cyrilzakka/clinical-trials huggingface dataset:
Validation of a Revised Version of the Danish McGill Ingestive Skills Assessment

The McGill Ingestive Skills Assessment (MISA) for measuring dysphagic clients' functional performance during meals has been previously translated into Danish (MISA-DK) and this translated version validated. Critical issues about the construct validity of the scale, per se, had been raised. Consequently, major revisions of the MISA-DK have been undertaken, which necessitates a new validation process. Therefore, the purpose of this study is to evaluate the construct validity of a revised version of the MISA-DK when used amongst dysphagic adults in hospitals settings and community services.

This study will assess the construct validity of a revised version of MISA-DK in the acute and rehabilitative settings by testing it for fit against a multidimensional Rasch model.

Participants in this research will be 500 dysphagic clients from several centres in Denmark, namely 250 acute patients from three Danish Regional university Hospitals in Herning, Hjørring and Odense, and 250 clients in the rehabilitation setting from the Århus Rehabilitation Institute, Hillerød Rehabilitation Institute and the Rehabilitation division of Copenhagen.

Participants who are judged to have a swallowing problem are assessed with the MISA-DK by special educated occupational therapists The MISA-DK assessment are implemented as a part of the usual assessment routine at the occupational therapy departments at the included centres and will be administered immediately after referral to Occupational therapy. This research will be the first to implement and assess a standardised method for assessing mealtime performance for dysphagia in dysphagic patients across the continuum of diagnosis and rehabilitation recovery.

The application of the Multidimensional Rasch models to the MIS-DK data aims to identify the combination of items in the MISA-DK that provide the highest level of specific objectivity and statistical sufficiency when determining ingestive skill ability. Furthermore, Differential item function by diagnosis, age and setting will be determined.

Eligibility Criteria:
Inclusion Criteria:

* Have a history of swallowing difficulties associated with aging and/or previous or current diagnosis of, but not limited to head and neck cancer (treatment may include surgery, radiation or chemotherapy, or a combination of more than one), stroke, cervical spine abnormality, brain tumor, cardiovascular surgery, Parkinson's disease or multi-morbidity.

  * Fulfils five criteria for direct swallowing evaluation: able to remain alert for at least 15 minutes; able to sit in a chair or bed in at least a 60° upright position, able to swallow saliva, able to cough voluntarily, able to clear the throat twice.
  * Have the capacity to provide informed consent.

Exclusion Criteria:

* The clients are excluded in case of: no dysphagia, known severe cognitive impairment, terminally illness (predicted survival less than 6 months), known contraindications to ingest foods or liquids, poorly controlled psychosis, inability to read consent form; inability or unwillingness to give written informed content.
Oral Carvedilol in Escalating Doses in the Acute Treatment of Atrial Fibrillation

Oral carvedilol administered in escalating doses in patients with atrial fibrillation among patients with AF with fast ventricular rate.

Patients with AF with FVR of any etiology were evaluated and given escalating doses of oral carvedilol in doses - 3.125mg OD, then 3.125 bid, then 6.25mg bid, then 12.5mg bid. The ECG was recorded regularly and analysed for rate reduction or control.

Eligibility Criteria:
Inclusion Criteria:

* AF with fast ventricular rate

Exclusion Criteria:

-
Study to Evaluate the Effect of the Smart Care-diabetes Management System on Subjects With Diabetes

SMARTCARE-diabetes management system' to evaluate the long-term effects on patients with diabetes.

Primary Outcome Measure: To see if there's any change in HbA1C at Visit 6 (12M) compared Visit 2 (baseline) within each group and between the two groups.

All statistical analysis will progress through the SAS (Version 9.1). statistical test's significance level is 0.05. The principle is two-sided test.

Secondary Outcome Measures :

To see if there's any change in HbA1C at each Visit (Visit 3 - Visit 6) compared Visit 2 (baseline) within each group and between the two groups.

Add a Secondary Outcome Measure:

Treatment satisfaction (DTSQ, Diabetes Treatment Satisfaction Questionnaire): To see if there's any change in treatment satisfaction scores compared Visit 2 (baseline) within each group and between the two groups.

Eligibility Criteria:
Inclusion Criteria:

1. Type 2 diabetes
2. At least 1 year after being diagnosed with Type 2 diabetes
3. 7.0% ≤ HbA1c ≤ 10.0%
4. Agreed to participate voluntarily in the study

Exclusion Criteria:

1. Severe chronic disease
2. Diabetes mellitus complications
3. Severe renal disease; Serum creatinin \> 1.5(men), \> 1.4 (women)
4. Severe liver disease or AST, ALT ≥ 2.5 x ULN
5. Known not to be taking medication reliably 3 months before the screening visit
6. Insulin pump user
7. Being registered for other clinical research or are planning to participate in other clinical researches during this study
8. Pregnant woman
9. Illiterate
10. Being assessed irrelevant by the investigator
Anti COVID 19 Hyperimmune Intravenous Immunoglobulin (C-IVIG) Therapy for Severe COVID-19 Patients

Severe ill Patients will be enrolled in the study (n=310) after duly filled consent forms. Recipients will be divided into 2 group, each group contain 155 patients to compare Safety and efficacy of patients in Clinical Trial phase II/III. One Group will receive 0.15g/kg single dose of anti COVID 19 intravenously immunoglobulin (C-IVIG) develop from convalescent plasma of recovered patients from COVID 19, along with Standard of care. The Comparator group will only receive standard of Care

The research team at Dow University of Health Sciences has purified immunoglobulin (both SARS-CoV 2 antibodies and existing antibodies) from convalescent plasma of COVID19 individuals and pooled it to prepare IVIG formulation to treat severe and critically ill COVID-19 patients. Phase I/II trial was completed and showed potential safety and efficacy of the drug Anti COVID-19 intravenous immunoglobulin (C-IVIG) in severe and critical patients with COVID-19.

This trial's aim is to investigate the safety and efficacy of passive immunization in severe COVID-19 patients in phase II/III. The trial will be a randomized, single-blinded, superiority trial, through parallel-group design. The participant will either receive C-IVIG with Standard of care or receive only Standard of care. The study will consist of 310 participants of which 155 will receive a single dose of C-IVIG (0.15g/kg) with the standard of care and 155 will receive only the standard of care. Standard of care is standard hospital care which includes airway support, anti-viral medication, antibiotics, fluid resuscitation, hemodynamic support, steroids, painkillers, and antipyretics.

Randomized test patients will receive a single dose of C-IVIG in the following two dosage groups:

Group 1 (Test): Severe COVID-19 patients: Single dose of 0.15g/Kg with standard hospital care

Group 2 (Comparator): Severe COVID-19 patients: only standard hospital care only

Eligibility Criteria:
Inclusion Criteria:

1. Above 18 years of age
2. Have positive COVID PCR on nasopharyngeal and/or oropharyngeal swabs
3. classified as severe\* COVID-19 according to WHO guideline (5L-15L of oxygen requirement on FM, NRM)
4. Consent given by the patient or first degree relative

Exclusion Criteria:

1. Critical COVID-19 patients \[ non-invasive ventilation (HFNC, BiPAP, CPAP) and invasive ventilation\],
2. Pregnant females
3. Previous allergic reaction to immunoglobulin treatment
4. Known case of any autoimmune disorder
5. Chronic kidney disease
6. Known case of thromboembolic disorder
7. Aseptic meningitis
A Dosing Study of Hyperbaric Oxygen Therapy (HBOT) on Epigenetic Aging

This study aims to assess the impact of hyperbaric oxygen therapy on a number of outcomes, including epigenetic aging, inflammation, and cellular health.

While current research has identified many mechanisms of action, effects and cell signaling benefits resulting from HBOT, we do not have a firm understanding of the timeframe and dosage for many of these expected adaptations. Data from this study will be collected and shared on an ongoing basis throughout the course of care. This research project will help us to confirm these cell-signaling changes and benefits, and also develop a better understanding of the necessary PO2 and time frame required in order to achieve these changes leading to improved patient outcomes in the field of hyperbaric medicine.

Eligibility Criteria:
Inclusion Criteria:

1. Any sex, gender orientation, and ethnicity
2. Between ages 40 and 70
3. Must be willing and able to participate in venipuncture, health history and clinical assessments, lab test assessment, hyperbaric oxygen treatment.
4. Participants must also agree to maintain their current lifestyle choices consistent with pre- participation with this study. Participants should not change their exercise programs, diets, sleep patterns supplements or other. Any significant changes in their lifestyle choices must be reported to the staff.

Exclusion Criteria:

1. Significant change in diagnosis and/or treatment of major illness or injury within 2 years prior to screening, e.g., diabetes, cancer, cardiovascular disease, psychiatric condition
2. Any ongoing immune system concerns or immunodeficiency disease
3. Body mass index (BMI) changes of more than 5% over the course of the study
4. Changes in weight of more than 15 lbs. during the course of the study
5. Presence of a severe active infection as determined by the principal investigator.
6. Any other illness, disorder, alcohol or chemical dependence that in the opinion of investigators would render study participation unsuitable
7. Unable or unwilling to provide required biological sample
8. Unable or unwilling to avoid pregnancy during study period
9. Presence of cataracts before the study begins
10. Myopic changes within the first 30 days of treatment
Carbon-11 Labeled Sarcosine in Prostate Cancer

Men with and without prostate cancer will have a PET/CT scan that measures the level of the amino acid sarcosine. PET is a scanning method that uses short lived radioactivity.

Tissue levels of the amino acid sarcosine are elevated in prostate cancer compared to normal prostate tissues and further increased in metastases from prostate cancer. This research project is designed to test whether 11C-sarcosine (a chemical that is linked to short lived radioactivity) would be useful to detect prostate cancer in men using PET/CT imaging. The uptake and distribution of 11C-sarcosine in men with known or suspected prostate cancer will be determined and compared with results from 11C-choline PET/CT.

Eligibility Criteria:
Inclusion Criteria:

* Males 40 years of age or older
* Confirmed or suspected prostate cancer and will undergo a planned tissue biopsy of the known or suspected tumor (Prostate Cancer Group 1 only)

Exclusion Criteria:

* Active malignancy (except basal cell or squamous cell skin cancer) within the last 2 years
* Body weight \> 350 lbs (158 kg)
* Prisoners
* Subject not willing or able to sign informed consent
Acute Study to Collect Electrical Signals From the Heart Using a Special Lead

The main purpose of this clinical study is to collect electrograms from an investigational lead placed in an extravascular space, for development of a future Implantable Cardioverter Defibrillator (ICD) system.


Eligibility Criteria:
Inclusion Criteria:

* Subject must be undergoing surgical procedure for approved indications for:

  * cardiothoracic surgery where a midline sternotomy is planned, or
  * cardiothoracic surgery where a subxiphoid/paraxiphoid cut for a chest tube is planned, or
  * VT ablation procedure with epicardial access, or
  * implant of a subcutaneous ICD (S-ICD®), or implant of a transvenous ICD (single or dual chamber)
* Subject must be willing to provide Informed Consent
* Subject must be ≥ 18 years old

Exclusion Criteria:

* Subject has known hiatus hernia or moderate or worse pectus excavatum
* Subject had previous pericarditis or prior sternotomy
* Subject has known significant Right Ventricle/ Right Ventricular dilation
* Subject has hypertrophic cardiomyopathy
* Subject is pacemaker dependent
* Subject has known skin irritations due to the Covidien Multi-function defibrillation electrode
* Subject is considered to be at high risk for infection(1)
* Subject has Left Ventricular Ejection Fraction \< 20% (most recent available LVEF measurement in the last 6 months)
* Subject has New York Heart Association Class IV
* Subject has myocardial infarction within the last 6 weeks
* Subject currently has unstable angina
* Subject has severe aortic stenosis
* Subject at high risk of stroke (2)
* Subject has Chronic Obstructive Pulmonary Disease and is oxygen dependent
* Subject has permanent AF and will not be adequately anticoagulated during the ASD2 Acute Testing procedure (3)
* Subject with an implanted active cardiac or non-cardiac device during the ASD2 Acute Testing procedure (e.g., ICD, S-ICD®, Pacemaker, Neuro stimulator)
* Subject is enrolled in a concurrent study that may confound the results of this study, without documented pre-approval from a Medtronic study manager
* Subject has any medical condition that would limit study participation
* Subject is pregnant, or of childbearing potential and not on a reliable form of birth control. Women of childbearing potential are required to have a negative pregnancy test within 7 days prior to the ASD2 Acute Testing procedure
* Subject meets exclusion criteria required by local law (e.g. age, breast feeding,etc.)
* Subject is legally incompetent

  1. Screening subjects at high risk for infection will be based on the local investigator judgment decision.
  2. Subjects who are at high risk for stroke should be screened according to local country guidelines or, in case of their absence, according to ACC/AHA/ESC 2006 Guidelines for High Risk Factors for Stroke (i.e. exclusion of subjects with previous stroke, TIA, or embolism; Mitral stenosis; prosthetic heart valve).
  3. Screening will be based on the local investigator judgment decision.
Transcutaneous Bilirubin Measurements in Neonates Post Phototherapy

Can transcutaneous bilirubin (TcB) measurements be utilised to assess rebound hyperbilirubinaemia following phototherapy in neonates?

Jaundice is common in the newborn and may result in the need for babies to be readmitted from home for phototherapy, with associated increased costs and significant family distress.

As well as prolonged hospital stay, neonates on phototherapy require multiple blood tests (SBR), generally acquired via heel prick testing. These cause the baby discomfort and samples may be insufficient or haemolyzed and require repeating. There is also a delay of one to two hours at best in results being received and actioned.

Jaundice measurements can also be obtained using non-invasive, cheap and reliable meters (TcB) that give almost immediate results. The meter takes one to two minutes to get a result and can be used at the cotside. TcB causes the baby no significant discomfort.

TcB meters are commonly used before phototherapy but are not routinely used during or after stopping phototherapy. Jaundice commonly worsens after stopping phototherapy due to release of bilirubin from tissues and so measuring a "rebound" SBR twelve hours after stopping phototherapy and before the baby can go home is routine practice.

TcB meters tend to underestimate SBR in the first eight hours after stopping phototherapy but there is some evidence that thereafter they may provide reliable results. If TcB measurements can be used as a reliable predictor for SBR twelve hours after phototherapy, this will reduce blood sampling and costs, causing less distress to the baby and their mother, with potential for earlier discharge home. The NICE guideline for neonatal jaundice suggests that new research is needed to evaluate the accuracy of different transcutaneous bilirubinometers in comparison to serum bilirubin levels in all babies.

Eligibility Criteria:
Inclusion Criteria:

* Well neonates
* 35+0 weeks gestation or greater, over 24 hours old
* Inpatients at Princess Royal Maternity (PRM), NHS Greater Glasgow and Clyde

Exclusion Criteria:

* Unwell neonates
* Less than 35+0 weeks' gestation
* Less than 24 hours old
* Mother unable or too distressed to give informed consent
SEMPERFLO* Pain Management System in Inguinal Hernia Repair

This study will compare the clinical performance of the SEMPERFLO\* Pain Management System with another commercial pain relief system using 0.5% bupivacaine following unilateral, open, inguinal hernia repair procedures.

\*Trademark

Pain will be evaluated up to 5 days after surgery Subjects will be followed for 30 days after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Subject is a candidate for primary, non-emergent unilateral, open inguinal hernia repair procedure
* Subject is 18 years or older
* Subject must be willing to participate in the study, and provide informed consent to participate.

Exclusion Criteria:

* Subjects undergoing recurrent hernia repair;
* Subjects who plan to undergo another elective surgical procedure prior to the completion of this study;
* Subjects with known allergy to bupivacaine;
* Subjects with immunodeficiency diseases (including known HIV);
* Subjects with any findings identified by the surgeon that may preclude conduct of the study;
* Subjects who are known current alcohol and/or drug abusers;
Perioperative Pain Control With Celecoxib (Celebrex) in Total Knee Arthroplasty

We propose that administration perioperative celecoxib is effective to control postoperative VAS pain scores, improve rehabilitation results, and decrease narcotics usage in total knee replacement patients.

Total knee replacement is an effective method to treat end-stage osteoarthritis. However, post-operative pain is still a bothering problem. Pre-emptive analgesia is defined as an antinociceptive treatment which prevents pain before its onset. Preoperative analgesia is thought more effective than an equal post-operative dose. Surgical trauma induces the synthesis of prostaglandins, which sensitize the peripheral nociceptors.Non-steroidal anti-inflammatory drugs (NSAIDs) inhibit prostaglandin synthesis both in the periphery and the spinal cord, therefore decreasing the post-operative hyperalgesic state.

Celebrex (Celecoxib) is a nonsteroidal anti-inflammatory drug (NSAID) that is used to treat arthritis, pain, menstrual cramps, and colonic polyps. Prostaglandins are chemicals that are important contributors to the inflammation of arthritis that causes the pain, fever, swelling and tenderness. Celecoxib blocks the enzyme that makes prostaglandins (cyclooxygenase 2), resulting in lower concentrations of prostaglandins. As a consequence, inflammation and its accompanying pain, fever, swelling and tenderness are reduced. Celecoxib differs from other NSAIDs in that it causes less inflammation and ulceration of the stomach and intestine (at least with short-term treatment) and does not interfere with the clotting of blood.

The study group received 400mg oral celecoxib about 1 hr prior to total knee replacement surgery, and 200mg every 12 hrs, along with PCA morphine, over the first five post-operative days. The control group received placebo, along with PCA morphine over the same postoperative period. All patients had spinal anesthesia and hemovac drain tubes inserted for postoperative blood loss evaluation.

Specific aims and goals:

1. to establish better rehabilitation results and lower VAS pain scores after administration perioperative celecoxib in total knee replacement patients.
2. to establish morphine sparing effect after perioperative celecoxib administration.
3. to evaluate the risks after prescribing perioperative celecoxib.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving total knee replacement will be recruited in this study.

Exclusion Criteria:

* subjects with end-stage renal disease, cerebral vascular accident, peptic ulcer, long-term usage of NSAIDs.
Impact of Vaccenic Acid Consumption on the Metabolism of Saturated Fatty Acids: Relationship With Cardiovascular Risk Factors

The investigators' project has for principal objective to evaluate the impact of three specific ruminant milk fats with a Trans Fatty Acid content ranging from 2.9% to 12.2% obtained by modification of the cow's diet on cardiovascular risk factors in healthy subjects.

111 healthy, normolipemic men and women (18y to 50y) have been recruited for a monocentric, randomised, double-blind, controlled 4-week study. All the volunteers consumed 3 experimental products (butter, dessert cream and cakes) made with one of the 3 specific milk fats up to 55 g fat/day.

Eligibility Criteria:
Inclusion Criteria:

* HDL cholesterol, g/L \> 0.4
* Triacylglycerol g/L \<1.50
* LDL Cholesterol g/L \<1.60
* Waist size \< 94 cm (men) or 80 cm (women)
* Affiliated to National Health Insurance
* Normal blood pressure (diastolic \<90 mm Hg, systolic \<140 mm Hg)
* For women: effective contraception
* Subject giving his/her written informed consent
* Subject willing to comply with the study procedures

Exclusion Criteria:

* Reported food allergies
* Currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study
* Hepatic or renal impairments
* Positive serologies to HIV or HCV,
* Blood donation done less than 2 months before the start of the study
* Chronic pathologies
* Refusal to be registered on the National Volunteers Data file
* Being in exclusion on the National Volunteers Data file
Tranexamic Acid to Reduce Infection After Gastrointestinal Surgery

This international, multicentre, pragmatic, double-blind, placebo-controlled, randomised trial of TxA versus placebo will enrol 3,300 patients throughout Australia and internationally. This is an effectiveness trial - some elements of the trial are deliberately left to the perioperative clinicians' discretion in order to reflect usual practice and maximise generalisability.

Study Aims: To conduct a large, multicentre clinical trial of tranexamic acid (TxA), an antifibrinolytic drug routinely used to reduce bleeding in cardiac and some orthopaedic surgery, in 3,300 patients undergoing major gastrointestinal (GI) surgery. Our specific aims are to investigate whether TxA:

Aim 1: Reduces surgical site infection ("wound infection"), and other healthcare-associated infections (pneumonia and sepsis).

Aim 2: Reduces red cell transfusion in GI surgery. Aim 3: Reduces a pooled composite of any serious postoperative complications, and so increases "days alive and at home up to 30 days after surgery" (DAH30).

Aim 4: To evaluate the temporal effect of TxA on perioperative immune and inflammatory responses.

Study Hypothesis Prophylactic TxA administration in patients undergoing major GI surgery reduces the incidence of surgical site infection (SSI) after surgery when compared with placebo.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients scheduled for elective or semi-elective (inpatient) open or lap-assisted GI surgery (oesophageal, gastric, hepatobiliary, colorectal) with one or more risk factors for complications:

* Age ≥70 years
* ASA physical status 3 or 4
* Known or suspected history of: heart failure, diabetes, peripheral vascular disease, or chronic respiratory disease
* Obesity (BMI ≥30 kg/m2)
* Anaemia (preoperative haemoglobin \<130 g/l in males and \<120 g/l in females)
* Renal impairment (se. creatinine ≥150mol/l)
* Low albumin (\<30 g/L)

Exclusion Criteria:

* Poor spoken and or written language comprehension
* Laparoscopic cholecystectomy and other minor (eg. closure of stoma) surgery
* Pre-existing infection/sepsis
* Known history of: spontaneous pulmonary embolism, arterial thrombosis familial thrombophilia (e.g. Lupus anticoagulant, protein C deficiency, factor V Leiden)