up period was 36 months.


Eligibility Criteria:
Inclusion Criteria:

post-traumatic complete aniridia and aphakia

Exclusion Criteria:

active ocluar inflammation or infection
Vitamin Deficiencies and Suppletion in Morbid Obesity

The purpose of this study is to evaluate the most effective treatment for patients who underwent a Roux-en-Y gastric bypass and developed postoperatively a vitamin B12 deficiency.

Vitamin B12 deficiency accounts up to 23-64% bariatric surgery. The investigators purpose is to evaluate the most effective treatment for vitamin B12 deficiency in patients who underwent a Roux-en-Y gastric bypass.

Daily oral use of vitamin B12 tablets are may be as effective as vitamin B12 injections.

Eligibility Criteria:
Inclusion Criteria:

* Vitamin B12 deficiency: \<200 pmol/l
* Vitamin B12 deficiency 6-12 months after surgery
* All patients underwent a Roux-en-Y gastric bypass

Exclusion Criteria:

1. Creatin \>150micromol/L
2. Liver enzymes \>2 times upper limit
3. Other bariatric operations
4. Intercurrent diseases
5. Gastro-intestinal diseases
6. Psychiatric disease
7. Medicines which influences bone density
8. Pregnancy
Teen-to-Teen Videos to Improve Electronic Medical Record Portal Knowledge and Personal Health Information Engagement

The goal of this clinical trial is to compare whether videos help teens better understand medical topics. The main questions answered in this trial are:

1. whether videos can improve teen knowledge about electronic medical record portals
2. whether videos can improve teen knowledge about general health issues

Participants will answer surveys and watch videos as part of this study.

Investigators performed a randomized controlled trial of education videos addressing one of two topics: A) electronic medical record portals and information shared therein and B) general adolescent health issues among adolescents and young adults with inflammatory bowel diseases. Investigators evaluated the efficacy of each in increasing participant knowledge in that arena.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Inflammatory Bowel Disease
* English proficient

Exclusion Criteria:

- Unable to give consent
Efficacy of Metronidazole Versus Metronidazole and Rifampin in CDAD Treatment

What is the difference between the use of one drug (Oral Metronidazole) versus the use of this same drug combined with another drug (Rifampin) in treatment of bacteria and infection-associated diarrhea in patients? This infection is an important cause of morbidity and mortality in both the community and hospitals, and the leading cause of hospital and chronic facility-acquired diarrhea. Research is important for the treatment of this infection. Patient care with use of two medication treatment regimens will be studied.

Clostridium difficile infection contributes to both community and hospital acquired morbidity and mortality. Metronidazole alone is usually considered the drug of choice, however, frequent relapses occur at a rate of 10-40%. The purpose of this study is to address the use of a combined drug regimen treatment (Metronidazole and Rifampin) for the treatment of CDAD. These drugs used together have been successful. Objectives are to determine the time (days) to resolution of symptoms in each treatment arm; to measure clinical relapse rates; and to assess adverse reactions related to treatment.

Eligibility Criteria:
Inclusion Criteria:

* Inpatients + outpatients diagnosed with CDAD based on SHEA definition \[Laboratory confirmation for presence of C.difficile toxin using enzyme immunoassay and no other etiology for diarrhea + Presence of 1 or more of the following: diarrhea (6 watery stool over 36 hours or 3 unformed stools in 24 hours for at least 2days), pseudomembranes at endoscopy\].

Exclusion Criteria:

* Age \< 14 yr
* Known hypersensitivity to metronidazole, rifampin
* Receiving medication(s) with potential significant drug interaction with rifampin
* Active liver disease as indicated by ALT \> 200 U/L
* Adynamic ileus
* Toxic megacolon
* Pregnancy
Sonobiopsy for Noninvasive and Sensitive Detection of Glioblastoma

This clinical study to evaluate sonobiopsy is significant because sonobiopsy will fundamentally enhance the clinician's insight into the molecular features of an intracranial lesion to tailor treatment approaches and optimize outcomes. In addition to the standard diagnostics of anatomic imaging and surgical histology, sonobiopsy has the potential to become the third pillar for brain tumor management by radically advancing the ability to easily and regularly acquire tumor genetic and molecular signatures. This enhanced capability will have a dramatic impact on patient survival and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Must be newly diagnosed with a lesion in the brain with imaging characteristics consistent with glioblastoma multiforme. Scan must have occurred no more than 28 days prior to enrollment.
* Lesion must be \> 3 cm in maximal dimension on MRI.
* Lesion must be in the supratentorial space within 5 cm of the cortical surface.
* Lesion must be gadolinium enhancing.
* Low grade tumors and metastatic tumors
* Recurrent brain tumors and/or radiation necrosis
* Must be planning to undergo surgical resection of the tumor.
* Must be at least 18 years old.
* Patients with recurrent GBM who are planning to undergo surgical resection or laser ablation of the recurrent tumor. Recurrence must be confirmed on MRI performed no more than 28 days prior to enrollment.

Exclusion Criteria:

* Contraindication to MRI.
* Previous cranial surgery.
* Previous history of cancer and/or cancer treatments.
* Coagulopathy within 14 days of enrollment defined as PT/PTT outside of normal parameters and platelets \< 100,000/mcL.
* Physical skull defect of any kind.
* Ferrous material in the scalp or skull.
* Scalp or skin disease that limits contact with the ultrasound probe.
* Enrolled in another clinical trial where intervention is administered prior to surgery.
* Known hypersensitivity to polyethylene glycol.
* Known unstable cardiopulmonary condition (e.g. acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, serious ventricular arrhythmias).
Comparative Effectiveness of Hot Versus Cold Snare Polypectomy of Small Colorectal Polyps

This study aims to investigate the comparative effectiveness between polyp removal with or without electrical current. The investigators want to include 600 polyps in the trial.

It is known that polyps have the potential to develop to cancer if left in situ, but the investigators do not know the best way to remove them completely.

In this study the investigators want to compare to widely used methods for polyp removal; hot and cold snare polypectomy. There has not been performed any big studies on this subject earlier, but current knowledge indicates that hot polypectomy (i.e. with use of electrical current) is somewhat better with regard to complete resection of polyps compared to cold polypectomy (without electrical current).

In this project the patients will be randomized to either hot or cold polypectomy. The investigators will distribute videos of how the polypectomies should be performed, and a gastroenterologist in the project group will instruct the doctors examining the patients to make sure that everyone performs polypectomy according to current guidelines.

The study is designed as a non-inferiority trial.

Eligibility Criteria:
Inclusion Criteria:

* Outpatient colonoscopy
* Signed, written informed consent
* At least one flat/sessile polyp sized 4-9 mm identified during colonoscopy

Exclusion Criteria:

* Implanted cardiac electro converter
* Severe comorbidity (NYHA 3-4)
* Known coagulopathy (INR \> 1,8) or resent use of any of the new oral anti-coagulant medications
* Platelet count \< 100
* Resent use of clopidogrel or other non-acetylsalicylic acid platelet inhibitor (Last dose \< 5 days before the procedure)
* Previous biopsy or attempt of polypectomy of the polyp considered for inclusion in the trial