cyrilzakka/clinical-trials huggingface dataset:
Usability of myfood24 in Clinical Populations

Many patients would benefit from dietary/nutritional support to better manage their conditions but evaluating current intake in relation to personal targets is labour-intensive and often does not feature as part of clinical consultations.

Primary objective: test usability and acceptability of 'myfood24 Health' for monitoring dietary intake in a group of patients.

Recruit 60 gastroenterology surgery patient (Leeds) and 60 Tier 3 Weight Management patients (30 Leeds/ 30 York).

Randomise to 3 groups

1. usual care
2. myfood24Health
3. myfood24Health plus personalised feedback 'diet optimisation engine' which suggests changes to amounts or types of foods

During a 2-month follow-up, patients in group 2 or 3 will be asked to record daily diet in myfood24, including weekend and weekdays and use it a minimum of 4 times.

HCPs will be able to review diet/nutrients for group 2 and 3 patients and can support dietary change or nutritional goals, as part of patients' ongoing clinical management, during existing scheduled clinic visits (N.B. not all participants will have a scheduled clinic appointment during the study).

2 months after recruitment, all participants will receive a link to an online feedback questionnaire.

At end of study, HPCs will be invited to provide feedback during a 30 minute interview.

See published results at https://www.mdpi.com/2072-6643/14/9/1768

Eligibility Criteria:
Inclusion Criteria:

* Able to use a smartphone or tablet
* Have regular access to the internet
* Aged 18 years or over
* Not receiving palliative treatment for their condition
* No pre-existing condition, eg. diabetes which requires a specific diet or eating disorder
* No food allergies
* Be receiving ongoing gastrointestinal surgery or weight management treatment
* Be able to read and understand English

Exclusion Criteria:

-
Evaluation the Post Operative Pain of Endodontic Treated Molar Tooth With Race and Reciprocal Systems Among Bandarabbas Patients in 2017

extrusion of infected dentin into the periapical tissue has been suggested as a major source of pain after endodontic treatment. Although debris extrusion is an inevitable finding even when instrumentation is limited to the confines of the canal, different armamentarium seem to be associated with different amounts of debris extrusion. Studies on the effect of various rotary files on post-endodontic pain are very few and have yielded conflicting results with some favoring full-sequence and others leaning towards reciprocal rotary systems. This study aims at assessing the intensity of post-endodontic pain following two different rotary systems, Reciproc and race.

Methods: in this single-blind, parallel-grouped randomized clinical trial a total of 150 otherwise healthy patients aged between 20 to 50 years old with a pulpal status of irreversible pulpitis for one tooth in the upper or lower molar region were analyzed. A clinician performed the endodontic treatment in two groups, a group instrumented using race and a third group with instrumentation performed using Reciproc rotary systems.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria: the otherwise healthy patients were aged between 20 to 50 years old with a pulpal status of irreversible pulpitis for one tooth in the upper or lower molar region.

Exclusion Criteria:

* Exclusion criteria: previous endodontic treatment; a history of drug intake including corticosteroids; opioids and NSAIDs in the previous 12 hours; pregnancy; complicated anatomy (curves greater than 25 degrees); calcifications; internal \& external resorption; open apices; periodontal disease; swelling \& abscess; presence of periapical lesions; sensitivity to percussion and lack of occlusal contact.
Markers of Infection and Resistance in Invasive Fusariosis

In recent decades, invasive fusarioses have been emerging fungal pathologies with high mortality. The prognosis depends on the speed of the diagnosis, but currently biological diagnosis is mainly based on fungal culture, no specific biomarker for this microorganism is available in current clinical practice. The genus Fusarium also shows reduced sensitivity to antifungals commonly used and recommended in clinical practice, such as voriconazole or amphotericin B.

The main objective of this study is to describe the proportions of different fungal species in positive fungal cultures in patients with invasive fungal infection (IFI) or fungal keratitis. The secondary objectives are the description of the dosage of galactomannans, beta (1,3) -D-glucans and the rate of detection of DNA circulating in case / control groups for the 2 clinical forms studied. In patients with evidence of Fusarium wilt, the study will describe the distribution of the different minimum inhibitory concentrations (MIC) depending on whether or not different antifungals are taken, the vital status at 3 months, and the response or not to treatment. Finally, the presence of genetic markers will be described according to the groups of MIC values.


Eligibility Criteria:
Inclusion Criteria:

* Suspicion of invasive fungal infection involving the performance of a blood culture or a skin biopsy or diagnosis of keratitis involving the taking of a cornea sample
* Fungal culture carried out on this sample
* Person having been informed of the research and not having opposed the use of their data

Exclusion Criteria:

* Clinical diagnosis of superficial fusarium wilt (onychomycosis, etc.)
The Effects of Rasagiline on Cognitive Deficits Associated With Parkinson's Disease

The objective of the study is to assess the effects of rasagiline on cognitive functions in patient with Parkinson's disease. Patients on any dopaminergic medications will be assigned to receive rasagiline 1 mg or placebo over 3 months. Cognitive functions will be assessed by selected neuropsychological tests representing each cognitive domain.

The primary objective of this study is to assess the effects of rasagiline on cognitive deficits in non-demented patients with PD. The secondary objective is to assess affective changes in this patient population. This will be a randomized, double-blind, placebo controlled study in 1-3 centers. Patients will be recruited from the Movement Disorders Outpatients Clinic, Department of Neurology, Istanbul Faculty of Medicine, Dokuz Eylul University and Marmara University. Eligible patients will be randomly assigned to rasagiline 1 mg or placebo. Patients will be treated with the study medication over 3 months. Cognitive and behavioral assessments will be performed at baseline, at 4 weeks and at the end of the study, at 12 weeks. A total of 40 PD patients with cognitive deficits, but without dementia will be recruited. No sample size calculation will be performed, a sample of convenience will be used.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients of any age
2. Diagnosis of Idiopathic PD according to the UK Brain Bank Criteria for the clinical diagnosis of PD.
3. Patients with cognitive impairment associated with PD, defined as:

   1. Subjective complaints of impaired cognitive functions such as forgetfulness, word finding difficulties or inattentiveness
   2. Presence of objectively demonstrable cognitive deficits in at least 2 out of the 4 cognitive domains typically impaired in PD. These include attention, executive functions, memory and visuo-spatial functions. The performance in the following test scores must be 1.5 standard deviations below the mean normative score for age and education of the patient: Digit Span for attention, Letter Fluency test for executive function, Logical Memory Sub-scale from the Wechsler Memory Scale-Revised and Line Orientation Test for visuo-spatial function.
4. Patients with a Hoehn and Yahr stage I-III when "on"
5. Literate patients who are able to follow test instructions

Exclusion Criteria:

1. Diagnosis of dementia due to PD according to DSM IV criteria
2. Diagnosis of current major depressive episode according to DSM IV criteria
3. Presence of any other neurodegenerative disorder other than PD
4. Presence of any unstable or untreated systemic disorder such as diabetes, cardiac failure, renal failure
5. Use of any prohibited concomitant medication
Adjusted Ventilatory Assist (NAVA-NIV) in Infants: Short-term Physiological Study

Neurally Adjusted Ventilatory Assist (NAVA) is a new form of partial support wherein the machine applies positive pressure throughout inspiration in proportion to the electrical activity of the diaphragm (EAdi), as assessed by trans-esophageal electromyography. To test the hypothesis that NAVA could provide better patient-ventilator synchrony during NIV delivered by nasal-facial mask as compared to conventional flow-triggered PSV in infants with Acute Respiratory Failure.

Neurally Adjusted Ventilatory Assist (NAVA) is a new form of partial support wherein the machine applies positive pressure throughout inspiration in proportion to the Electrical Activity of the diaphragm (EAdi), as assessed by trans-esophageal electromyography. Because ventilator functioning and cycling are under control of the patient's respiratory drive and rhythm, NAVA has the potential to enhance patient-ventilator interaction ensuring synchrony and minimizing the risk of over-assistance. A high incidence of asynchrony events has been demonstrated to have a significant clinical impact by favouring weaning failure and longer duration of mechanical ventilation.

NAVA has been implemented safely in animals, in healthy volunteers and in critically ill adults and has been shown to improve patient-ventilator synchrony, to limit excessive airway pressure and tidal volume, and to unload the respiratory muscles in tracheally intubated patients.

Moreover NAVA was found to be effective in delivering non-invasive ventilation (NIV) even when the interface was excessively leaky (75% leak) with reduced positive end-expiratory pressure. With these conditions, NAVA was able to unload the respiratory muscles and preserve gas exchange, while maintaining synchrony to respiratory demand. To date, no data exist on the use of NAVA in infants during noninvasive ventilation. The aim of this physiological study is to compare patient-ventilator interaction in infants receiving NIV by NAVA and Pressure Support Ventilation (PSV).

Eligibility Criteria:
Inclusion Criteria:

* Infants aging \> 1 month and \< 2 yrs
* ARF (PaO2/FiO2 \< 300 mmHg)
* Accessory muscle recruitment
* Respiratory Rate more than 2 SD related to age
* Intact neuromuscular pathway to the diaphragm

Exclusion Criteria:

* Hemodynamic instability
* Facial Surgery
* Reduction in airway protection
* Coma
* Contraindication to insert the nasogastric catheter
* Heart and lung transplant
* Increase in PIC
* Refusal of the parents or legal guardian
* Enrolment in other research protocols
Supporting the Recovery Needs of Patients Following Intensive Care

Recovery for intensive care survivors is limited by ongoing problems with walking, strength, fatigue, mental distress and cognitive morbidity known as 'Post Intensive Care Syndrome'. There has been increasing interest in ways that clinicians can support patients in their post ICU recovery.

The investigators are undertaking a co design approach to informing the design of a recovery pathway for patients who have been admitted to the intensive care to support them in their return to home, family and working responsibilities.

This project will aim to involve \~ 20 past ICU patient/family members and \~20 health professionals to participate in a co-design approach to examine the recovery needs and resources that are required to support patients after leaving hospital. Using an experience based co design methodology three 2-hour workshops will be run with the first workshop involving patients/family members, the second involving healthcare professionals to separately gain thoughts and perspectives, and then the final workshop which will be combined to identify and problem solve priority resources and solutions.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized adults, aged 18 years or over
* Admitted to the ICU requiring invasive mechanical ventilation for \> 48 hours and remain in the ICU for a minimum of four days
* Living at home before the current admission (not in a facility and/or no fixed abode)

Exclusion Criteria:

* Non-English speaking (insufficient English language skills to read and understand questionnaires and patient information consent form)
* Pre-existing documented cognitive impairment
* Spinal cord injury or other primary neuromuscular disease
* New lower limb fracture with altered weight bearing status
* Expected survival \< 3 months according to the treating medical team
* Active substance abuse or psychosis
* Lack of access to telephone / computer or inability to use these resources independently (which would impact on ability to complete the intervention)
* Pregnancy
* Suicidality
* Incarcerated
* Cardiac surgery within this ICU admission (as these patients routinely receive a standard outpatient rehabilitation through cardiac rehabilitation)
* Poor premorbid mobility defined as \< 10 metres ambulation +/- gait aid independently
Invasive Hemodynamic Response to Transcatheter Edge-to-Edge Mitral Valve Repair

Studying the effects of Trans-catheter Mitral Valve Repair (TMVr) on the hemodynamics and biomarkers in patients with severe mitral valve regurgitation.


Eligibility Criteria:
Inclusion Criteria:

* Adults (age ≥ 18 years) with severe, symptomatic primary mitral regurgitation identified by Doppler transthoracic echocardiogram
* Heart team (cardiologist and cardiac surgeon) agree that patient would be eligible for TMVR with Transcatheter edge to edge repair device.
* TMVR procedure will be performed in the cardiac catheterization laboratory for hemodynamic data recording

Exclusion Criteria:

* Women who are pregnant or believe they could be pregnant
Simultaneously PET/MRI in Prolonged DOC Patients

Recently introduced hybrid PET/MR scanners provide the opportunity to measure simultaneously, and in direct spatial correspondence, both metabolic demand and functional activity of the brain, hence capturing complementary information on the brain's physiological state. Here we exploited PET/MR simultaneous imaging to explore the relationship between the metabolic information provided by resting-state fluorodeoxyglucose-PET (FDG-PET) and fMRI (rs-fMRI) in patients with disorders of consciousness.


Eligibility Criteria:
Inclusion Criteria:

* DOC patients （acute, subacute or chronic period）: Coma, UWS and MCS.

Exclusion Criteria:

* neuromuscular blocking agents or sedative drugs administered within the prior 24 hours；
* unstable medical condition；
* mental implant in the brain
Side-to-side Duodenojejunostomy After Distal Duodenal Resection (DUORESECT)

Lower partial duodenectomy could be indicated in case of injury, wide neck diverticulum, tumor invasion by other tumors such as retroperitoneal sarcoma and primary tumor of 3rd and 4th portion of the duodenum. Reconstruction after resection is usually performed by a end-to-end or end-to-side anastomosis.

The investigators analyze the short and long-term results of a case series with resection for various lesions in the third and fourth duodenal portions and reconstruction of the intestinal transit through side-to-side duodenojejunostomy

The investigators retrospectively looked at patients who, from January 2010 to December 2018, underwent surgical procedures for duodenal tumors or other type of primary lesions.

Patients with primary duodenal lesions who underwent surgery were included in the study. Patients with secondary duodenal infiltration or liver and/or peritoneal metastasis found during intraoperative exploration were excluded. Similarly, if the surgeons appreciate the involvement of the pancreas during the procedure, for which they would have to perform a pancreaticoduodenectomy, the patient would be excluded.

Diagnostic management included establishment of a medical history, performance of clinical examination and imaging tests, including endoscopic exploration and, when neoplasm was suspected, computerized tomography (CT) scan, to confirm the tumor origin and growth, as well as infiltration, if any, of adjacent structures. These also allowed to rule out distant metastases, and to assess resectability and the option for reconstruction according to the location.

The variables taken into account were age, sex, the American Society of Anesthesiologists (ASA) classification, preoperative examinations performed and type of lesion susppected as benign, duodenal adenocarcinoma or gastrointestinal stromal tumor (GIST). Perioperative clinical results, surgical approach, type of resection and reconstruction, and intraoperative complications were recorded. Details of the postoperative course were collected. Some of the key short-term data recorded included length of hospital stay, complications' ranking (according to the Clavien-Dindo score; 'severe complication' is defined as greater or equal to IIIa), re-operation, re-admission and operative mortality (\< 90 days after operation). Some of the key long-term data recorded were, digestive symptoms along follow-up, specific disease-free survival (DFS) and overall survival (OS)

Eligibility Criteria:
Inclusion Criteria:

* Patients with primary duodenal lesions who underwent surgery

Exclusion Criteria:

* Secondary duodenal infiltration or liver and/or peritoneal metastasis found during intraoperative exploration
Evaluation of Long-term Immunogenicity and Safety of a Human Papillomavirus (HPV) Vaccine in Healthy Female Subjects

Infection with human papillomavirus (HPV) has been clearly established as the necessary cause of cervical cancer. This study is designed to evaluate the long-term immunogenicity and safety of the GSK Biologicals' 580299 HPV vaccine up to 10 years after administration of the first dose of HPV vaccine (Month 0) in primary study NCT00196937. This protocol posting deals with objectives \& outcome measures of the extension phase from Year 5 to Year 10. The objectives \& outcome measures of the primary phase and extension phase up to year 4 are presented in a separate protocol posting (NCT00196937).

Subjects were aged 15-55 years at the time of entry into the primary study (NCT00196937). No vaccine was administered in this extension study.

Results on outcome measures describing analyses on other studies are not reported in this record. Please refer to the records mentioned in the respective outcome measure titles.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believed that they could and would comply with the requirements of the protocol.
* A female who had been enrolled in NCT00196937 study and received three doses of HPV-16/18 vaccine.
* Written informed consent obtained from the subject.

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) or planned use during the study period.
* Chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs occurring less than three months prior to blood sampling.
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
* Administration of immunoglobulins and/or any blood products within the three months preceding blood sampling.
* Administration or planned administration of any HPV vaccine, other than the three doses of HPV-16/18 vaccine administered in NCT00196937 study.
Use of Buventol Easyhaler and Bufomix Easyhaler in Methacoline Challenge Testing

The study compares Buventol® Easyhaler® and Bufomix® Easyhaler® to the current standard treatment during methacholine challenge test. The trial will also provide inspiratory flow profile data for Easyhaler inhaler.

This trial is designed to provide a further evidence for the use of Easyhaler in diagnostic bronchial challenge tests and on the use of Easyhaler inhaler during obstructive event.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent (IC) obtained.
2. Finnish speaking adult (≥ 18 years old) subject indicated for methacholine challenge test.
3. The subject experiences FEV1 drop ≥ 20% compared to post-diluent spirometry.

Exclusion Criteria:

1. Subjects not eligible for methacholine challenge test for example for any of the following reasons:

   * Any respiratory infection within 2 weeks, or severe respiratory infection within 4 weeks before the study visit
   * FEV1 \< 60% of predicted or \< 1.0 l
   * Inability to perform acceptable and repeatable spirometry manoeuvres throughout the test procedure
   * Uncontrolled hypertension
   * Acute chest pain or unstable angina pectoris
   * Significant cardiac arrhythmias
   * Pneumothorax or recent bronchoscopy
   * Myocardial infarction or stroke in last 3 months
   * Known aortic aneurysm
   * Recent eye surgery or intracranial pressure elevation risk
   * Cholinesterase inhibitor medication
   * Pregnant or lactating females
2. Subjects who have used the following treatments before the study visit:

   * Short-acting β-agonists within 12 h
   * Long-acting β-agonists within 36 h
   * Ultra-long-acting β-agonists within 48 h
   * Long-acting anti-muscarinic agents within 168 h
   * Short-acting anticholinergics within 12 h
   * Oral theophylline within 24 h
   * Inhaled corticosteroids, leukotriene receptor antagonists and chromones within 4 weeks
3. Known hypersensitivity to the active substance(s) or the excipients of the study treatments (for example severe milk allergy, lactose contains small amounts of milk protein).
4. Administration of another investigational medicinal product within 30 days before the study visit.
Phase Three Clinical Trials of Trivalent Rotavirus Genetic Reassortment Vaccine

Assessment and evaluation the rotavirus gastroenteritis prevention effect and severe rotavirus diarrhea reducing effectiveness of human body, which inoculate trivalent rotavirus genetic reassortment vaccine.


Eligibility Criteria:
Inclusion Criteria:

* 6 to 13 weeks aged healthy baby;
* Guardian volunteer to participate in the study and sign informed consent;
* have use thermometer as required and the ability to fill in the diary table;
* Subjects guardian can abide by the requirements of clinical research scheme;
* The past has not been vaccinated rotavirus vaccine;
* Normal term eutocia, birth weight up to standard;
* Axillary temperature is 37.0 ℃ or less.

Exclusion Criteria:

* With allergy, convulsion, epilepsy, encephalopathy and spirit history or the family history;
* Be allergy to any ingredients in the vaccine;
* Known immunology function damage or low person;
* Immunosuppressant therapy Accepter;
* Suffering from congenital malformation and developmental disorder;
* Known or suspected also suffer from diseases including: digestive system disease, respiratory system disease, acute infection, mother or I have HIV infection, cardiovascular diseases, malignant tumor during treatment, skin disease;
* Inoculation other vaccine within 7 days.