cyrilzakka/clinical-trials huggingface dataset:
Role of Pre-operative CPET in Pancreatoduodenectomy

A clinical database has been prospectively maintained by the investigators, with details of pancreatic resections since January 2016. It includes pre-operative details, details of multidisciplinary team (MDT) meeting, details of pre-operative biliary stenting, intra-operative details, post-operative morbidity and mortality, details of histopathological diagnosis, recurrence and survival. Data was collected onto the database (excel sheet) from trust data software, clinic letters, Somerset Cancer registry and clinical portal.

Retrospective analysis of prospectively maintained database. A clinical database has been prospectively maintained by the investigators, with details of pancreatic resections since January 2016. It includes pre-operative details, details of multidisciplinary team (MDT) meeting, details of pre-operative biliary stenting, intra-operative details, post-operative morbidity and mortality, details of histopathological diagnosis, recurrence and survival. Data was collected onto the database (excel sheet) from trust data software, clinic letters, Somerset Cancer registry and clinical portal.

Specific CPET data to be collected:

1. Exercise induced ST ischaemia- yes/no
2. VO2 peak: actual and predicted
3. Anaerobic threshold
4. VE/VCO2
5. Pulmonary function test- normal/ obstructive/ restrictive
6. Duration of pedalling bike
7. 30 day predicted risk
8. Completed the test - yes/no
9. Reason for incomplete test The CPET specific data will be collated from clinic letters, MDT meeting outcomes and CPET reports stored in hospital drive (access limited to anaesthetists only presently).

Data analysis will be done using IBM SPSS version 25. Investigators plan to use parametric and non-parametric tests and binary logistic regression analyses to compare predicted to actual mortality and morbidity, between the patients who have had CPET and those who have not.

6 STUDY SETTING: This is a single centre study, to be done at, Royal Blackburn Hospital, East Lancashire Hospitals NHS trust, a District general Hospital in North of England. The study will be carried out in the department of General and HPB surgery, in liaise with Department of anaesthesia. This is the HPB referral centre for Lancashire and South Cumbria and incorporates patients referred for pancreatic surgery from three hospital trusts (Lancashire Teaching, University Hospital Morecambe Bay and Blackpool Teaching Hospitals). The data will be stored in the trust computer system, using a password protected excel sheet. The investigators responsible for the study only, will be provided with access to the database.

Eligibility Criteria:
Inclusion Criteria:

* All pancreatic resections during the study period, performed for:

  * Cholangiocarcinoma
  * Duodenal and periampullary tumors
  * Pancreatic tumors
* All the patients in the database who have undergone Whipple (pancreatoduodenectomy)

Exclusion Criteria:

* Duodenal or gastric resections, not in conjunction with pancreatic resections
* Distal pancreatectomy
* Partial excision
* Enucleation of lesions
* Open and close when inoperable
Acute High-risk Abdominal Surgery Study - an Optimized Perioperative Course

The objective of this study is to implement an optimized perioperative course for patients undergoing acute high-risk abdominal surgery in order to improve the outcome.

The optimized perioperative course consists of a number of interventions carried out before, during and after surgery.

Emergency surgery is associated with high mortality rates, post-operative complications and prolonged duration of hospital admission. The investigators will implement a multidisciplinary optimized perioperative course consisting of a number of interventions carried out before, during and after surgery.

Hypothesis: An optimized perioperative course will reduce the 30-day mortality in emergency abdominal surgery patients.

The investigators will do a post-hoc analysis of the data registered.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing primary emergency laparotomy or laparoscopy
* patients undergoing reoperation after abdominal surgery.
* Age \> 18 years

Exclusion Criteria:

* Appendectomy
* Emergency laparoscopic cholecystectomy
* Emergency diagnostic laparoscopy without intervention
Real-world Effectiveness of Combination Therapies in Primary Care Asthma Management

To evaluate whether beclomethasone dipropionate / formoterol (BDP/FOR; Fostair® 100/6) is at least equivalent in terms of exacerbation prevention to fluticasone dipropionate / salmeterol (FP/SAL; Seretide® 125) in matched asthma patients switching to BDP/FOR following treatment with FP/SAL in normal clinical practice compared with patients not switched.

To evaluate whether beclomethasone dipropionate / formoterol (BDP/FOR; Fostair® 100/6) is at least equivalent in terms of exacerbation prevention to fluticasone dipropionate / salmeterol (FP/SAL; Seretide®) in matched asthma patients switching to BDP/FOR following treatment with FP/SAL in normal clinical practice compared with patients not switched. To evaluate respiratory outcomes for Fostair in comparison to Seretide using a UK primary care database (in patients switched for cost rather than clinical reasons).

Eligibility Criteria:
Inclusion Criteria:

* Aged: 18-80 years 61-80 years to be non-smokers only
* Evidence of asthma: a diagnostic code for asthma or two scripts for asthma..
* Baseline FP/SAL therapy: ≥2 prescription for ICS/LABA therapy as FP/SAL
* Evidence of Continuing Therapy: Include only patients who receive ≥2 prescriptions for the therapy under study during the outcome year (i.e. ≥1 prescription at the index date and ≥1 other). UK average is 3-4 prescriptions refilled per year, so ≥2 ensures capture of "real-life" data.
* Evidence of Switching for economic reasons: FP/SAL patients from practices with ≥5 switches to Fostair in a 3 month period to minimise data taken from switching of anomalous patients; optimal practices for inclusion are those switching "wholesale" for economic reasons.

Exclusion Criteria:

* Any chronic respiratory disease other than asthma
* Are receiving maintenance oral steroid therapy during baseline period
Non-invasive Transcranial Electrical Stimulation in MS

The goal is to investigate the effects of non-invasive transcranial electrical stimulation on cognition in MS.

The participants' baseline cognitive function will be assessed with a tablet-based, videogame-like software specifically designed as a medical device to test and train cognitive function for populations with cognitive disorders. After baseline test assessment, participants will receive stimulation while playing the training version of the software. After the stimulation, cognitive performance will be evaluated again with the testing version. Investigators will assess changes in cognitive performance associated with stimulation.

Eligibility Criteria:
Inclusion Criteria:

* age 18-65,
* diagnosis of MS
* Expanded Disability Status Scale (EDSS)≤6.5, no paresis of the upper limbs
* a minimum of 3 months since the last relapse
* Beck Depression Inventory\<19
* normal hearing
* and no changes in MS or symptomatic medications in past 2 months

Exclusion Criteria:

* prior brain surgery
* clips in brain
* epilepsy or other neurological or non-affective psychiatric disorders
* pregnancy
A Two-Part Study to Assess the Safety, Tolerability, PK and PD of ONO-7684 in Healthy Adult Volunteers

This is a first in human study to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of ONO-7684 in healthy adult volunteers. This study will be conducted in 2 parts: Part A is a single-ascending dose and Part B is a multiple-ascending dose.

This study aims to obtain safety, tolerability, pharmacokinetic and pharmacodynamic data when ONO-7684 is administered orally as single doses and as multiple doses to healthy subjects. The study will consist of 2 parts: A single ascending dose (SAD) phase (Part A); a multiple ascending dose (MAD) phase (Part B). One cohort of Part A will receive ONO-7684 under both fasted and fed conditions to investigate the effect of food.

Eligibility Criteria:
Inclusion Criteria:

1. 18-55 years
2. normotensive male volunteers, or female volunteers of non-childbearing potential (Part B only)
3. body mass index 18.0-30.0 kg/m2
4. deemed healthy on the basis of a clinical history, physical examination, ECG, vital signs, and laboratory tests of blood and urine
5. registered with a General Practitioner (GP) in the UK
6. agree to use an effective method of contraception
7. able to give fully informed written consent

Exclusion Criteria:

1. Positive tests for hepatitis B \& C, HIV
2. severe adverse reaction to any drug
3. sensitivity to trial medication
4. drug or alcohol abuse
5. current smoker or use of nicotine containing products in the previous 6 months
6. vegetarians or vegans, or unwilling to eat a high-fat breakfast (Part A food effect cohorts only)
7. use of strong CYP3A4/5 or P-glycoprotein inhibitors or inducers, anticoagulants, antiplatelet agents, non-steroidal anti-inflammatory drugs and/or acetylsalicylic acid within the previous 30 days
8. prescription or over-the-counter medication, vitamins, herbal treatments or dietary supplements within the previous 7 days (with the exception of paracetamol \[acetaminophen\])
9. participation in other clinical trials of unlicensed medicines, or loss of more than 400 mL blood, within the previous 3 months or plan to donate blood or blood products in the 3 months after the trial
10. vital signs outside the acceptable range
11. clinically relevant abnormal findings at the screening assessment (including creatinine clearance, haemoglobin levels and QTcF)
12. acute or chronic illness
13. clinically relevant abnormal medical history or concurrent medical condition
14. objection by GP
15. possibility that volunteer will not cooperate
16. pre-menopausal females who are pregnant or lactating, or who are of childbearing potential
Early Versus Delayed Oral Liquids and Soft Food After Elective Ceasarean Section

To compare the safety of early versus delayed oral feeding after uncomplicated cesarean section under spinal anesthesia

Cesarean section is one of most common surgical procedures saving both for mother and newborn when medically indicated .traditionally patients are not given fluids or food afer abdominal surgery until bowel function return as evidenced by bowel sounds passage of flatus or stool or feeling of hunger the rationale of this practice is to prevent postoperative nausea , vomiting, distension and other complications

Eligibility Criteria:
Inclusion Criteria:

* previous 1,2,3 cs Uncomplicated elective cs Singletone pregnancy Spinal anesthesia

Exclusion Criteria:

* women with medical disorder HTN, DM History of bowel surgery or intraoprative complication Contraindication to spinal anesthesia
Prognostic Factors of COVID19

COVID-19 is an emerging disease, for which no specific treatment options are currently available. Since the end of February 2020, and due to a SARS-CoV-2 superspreading event (religious meeting), the Strasbourg University Hospital (HUS) had faced a sudden increase of the number of COVID-19-positive patients in serious condition requiring hospitalization. At the same time, many people develop only mild or moderate symptoms. To date, the prognostic factors for the course of SARS-CoV-2 infection are unknown. The primary purpose of the "COVID-HUS" protocol is to investigate viral and host-related factors to understand the pathophysiology of COVID infection and to open the way for new diagnostic, prognostic and therapeutic strategies against SARS CoV-2 .

The secondary objectives are

* Monitoring of viral replication of SARS-CoV-2 in the blood and respiratory tract in infected patients
* Monitoring of the humoral and cellular response directed against SARS-CoV-2
* Identification of factors leading to significant and / or prolonged viral replication of SARS-CoV-2 in the blood or respiratory samples
* Evaluation of the benefit of possible treatments implemented following the diagnosis of SARS-CoV-2 infection
* Exploration of the B and T immune repertoire sequences targeting SARS-CoV-2 in infected patients
* Typing of the HLA system in infected patients


Eligibility Criteria:
Inclusion Criteria:

* Adult and pediatric with suspicion or a confirmed SARS-CoV-2 infection
* Patient who has signed a non-opposition form (or a form signed by a family member or a support person if the seriousness of the patient's condition and the emergency situation do not allow it) or who has given his oral agreement to the doctor

Exclusion Criteria:

* Patient's explicit refusal to participate
* Subject deprived of liberty or subject to the protection of justice
* Subject under guardianship or trusteeship
Ertapenem Study in Pediatric Patients Who Have Urinary Tract Infections, Skin Infections or Community-acquired Pneumonia (0826-036)

This study will investigate the safety and efficacy of ertapenem versus ceftriaxone in pediatric patients with urinary tract infections, skin infections, or community-acquired pneumonia.


Eligibility Criteria:
Inclusion Criteria:

* Patients with UTI must have white blood cells and bacteria in the urine with bladder catheterization or urologic abnormality, kidney infection or both
* Patients with SSTI must have a recent infection
* Patients with CAP must have a chest x-ray indicating bacterial pneumonia and a fever

Exclusion Criteria:

* Patients with complete urinary tract blockage or kidney abscess
* Patients with infected burn wounds, bone infection, or bacterial arthritis
* Patients on mechanical ventilation or those with cystic fibrosis, chronic lung disease or puss in the space between the chest wall and lung
Role of Armeo-Power and Muscle Vibration in Upper Limb Rehabilitation

Muscle vibration (MV) has been suggested as a useful non-pharmacological approach to control spasticity. Armeo Power® (AP) is a robotic exoskeleton for rehabilitation allowing early rehabilitation treatment. The objective of our study was to determine whether AP training coupled with MV applied on antagonist muscles of the spastic upper limb (UL) can reduce the spasticity of agonist muscles. We enrolled 20 chronic post-stroke patients, who underwent 40 daily sessions of AP training. Ten subjects (group-A) received muscle MV (on triceps brachii, deltoid, and supraspinatus), whereas the other 10 (group-B) underwent a sham vibration.


Eligibility Criteria:
Inclusion Criteria:

* a first ever supra-tentorial unilateral (left hemisphere) ischemic stroke experienced more than three months before the enrollment;
* a deficit of shoulder abductor, arm flexor, and elbow extensor muscles ranging from 2 to 4 on the Medical Research Council scale (MRC);
* a spasticity of biceps brachii (BB), pectoralis major (PM), and latissimus dorsi (LD) (namely, spastic agonist muscles) ranging from 1+ to 3 on the Modified Ashworth Scale (MAS);
* age between 50 and 80 years; and (v) Caucasian ethnicity.

Exclusion Criteria:

* history of concomitant neurodegenerative diseases or brain surgery;
* severe cognitive (Mini-Mental State Examination score \<23 points) or language impairment (Boston Disability Aphasia Quotient \<4/5);
* severe neglect (Catherine Bergego Scale \>15/30);
* systemic, bone, or joint disorders, tumors, changes in either central or peripheral sensitivity as well as visual impairments able to interfere with the aims and methods of the research;.(v) concomitant use of drugs for spasticity;
* botulin toxin treatment in the last eight months;.(vii) TMS contraindications;
* history of psychosis;
* limited passive range of motion (shoulder abduction \<60°, elbow extension \<30°, specified by a goniometric assessment).
Lamictal TM, Haloperidol Decanoate in Schizophrenia

The purpose of this study is to determine the effect of lamotrigine augmentation of Haloperidol decanoate in the treatment of Resistant Schizophrenia predominantly by verbal resistant hallucinosis: A randomized, double-blind, placebo-controlled, study.

Nadir A.Aliyev \& Zafar N.Aliyev

Central Mental Clinic for Outpatients of Baku city of Azerbaijan Republic

Abstract:

OBJECTIVE: The current paper reports on a double-blind, randomized study of the role of lamotrigine as an augmentation agent to haloperidol decanoate in the treatment of out patient's schizophrenia with verbal resistant hallucinosis.

METHOD:A structured clinical interview, for DSM-IV Axis I Disorder, Patient Edition, was used to diagnose schizophrenia according to DSM-IV. Three hundred fifty patients were studied. The patients were then randomly divided into two groups on 175 subjects in each group. First group patients received either haloperidol deaconate 50 mg in weekly intramuscular and lamotrigine 150-200 mg in day per so for 12 weeks. Second group patients were given haloperidol deaconate 50 mg in weekly intramuscular and placebo per os for 12 weeks. Data for clinical assessments were collected at weeks 0, 6 and 12 weeks. The expressiveness of psychopathology was estimated on PANSS. Test response in both groups was defined as a reduction in the PANSS by using analysis of variance and chi-square tests.

Eligibility Criteria:
Exclusion Criteria:

* Display an acute systemic medical disorder or a medical disorder requiring frequent changes in medication;
* Display a history of seizures, cerebrovascular disease, structural brain damage, from trauma, focal neurological sings on examination, or evidence of any progressive neurological disorder, substance dependence (except tobacco).

Inclusion Criteria:

* age from 18-60;
* both gender;
* resistant scizophrenia patients;
* previous treatment history;
* verbal resistant hallucinosis.
Evaluation of the IFuse Bedrock Technique in Association with Posterior Lumbosacral Fusion with Iliac Fixation.

The purpose of this study is to describe the impact of the iFuse Bedrock technique to decrease post-operative pains in patients who underwent multilevel posterior lumbosacral fusion.

This study is a multicentric, post-marked clinical investigation to assess the efficacy of the iFuse Bedrock technique to avoid post-operative pains in patients who underwent open posterior multilevel lumbosacral fusion. Subjects will be monitored for lumbar pains (Oswestry score, VAS, SF-12 questionnaire) and sacroiliac joint pains (provocative tests) up to 12 months after initial procedure. A single CT-scan acquisition will be performed at 12 months to detect any iFuse system-related abnormality (implants loosening or breakages).

Eligibility Criteria:
Inclusion Criteria:

* Subject scheduled for open posterior lumbosacral arthrodesis (including at least the following three vertebrae: L4, L5 and S1) associated with a sacroiliac fusion procedure and iliac fixation (thoracolumbar fusion procedures extended to sacrum are eligible in the study);
* Insertion of at least 1 iFuse-3D implant according to the iFuse Bedrock technique (uni- and bilateral insertion are eligible);
* Subject who preoperatively responded positively to pain provocation tests for SIJ dysfunction with or without a positive SIJ infiltration test;
* Patient with a degenerative sacroiliac joint disease requested a fusion procedure;

Exclusion Criteria:

* Major osteoporosis (DEXA scan \> 3);
* Any previous history of sacroiliac joint fusion or any surgical procedure involving a S2-iliac fusion;
* Subjects requested a SIJ fusion without the iFuse-3D device or iFuse-3D not inserted according to the manufacturer instruction (Bedrock technique);
* Subjects with a medical or surgical contraindication preventing the intervention from being performed or potentially interfering in the interpretation of the data collected (neurologic condition, local or systemic infection, any known allergy to surgical implants, psychiatric diseases, ...);
* Currently pregnant or planning pregnancy;
* Prisoner or a ward of the state;
* Subject no willing to participate in the study;
* Subject not affiliated to a social security insurance.
High Resolution Optical Imaging of the Esophagus Using the NvisionVLE™ Imaging System

This is a single center, single arm, open label observational trial of patients undergoing EGD. The primary objective of this clinical trial is to evaluate the ability of physicians to position the NvisionVLE Optical Probe to acquire an image of an area of the esophagus to identify and discriminate abnormal areas of tissue from normal.


Eligibility Criteria:
Inclusion Criteria:

* Males and females over the age of 18 years.
* Patients presenting for an EGD.
* Ability to provide written, informed consent.
* Females who are able to become pregnant, are willing to take a pregnancy test.

Exclusion Criteria:

* Patients on anticoagulation undergoing high risk procedures in accordance to ASGE guideline for the management of antithrombotic agents for endoscopic procedures (2009)\*.
* Patients with esophageal varices that preclude biopsies.
* Presence of an esophageal mass that precludes full distention of the balloon from the NvisionVLE catheter.
* Patients with esophageal strictures that would prevent adequate expansion of the balloon from the NvisionVLE catheter.
* Patients with known inflammatory disease, esophageal tears or ulcers, which prohibit full distention of the balloon from the NvisionVLE catheter.
* Patients with known eosinophilic esophagitis.
* Patients that are pregnant.
* Patients with a history of hemostasis disorders\*\*.

  * Patients on anticoagulation undergoing low risk procedures are not excluded. \*\* Hemostasis disorders will include, but will not be limited to: patients with hemophilia or other congenitally acquired clotting factor deficiencies, patients with cirrhosis with coagulopathy, patients known to have thrombocytopenia (\<100,000 plt/ul) and individuals with von Willibrand's disease or other known platelet malfunction disorders.
Clinical Concordance Evaluation of T-SPOT®.TB Assay Performance (T-Cell SelectTM Study)

The objective is to achieve 90% overall, positive and negative clinical concordance between results of the T-SPOT.TB assay, using cells isolated via density gradient centrifugation and positive selection using the T-Cell Select kit, between 0-55 hours following venepuncture

In this study, clinical concordance between results of the T-SPOT.TB assay, using cells stored for 0-8 hours post venepuncture and isolated via density gradient separation and positive selection with magnetic bead isolation using the T-Cell SelectTM Kit will be assessed. Concordance between results of the T-SPOT.TB assay at 0-8 hours post venepuncture and using cells isolated with density gradient centrifugation and results obtained from cells isolated using the T-Cell Select Kit, following storage between 0-55 hours post venepuncture, will be assessed.

Eligibility Criteria:
Subjects presenting at sites enrolling "suspected of having TB infection" population Inclusion Criteria

* Be able to provide informed consent
* Be able to provide a minimum of 7 mL and maximum of 20 mL of whole blood.
* Have suspected TB infection.
* Be at least 18 years of age.
* Live in a high endemic area for TB infection

Exclusion Criteria

• Unable to meet inclusion criteria

Subjects presenting at sites enrolling "no (or minimal) TB risk factors" population Inclusion Criteria

* Be able to provide informed consent
* Be able to provide a minimum of 7 mL and maximum of 20 mL of whole blood.
* Have no suspicion TB infection.
* Be at least 18 years of age.
* Live in low endemic area for TB infection
* Have no previous medical record of TB infection

Exclusion Criteria

* Unable to meet inclusion criteria
* Current/previous TB diagnosis

Subjects presenting at sites enrolling "low/intermediate TB risk factors" population Inclusion Criteria

* Be able to provide a minimum of 7 mL and maximum of 20 mL of whole blood.
* Have no suspicion TB infection.
* Be at least 18 years of age.
* Live in an low/intermediate endemic area for TB infection Exclusion Criteria
* Unable to meet inclusion criteria