cyrilzakka/clinical-trials huggingface dataset:
Fibrin Glue After ESD for High Risk Patients of Bleeding

It is a prospective randomized controlled study to look for effectiveness of fibrin glue to prevent bleeding in high-risk patients after endoscopic submucosal dissection in gastric neoplasm.

Investigators want to observe the bleeding rate after endoscopic submucosal dissection for gastric tumors in the high-risk group of bleeding (the size of the iatrogenic ulcer is expected to be 40mm or more, or taking aspirin, antiplatelet drugs, and anticoagulants).

After resection and hemostasis with ESD, Fibrin glue (Greenplast Q™) is applied to the iatrogenic ulcer at the end of the procedure, and the control group will not be applied.

After that, observe whether there is a difference in the bleeding rate within 48 hours and 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* ECOG performance status 0-1
* Patients scheduled to undergo ESD due to gastric tumor (dysplasia, early gastric cancer)
* Patients who are expected to have an iatrogenic ulcer size of 40mm or more after endoscopic submucosal dissection, or are taking aspirin, antiplatelet drugs, or anticoagulants
* Patients who show adequate patient compliance and have adequate geographic distance for follow-up observation.

Exclusion Criteria:

* Patients with sensitivity to cow protein or its derived ingredients
* Patients who had previously undergone partial gastrectomy
* Patients with early gastric cancer at the site previously undergoing ESD
* Patients with clinically significant cardiopulmonary disease
* Patients with active hepatitis, liver disease that is not well controlled by treatment, or severe liver disorder
* Patients with severe renal impairment
* Patients with severe bone marrow dysfunction
* Patients with severe blood clotting impairment (including hemophilia)
* Patients with serious neurological or mental illness (e.g. epilepsy or dementia)
* Patients with reported side effects of contrast media
* Pregnant and lactating women
* Patients who have not obtained the informed consent of the patient and guardian
* Patients who are inadequate for clinical trials as judged by the attending physician
MRI and Eye-tracking Predictive Markers of Cognitive Ageing

This research proposes to investigate physiological and cognitive markers of locus coeruleus (LC) neuronal integrity and function in cognitively-healthy participants over 60 years old. The locus coeruleus is a brainstem nucleus, sole source of noradrenaline for the brain. Tau pathology appears in neurons of this nucleus, which may induce initial cognitive changes. The study aims at relating locus coeruleus markers, assessed with MRI and eye-tracking techniques, with cognitive function.

The LC is a small brainstem nucleus, sole source of noradrenaline (NA) to the brain. NA is involved in the physiological arousal response: LC neuronal activity is closely related with pupil dilation, and pupil size is now considered a reliable and easy-access biomarker of LC function. NA-dependent cognitive functions include attention, flexibility and memory, which are selectively impaired with age. Accordingly, LC-NA system dysfunction may occur and contribute to initial cognitive changes during old age.

The study will assess, in cognitively-healthy older volunteers from the INSPIRE cohort (n=100, over 60 years old), MRI and pupillometry markers of LC integrity, LC-forebrain connectivity and LC activity. We aim at investigating the relationship between LC biomarkers and cognitive status. Four experimental visits will be conducted by each participant, every 6 months over an 18-month period. Visits V1 and V4 will include MRI, eye-tracking and detailed cognitive exams. Visits V2 and V3 will include a detailed cognitive exam.

Eligibility Criteria:
Inclusion Criteria:

* INSPIRE cohort participant
* Mini-Mental State Examination score ≥ 27 on 30
* Access to a web connection from participant's or relative's home and regular use of web surfing
* Signature of the informed consent
* Affiliated to a social security scheme

Exclusion Criteria:

* Any contra-indications to MRI exam
* Ophthalmic pathology impacting eye-tracking measures
* Neurological or psychiatric pathology
* Person under guardianship or curatorship

Contraindications to MRI examination:

* Pacemaker or cardiac defibrillator
* Implanted material activated by an electrical, magnetic or mechanical system
* Haemostatic clips for intracerebral aneurysms or carotid arteries
* Orthopedic implants
* Claustrophobia

Ophthalmological pathologies impacting eye tracking measurements:

* Glaucoma
* Age-related macular degeneration
* Unoperated cataract
Effect of Acidic Vaginal pH on the Efficacy of Dinoprostone for Labor Induction

Acidification of vaginal pH has been proposed as a potential factor that could help increase the efficacy of vaginal prostaglandins in labor induction. The aim of the present randomized controlled trial is to evaluate the impact of an acidic vaginal pH on the progress of labor induction with dinoprostone (Prostaglandin E2 - PGE2) vaginal tablet.


Eligibility Criteria:
Inclusion criteria

* Singleton pregnancy
* Full term (\>37 weeks)
* Cephalic presentation
* Reactive NST (nonstress test)
* Absence of spontaneous uterine contractions
* No contraindications to vaginal delivery

Exclusion criteria

* Multifetal pregnancy
* Fetal malpresentation
* Preterm delivery (\<37 weeks)
* Advanced maternal age (\>40 years)
* Bishop score \> 7
* Fetal macrosomia ( \>4500 gr)
* Non reassuring NST (nonstress test)
* Suspected chorioamnionitis
* Previous cesarean delivery or other uterine surgery
Electronic Repositioning With Acuity and Easytrak Leads

Evaluate appropriate performance of Electronic Repositioning™ (ER) in the clinical routine, cumulative incidence of phrenic nerve stimulation (PNS) \& success rates of Electronic Repositioning (ER) to remove it, various incl. left ventricular pacing (LVP) thresholds and PNS

Bipolar leads for left ventricular pacing (LVP) such as the newly available ACUITY™ or the standard EASYTRAK™ II and EASYTRAK™ III leads from GUIDANT in combination with suitable devices for cardiac resynchronization therapy (CRT) allow for the non-invasive programming of different Left Ventricular Pacing (LVP) configurations. Hence, this Electronic Repositioning (ER) may help physicians to overcome problems in cardiac resynchronization therapy (CRT) such as ineffective biventricular pacing, high Left Ventricular Pacing (LVP) thresholds and phrenic nerve stimulation (PNS) without the need for an additional patient's operation to reposition LV leads. The ERACE study it a multi-center, prospective, non-randomized clinical study to document and evaluate appropriate performance of GUIDANT's Electronic Repositioning™ in the clinical routine with respect to the following major aspects:

avoidance of PNS and low LVP thresholds (for low battery consumption and extended device longevity) in standard cardiac resynchronization therapy (CRT)

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving their FIRST implantation of a Left Ventricular (LV) lead in combination with a CRT device with implantable cardioverter defibrillator (ICD) backup and the possibility for Electronic Repositioning™
* Patients willing (= signed written consent) and capable to participate in all procedures of the study"

Exclusion Criteria:

* Patients who will not be available for routine Follow up
* 18 years old
* Known pregnancy.
Virtual Reality Pediatric Orthopaedic Outpatient Procedures

The main objective of the study is to evaluate the use of Virtual Reality (VR) in managing pain and anxiety levels during common pediatric orthopaedic outpatient procedures which include: cast application, cast removal, hardware removal (ie. pins and screws), and botox injections.

Immediately following recruitment, demographic data and diseased related information (ie. location of cast/hardware, reason for cast/hardware placement and location and reason for botox injection) will be collected through self and/or guardian report. All data will be collected using REDCap (research electronic data capture). Using a parallel group design, patients will then be stratified by age (4-7, 8-12 and 13-18 years), gender, and procedure classifications (hardware or cast or staple or suture removal or cast application or botox injection) site of hardware or cast or staple or suture or botox injection), and reason for the procedure (trauma vs a preexisting orthopaedic condition). After randomization by the REDCap system, patients are taken into the procedure room where a questionnaire (Short STAI) is completed by the patient to collect pre-procedural state anxiety measurements. Following this, patients in the control group will receive standard of care (SOC) which allows for the technician and/or accompanying guardian to try and distract and or console the patient as they normally would. The patients in the intervention group will receive SOC with Virtual Reality (VR) interaction a few minutes before, during and following the procedure (around 5-10minutes total). During the procedure the researcher will complete an observational survey (CEMS) to assess procedural state anxiety. Upon completion, both groups will then be asked to complete a survey (Short STAI) to collect post-procedural anxiety levels and an additional survey (Wong Baker Scale) to retrospectively collect pain levels from during the procedure and their current pain levels post procedure while parent/guardians and cast technician will be asked to complete their respective satisfaction questionnaires. Following this, the child will be asked if they experienced any nausea at any point during the procedure, if they did, they will be asked to complete the BARF questionnaire to measure the amount of nausea experienced. Following completion of questionnaires, patients who were in the control group are invited to interact with the VR simulation for a total of 5 minutes. This was chosen to incentivize recruitment for the study.

SOC will consist of the technician/care provider explaining the procedure while using speech to be comforting and supportive in addition to parent/guardians being allowed to console and distract their child during the procedure.

Eligibility Criteria:
Inclusion Criteria:

* child must be between the ages of 4 and 18 years
* the parent/guardians and child are both able to speak and read English or have a translator be present for them

Exclusion Criteria:

* symptoms of respiratory or gastrointestinal infection
* visual, auditory, cognitive impairment or developmental delay
* history of seizures or epilepsy
Long Term Oxygen Therapy in Patients With Interstitial Lung Disease

Study the effect of using long term oxygen therapy in patients with interstitial lung disease and chronic hypoxia

long term oxygen can be used in patients with interstitial lung disease with hypoxia and the aim of this study is to k ow whether this will improve life style , exercise tolerance in those patients

Eligibility Criteria:
Inclusion Criteria :

* patients with ILD and hypoxia with SO2\<88 at room air and PO2 \< or equal 7.3k.pa or \< or equal 8 k.pa in presence of lower limb edema , pulmonary hypertension or polycythemia
* age group 18 : 70

Exclusion Criteria :

* Causes of chronic respiratory failure other than ILD.
The Effect of Specific Strength-Training on Tension-Type Headache in Children 9-17 Years

This study aims at examining muscle strength capacity in neck and shoulder muscles in children and adolescents with and without tension-type headache, and furthermore examining the effect of a 10 week specific strength training programme for neck and shoulder muscles compared to a multi-disciplinary approach in 10 weeks.

Frequent and chronic tension type headache are the most frequent pain illnesses in children with a prevalence of 0.5-7,6%. Frequent or daily headache leads to constraints in the child's life in relation to school and social activities.

The underlying pathophysiological mechanisms are not yet fully examined. In several studies in adults and in children it is found that the shoulder muscles are tense and tender, but it is not known whether this phenomenon is primary or secondary to tension-type headache. A decrease in muscle capacity is furthermore found in studies. We therefore aim at examining parameters for muscle function in order to compare the differences between children with and without headache, and at examining the effect of a 10 week progressive specific strength training programme on headache compared to an in time comparable multidisciplinary intervention based on lifestyle counseling.

Eligibility Criteria:
Inclusion Criteria:

* primary tension-type headache with no more than one episode of migraine pr. month

Exclusion Criteria:

* post-trauma headache
* co-morbidity
A Phase II/III Study to Evaluate the Immunogenicity, Safety and Lot-to-lot Consistency of LBVD, a Fully Liquid Hexavalent Diphtheria-tetanus-whole Cell Pertussis-hepatitis B-poliovirus-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, in Healthy Infants as Primary Series

The purpose of this study is to evaluate immunogenicity, safety and lot-to-lot consistency of LBVD in comparison to co-administration of Pentavalent vaccine and Poliomyelitis Vaccine (Inactivated) in separate injections at four weeks after completion of three-dose primary series at 6-10-14 weeks of age when administered to healthy infants

Stage 1 (Phase 2)

1. To compare the immunogenicity and safety of LBVD to the licensed Control vaccines at 4 weeks after a three-dose primary series of vaccination given at 6-, 10- and 14-week of age

Stage 2 (Phase 3)

1. To demonstrate the non-inferior immunogenicity of LBVD to the licensed Control Vaccine at 4 weeks after a three-dose primary series of vaccination given at 6-, 10- and 14-week of age
2. To demonstrate lot-to-lot consistency in the immunogenicity of three separate lots of LBVD at 4 weeks after a three-dose primary series of vaccination given at 6-, 10- and 14-week of age

Eligibility Criteria:
Inclusion Criteria:

* healthy infants from 6 weeks to 8 weeks of age (both inclusive)
* body weight ≥ 3.2 kg
* born at full term pregnancy (≥ 37 weeks)
* signed informed consent by parent(s) or legally acceptable representative(s)

Exclusion Criteria:

* Known history of Hib infection, HepB, diphtheria, tetanus, pertussis, or poliomyelitis
* Household contact or intimate exposure with a confirmed case of Hib, HepB, diphtheria, pertussis, tetanus or poliomyelitis within 30 days prior to study registration
* Known history of SARS-CoV-2 infection
* Participant's mother is HepB antigen or HIV positive
* Fever ≥ 38.0 C/100.4 F within 3 days prior to enrollment
* Vaccination history of non-study vaccines within 30 days prior to enrollment except for pneumococcal conjugate, rotavirus, HepB and Bacillus Calmette Guerin (BCG)
* Previous use of any diphtheria, tetanus, pertussis-based combination vaccine(s), Hib conjugate, poliovirus, or combination
* Received immunosuppressive agents or other immune-modifying drugs
* Previous use of blood or blood-derived products
* Any history of allergy (hypersensitivity) to any of the vaccine components
* Participation in another interventional clinical trial within 4 weeks of expected first vaccination
NT-proBNP for Evaluation of the Dyspneic Patient in the Emergency Room and the Medical Ward

The proposed study intends to evaluate the impact of the NT-proBNP assay on the diagnosis of heart failure in patients with dyspnea of unknown etiology presenting to the emergency room and admitted to the medical wards.

The proposed study intends to evaluate the impact of the NT-proBNP assay on the diagnosis of heart failure in patients with dyspnea of unknown etiology presenting to the emergency room and admitted to the medical wards.

Patients will be consented and randomized to open or blinded NT-proBNP test performed within 90 minutes in a venous blood sample.

Evaluation of the ER diagnosis and final discharge diagnosis in admitted patients will be carried out in light of the NT-proBNP results.

Eligibility Criteria:
Inclusion Criteria:

1. Acute shortness of breath of unknown etiology as presentation to the emergency room
2. Possible acute exacerbation of known heart failure

Exclusion Criteria:

None -
Inhalation of Ciclesonide for Patients With COVID-19: A Randomised Open Treatment Study (HALT COVID-19)

Randomized open label clinical trial carried out at study centers in Sweden, including Karolinska University Hospital, S:t Göran Hospital, Danderyd Hospital and Västmanlands Hospital. Patients with COVID-19 who are hospitalized with oxygen therapy are eligible for inclusion. Subjects are randomized to 14 days of inhalation with ciclesonide 360 µg twice daily or to standard of care. Primary outcome is duration of received supplemental oxygen therapy. Key secondary outcome is a composite outcome of death and received invasive mechanical ventilation within 30 days.


Eligibility Criteria:
Inclusion criteria:

* Patients 18 years of age or older who have given their written consent to participate in the study.
* Hospitalized and treated with oxygen for a maximum of 48 hours.
* Verified Covid-19: Positive sample for Sars-Cov2 RNA or a positive Sars-Cov2 antigen test from the upper respiratory tract
* Receives oxygen treatment.
* Negative pregnancy test (women of childbearing potential)
* Willing to exercise contraception categorized as "very effective" according to the Clinical Trial Facilitation Group during ongoing study treatment + 7 days (Appendix 2). (female research participant of childbearing potential)

Exclusion criteria:

* Pregnancy, breast-feeding or planned pregnancy.
* Hypersensitivity to ciclesonide or to any of the excipients.
* Concomitant medication with cortisone, ketoconazole, itraconazole, ritonavir or nelfinavir.
* Treatment with\> 8 l oxygen / min or supply of \> 50% oxygen with nasal high-flow cannula
* Ongoing palliative care or expected survival of less than 72 hours.
* Expected admission to the intensive care unit within 48 hours.
* Active or inactive pulmonary tuberculosis.
* Severe Liver Failure (Child-Pugh C)
* Diagnosed with pulmonary arterial hypertension (PAH) or fibrosis.
* Mental inability, reluctance or language difficulties that make it difficult to understand the meaning of participating in the study.
* Participates in or has recently participated in a clinical trial in the last 30 days. Previous participation in this study.
A Study to Assess Different Diagnostic Criteria of Chronic Constipation in Asia

The purpose of the study is to evaluate the differences or similarities in the results obtained with two different scoring systems for chronic constipation in Asian participants consulting in gastroenterology clinics (the Asian Neurogastro-enterology and Motility Association (ANMA) chronic constipation (CC) diagnostic tool (diagnosis questionnaire) and the ROME III diagnosis criteria (western gold standard).

This is an observational (investigators observe participants and measure outcomes without assigning a treatment), non-product specific, regional multicenter (conducted at multiple sites) and multicountry, cross-sectional (observation of all members of a population at one specific point in time), epidemiological study (study of the patterns, causes, and effects of health and disease conditions in defined populations). The study will be conducted in 3 steps. In Step 1 (screening phase), all adult participants visiting their gastroenterologist (for any condition) within a 3 month period will be screened using the ANMA screening worksheet. In Step 2A (diagnosis phase - during investigator chosen consecutive consultation days), all the eligible participants will be required to complete a combination Diagnosis Questionnaire to obtain a diagnosis of CC based on different criteria: self-defined, investigator-judgement, ANMA tool, and ROME III criteria. Details about previous examinations and demography will also be collected during Step 2A of the study, together with Patient Assessment of Constipation Symptoms (PAC-SYM). Participants with a positive response to the ANMA diagnosis tool will proceed to Step 2B. In Step 2B (documentation phase), more information about the participant will be collected using the documentation questionnaire: demography, medical history, history of CC, current symptoms of CC, comorbidities, past and current medications for CC. The Patient Assessment of Constipation-Quality of Life (PAC-QOL) scale will be used to assess participant's satisfaction with their current treatment. Approximately 2000 participants will be screened to yield approximately 400 participants with suspected chronic constipation for whom the Diagnostic and Documentation Questionnaire will be filled in. Safety evaluations will include assessment of adverse events and special reporting situations such as pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* Participants who have at least 1 of the symptoms listed in the Screening Worksheet and the symptom has been present for at least 3 months
* Participants have signed the informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to complete all the questions on the questionnaires

Exclusion Criteria:

* Participants judged by the investigator to suffer from chronic constipation that is drug-induced or with secondary causes eg, endocrine, metabolic or neurological disorders, surgical obstruction, megacolon/megarectum, a diagnosis of pseudo-obstruction and organic disorders of the large bowel
* Pregnant female participants
Cue-Based Vs. Clinician-Driven Feeding in Very Low Birthweight Infants

In this parallel-group randomized controlled trial, very low birthweight infants will be randomly assigned in a 1:1 ratio to either cue-based (intervention group) or clinician-driven feeding (control group). For infants in the intervention group, Speech therapists and nurses will use their cue-based assessment training to aid in clinical management of oral feeding. For infants in the control group, clinicians caring for these infants will define the feeding plan based on their daily assessment.


Eligibility Criteria:
Inclusion criteria:

* Birthweight \< 1500 grams
* Gestational age between 28 and 31 weeks of gestation
* Full enteral feeding established before 32 weeks of postmenstrual age (PMA)
* Oral feeding initiated before 33 weeks PMA.

Exclusion criteria:

* Major congenital/chromosomal anomalies,
* Patent ductus arteriosus causing significant cardiovascular symptoms
* History of necrotizing enterocolitis stage 2 or greater