cyrilzakka/clinical-trials huggingface dataset:
Effects of Long Term Antibiotic Therapy on Exacerbation Rate in Stable COPD Patients

This study investigates if long term use of the antibiotic doxycycline can reduce exacerbations in COPD patients. Half of the patients will receive doxycycline which the other half will receive a placebo.

Chronic Obstructive Pulmonary Disease (COPD) is a common disease which can place a considerable burden on people who suffer from it. COPD exacerbations (periods when symptoms flare up) are a major cause of hospital admission in the UK. Bacterial infections play an important role in the development of COPD and so one possible treatment for COPD is with antibiotics. However, there is little information available about the use of long term antibiotics in the treatment of this disease.

Therefore, the purpose of this study is to investigate if long term use of the antibiotic Doxycycline can reduce exacerbations and improve the outlook for these patients.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent given
* Confirmed COPD diagnosis
* Severity of disease: Patients with a measured FEV1\<80% of predicted normal values.
* At least one treated exacerbation (Patient recalls an episode of symptomatic worsening which was treated and was consistent with a COPD exacerbation) in the previous year.
* Age: ≥ 45 years of age at screening.
* Able to complete questionnaires for health status and symptoms and considered able to comply with the dosing regimen.
* Patients willing to report exacerbations and attend for study visits.

Exclusion Criteria:

* Patients with a known diagnosis of active TB or other chronic respiratory disease in the judgement of the study doctor.
* Hepatic or renal impairment as defined as LFTs \> 5XULN, and eGFR\<30 ml/min/1.73m2.
* Patients with known hypersensitivity to Tetracyclines, the IMP and/or Placebo including their excipients.
* Patients taking ongoing antibiotic therapy for COPD or other conditions.
* Patients with uncontrolled clinically significant hypertension
* Female patients who are pregnant or planning on becoming pregnant during the study, or are breastfeeding.
* Patients with uncontrolled clinically relevant bradycardia, cardiac arrhythmias or cardiac insufficiency.
* Clinically relevant abnormal electrolyes (sodium or potassium), renal function (urea and creatinine) or liver function (ALT, AST, ALP) that could interfere with the objectives of the trial or safety of the volunteer.
* Patient taking clinically significant contraindicated medication, as per the SmPC for Doxycycline.
* Use of another experimental investigational medicinal product within 3 months of study enrolment. If the IMP used was as part of the NIHR WP2 study then entry to WP3 after a 6 week washout period is permissible.
* Patients with any other condition precluding enrolment in the trial, according to the assessment of the study doctor. This will be documented at screening
Lenalidomide and Low Dose Dexamethasone Versus Bortezomib, Lenalidomide and Low Dose Dexamethasone for Induction, in Patients With Previously Untreated Multiple Myeloma

This is a randomized phase III trial of CC-5013 (lenalidomide, NSC-703813) and low dose dexamethasone (LLD) versus bortezomib (PS-341, NSC-681239), lenalidomide and low dose dexamethasone (BLLD) for induction, in patients with previously untreated multiple myeloma without an intent for immediate autologous stem cell transplant.


Eligibility Criteria:
1. Patients must have newly diagnosed multiple myeloma
2. Patients must have received no prior chemotherapy for this disease. Patients must have received no prior radiotherapy to a large area of the pelvis (more than half of the pelvis). Prior steroid treatment is allowed provided treatment was not more than 2 weeks in duration. Patients must not have received any prior treatment with bortezomib or lenalidomide.
3. Patients must be ≥ 18 years of age at the time of registration.
4. Patients must have a Zubrod Performance Status (PS) of 0 - 3
5. Patients must have adequate marrow function as defined herein:
6. Platelet count ≥ 80 x 103/mcL,
7. ANC ≥ 1 x 103/mcL, and Hemoglobin (including patients who have been either transfused or treated with EPO) ≥ 9 g/dL.
8. Institutions must submit a local cytogenetics report and FISH analysis report
9. Patients with pathologic fractures, pneumonia at diagnosis or symptomatic hyperviscosity.
10. Patients must have a calculated or measured creatinine clearance \> 30 cc/min.
11. Patients must not have uncontrolled, active infection requiring intravenous antibiotics
12. Patients must not have any psychiatric illness
13. Patients must not be Hepatitis B, Hepatitis C or HIV positive
14. Patients must not have a history of cerebral vascular accident with persistent neurologic deficits.
15. Patients must be able to take aspirin 325 mg daily
16. Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test
17. No prior malignancy is allowed except for adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which the patient has been disease-free for five years.
18. Patients must be offered participation in GEP molecular studies for the evaluation of genetic polymorphisms.
Biomechanical Determinants of Different Rehabilitation Protocols for ACL Reconstruction

Purpose of the study is to investigate the effects of the criterion rehabilitation protocol versus accelerated rehabilitation protocol on the biomechanical determinants of the quality of performance and risk of reinjury.


Eligibility Criteria:
Inclusion Criteria:

* Amateur male athletes who underwent ACLR surgery with an autologous hamstring (HS) graft.
* Ranging in age from 18 to 35 years.
* Underwent a pre-operative rehabilitation program with minimal knee effusion, full Extension, good patellofemoral mobility
* Ability to actively control the quadriceps.

Exclusion Criteria:

* ACLR with any graft other than a hamstring graft
* ACL revision surgery
* associated medial or lateral ligamentous injuries
* previous meniscectomy or meniscal repair
* simultaneous meniscectomy or meniscus repair with the ACLR
* cartilage damage.
Single-center Prospective Study of Non-invasive Methods for the Diagnosis of Postoperative Complications in Liver Transplant Recipients

A lot of different early and late complications may occur after liver transplantation. They could be related to surgical procedure, to infectious diseases or immuno-mediated diseases (acute cellular rejection, ACR). Almost all of those complications are characterized by an elevation in liver enzymes (ALT, AST and GGT) and a decline of liver function tests (serum bilirubin and INR increase) possibly leading to early allograft disfunction (EAD). In this scenario there is a lack of biomarker that could predict the development of ACR and/or EAD.

The aim of this study is to explore the prognostic role of non-invasive instrumental and biological marker in the early post-transplant phase.


Eligibility Criteria:
Inclusion Criteria:

* Patients eligible for liver transplantation following National and International Guidelines

Exclusion Criteria:

* No agreement or inability to give informed consent

  * Re-transplant patients
  * Liver transplant in fulminant hepatitis
Pascal Pascal Dynamic Contour Tonometer (DCT) Intraocular Pressure and Ocular Pulse Amplitude in Patients With Thyroid Related Orbitopathy: A Comparison to Goldmann Tonometer and to Muscles Characteristics on CT Scan

Thyroid related orbitopathy (TRO) is an autoimmune disease. Clinical features include: orbital pressure pain, ocular soft tissue swelling, muscle enlargement around the eyeball, eyelid retraction and bulging of the eye anteriorly out of the orbit. In many cases, the cornea may become too dry, and as a result, corneal ulcers may form, which can become infected. In severe cases, damage to the optic nerve can occur secondary to optic nerve compression by enlarged muscles in the orbit.

Inflammation with soft tissue swelling occurs in the 1st stage of the disease. Scar formation can occur in the 2nd phase. The muscles under and nasal to the eyeball are most commonly involved. In many patients, intra-ocular pressure (IOP) can increase in primary. IOP in upgaze (when looking up) can increase.

Goldmann applanation is the standard device to measure the IOP. It measures the average IOP (between the "systolic", when the heart contracts, to the diastolic IOP, when the heart relaxes). Pascal Dynamic Contour Tonometer is a new device that can measure IOP and ocular pulse amplitude (OPA) which is the difference between diastolic IOP and systolic IOP. The choroid is a vascular layer inside the eyeball that feeds part of the retina (the retina is like the film in a non-digital camera). OPA is suggestive of choroidal blood flow. IOP measurements using Pascal Dynamic Contour Tonometer are less influenced by corneal thickness as opposed to Goldmann applanation which measures higher values in thicker corneas. In the current study we are interested in measuring the relationships between measurements taken with Goldmann applanation (IOP) and those taken with the Pascal Dynamic Contour Tonometer (IOP and OPA). In addition, we will investigate the effect of orbital muscle enlargement on IOP/OPA following an up gaze position (looking up).


Eligibility Criteria:
Inclusion Criteria:

1. age \> 18 yr
2. agree to participate in the study and willing to sign an informed consent

Exclusion Criteria:

1. other ocular diseases (besides cataract and mild hypertensive retinopathy)
2. previous history of eye surgery besides cataract extraction and Nd:YAG laser capsulotomy
3. moderate to severe cataract that precludes fundus examination
4. pregnancy
Efficacy of IFABONDTM Synthetic Glue for Fixation of Implanted Material in Laparoscopic Sacrocolpopexy: a Prospective Multicenter Study

Laparoscopic sacrocolpopexy is the consensual attitude of choice in genital prolapse but incurs problems of tolerance of implanted material. As an alternative to stapling and suturing, which cause vaginal erosion, we present a fixation technique using a sterile synthetic liquid tissue glue: IFABOND™. A non-randomised prospective multicenter study will assess efficacy in terms of 12-month failure of prolapse correction.


Eligibility Criteria:
Inclusion Criteria:

* Woman aged 18 years or more
* Stage III or IV medial and/or anterior genital prolapse on the Pelvic Organ Prolapse Quantification (POP-Q) classification (hysterocele and/or cystocele), requiring surgical correction
* Patient requesting surgery for the trouble caused by the prolapse

Exclusion Criteria:

* Prolapse of POP-Q stage \<III or without functional impact
* Unacceptable postoperative risk disclosed on interview: coagulation disorder, immune disorder, evolutive disease, etc.
* Impaired lower-limb range of motion preventing positioning for surgery
* Pregnancy or intended pregnancy during study period
* Evolutive or latent infection or signs of tissue necrosis on clinical examination
* Non-controlled diabetes (glycated haemoglobin \>8%)
* Treatment impacting immune response (immunomodulators), ongoing or within previous month
* History of pelvic region radiation therapy, at any time
* History of pelvic cancer
* Non-controlled evolutive spinal pathology
* Known hypersensitivity to one of the implant components (polypropylene)
* Cyanoacrylate hypersensitivity
* Formaldehyde hypersensitivity
* Inability to understand information provided
* No national health insurance cover; prisoner, or ward of court
Misoprostol for NASH

The aim of this randomised control trial is to evaluate the effect of Misoprostol in treating patients with NASH.


Eligibility Criteria:
Inclusion Criteria:

1. Patients between age 25 and 64 years
2. Patients having NAFLD as evident by a radiologic test like ultrasound/fibroscan/CT scan etc.
3. ALT level of 1.5 times ULN
4. If already known case of NAFLD, then patient should be on stable doses of Vitamin E, oral hypoglycemics or anti-lipidemic drugs, with no change in medication during 6 months prior to recruitment.

Exclusion Criteria:

1. Patients with age less than 18 yrs or more than 80 yrs,
2. Women of childbearing age
3. Clinically significant acute or chronic liver disease unrelated to NAFLD
4. Evidence of hepatitis B and C
5. Evidence of primary biliary cirrhosis, primary sclerosing cholangitis, or biliary obstruction
6. Autoimmune hepatitis
7. Drug-induced steatohepatitis (ingestion of drugs known to produce hepatic steatosis including corticosteroids, high-dose estrogens, methotrexate, tetracycline or amiodarone in the previous 6 months)
8. Any cardiovascular event or evidence of active CVS disease
9. Type 1 Diabetes
10. Those consuming alcohol of over 20 grams/day for males and 10 grams/day for females
11. Severe end-organ damage
12. Human immunodeficiency virus (HIV) infection
13. Compensated and decompensated cirrhosis
14. Patients with uncontrolled diabetes
15. Mental instability or incompetence
Reactivation of Inactive Blood Donors

Blood donor retention is a critical strategy to ensure the safety and sufficiency of clinical blood supply. An effective strategy can prevent donors from lapsing and eventually becoming inactive.


Eligibility Criteria:
Inclusion Criteria:

* Donated blood at least once between Januanry 1 to September 30 2016, and the blood test result is qualified.

Exclusion Criteria:

* Having donated again before intervened.
Relationship Between Effect Duration of Rocuronium and Body Composition Analysis Data.

The induction dose of rocuronium is typically decided based on the patient's body weight, but the effect duration of rocuronium is variable. Some studies suggest that body composition analysis data, such as skeletal muscle mass or total body water, may correlate better with the duration time of rocuronium. Therefore, we plan to analyse body composition in patients undergoing total intravenous general anesthesia, give the patients a fixed dose (50mg) of rocuronium, and check the correlation between duration time of rocuronium and body composition analysis data.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with ASA class I-II undergoing total intravenous general anesthesia

Exclusion Criteria:

* too overweight (over 111.11kg, which corresponds to less than 0.45mg/kg of induction dose of rocuronium)
* too underweight (under 41.67kg, which corresponds to more than 1.2mg/kg of induction dose of rocuronium)
* pregnancy
* prediagnosed muscle or nerve related disease
* unsuitable for body composition analysis using bioelectrical impedance method
* unsuitable for neuromuscular block monitoring
Relationship of CP and AP

The present study aimed to determine the prevalence of AP attacks before the diagnosis of CP and further identified the potential associated factors for AP episodes.


Eligibility Criteria:
Inclusion Criteria:

* Consequent patients with a diagnosis of CP between January 2010 to December 2015
* informed consents provided

Exclusion Criteria:

* autoimmune pancreatitis (AIP)
* pancreatic cancer diagnosed within 2 years after the diagnosis of CP
Tracking of Upper Limb Sensory and Motor Recovery in Asian Stroke Survivors

As Singapore's population is aging rapidly, the incidence rate of stroke has been increasing in the past years. Rehabilitation is essential for the resumption of daily activities, and with the appropriate care, it is possible for stroke-survivors to regain most of their functions.

Hence, this study aims to better understand upper limb recovery covering different stages post-stroke in a representative cohort of Asian adults

Stroke is a leading contributor to disability in Singapore, partially driven by a reduced ability to use the upper limb in their daily lives. Reduced upper limb use commonly results from a variety of impairments such as motor, sensory and cognitive impairments.

The aim of this longitudinal and observational study is to gather a rich multi-modal database on the time-course of upper limb recovery in a representative cohort after stroke and characterise the relationship between upper limb recovery, common post-stroke impairments and quality of life.

Eligibility Criteria:
Inclusion Criteria:

1. Stroke confirmed by neurologists, neurosurgeons and brain imaging (CT, CT angiogram, MRI, MR angiogram)
2. First ever confirmed stroke
3. Asian ethnicity
4. Age 21-90 years
5. Montreal Cognitive Assessment (MOCA) scores 21/30 and above
6. Admission to rehabilitation ward is within 8 weeks of stroke onset

Exclusion Criteria:

1. Recurrent stroke or transient ischaemic attack (TIA)
2. Upper limb impairment not related to stroke: e.g., subarachnoid haemorrhage, traumatic brain injury or brain tumours
3. Bilateral upper limb impairment.
4. Uncontrolled medical conditions such as hypertension, hypotension, diabetes mellitus, unstable angina, cardiac failure or sepsis will be excluded.
5. Active fractures or arthritis of upper limb joints/bones
6. Visual Analogue Scale (VAS) pain \> 5/10
7. MOCA \< 21/30
8. Severe behavioural disturbance or agitation or epilepsy or untreated depression
9. Life expectancy \< 6 months
10. End organ failures on replacements (renal dialysis or renal replacement therapies)
11. Minimally responsive or unresponsive awareness (vegetative) states
12. Pregnancy or lactation states
13. Admission to rehab ward later than 8 weeks post-stroke
14. (For TMS assessments only) History of epilepsy or seizures, or cranial surgeries, or have metal implants in body or head, or have implanted electronics, or have metallic valve, or skull fracture or brain injury, or head or brain surgeries.
Assessing the Efficacy and Safety of DEXTENZA in Pseudo Phakic Patients Undergoing Gas Bubble Repair and Laser Following Retinal Detachment

This prospective, open-label, single-center, randomized, investigator-sponsored clinical study seeks to investigate: how will pseudophakic patients respond in terms of objective and subjective outcomes, when treated with Dextenza compared to topical prednisolone acetate following gas bubble repair and laser for RD.

Subjects who have given informed consent and determined to be eligible at screening will be randomized in a 1:1 ratio to DEXTENZA (placed once in the lower punctum) or the use of topical Prednisolone acetate 1% drops (four times daily). They will be observed for a period of 3-months for both pain and inflammation of the eye.

Eligibility Criteria:
Inclusion Criteria:

* Pseudophakic
* Retinal Detachment
* Age 18 years and older
* Scheduled for gas bubble repair and laser surgery following retinal detachment
* Willing and able to comply with clinic visits and study related procedures
* Willing and able to sign the informed consent form

Exclusion Criteria:

* Patients under the age of 18.
* Pregnancy (must be ruled out in women of child-bearing age with pregnancy test)
* Active infectious systemic disease
* Active infectious ocular or extraocular disease
* Obstructed nasolacrimal duct in the study eye(s)
* Hypersensitivity to dexamethasone
* Patients being treated with immunomodulating agents in the study eye(s)
* Patients being treated with immunosuppressants and/or oral steroids
* Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator
Correlation Between SUV on 18F-DCFPyL PET/CT and Gleason Score in Prostate Cancer

Prostate specific membrane antigen (PSMA) is a unique membrane bound glycoprotein, which is overexpressed manifold on prostate cancer cells and is well-characterized as an imaging biomarker of prostate cancer. Positron emission tomography / computer tomography (PET/CT) is a nuclear medicine procedure based on the measurement of positron emission from radiolabeled tracer molecules. 18F-DCFPyL is a tracer for prostate cancer PET imaging which binds to PSMA. The strength of functional imaging methods is in distinguishing tissues according to metabolism rather than structure. Studies have shown that PET/CT imaging with 18F-DCFPyL can detect prostate cancer lesions with excellent contrast and a high detection rate even when the level of prostate specific antigen is low.

The objective of this study is to evaluate if the patient-wide SUVmax on 18F-DCFPyL PET/CT in locoregional and metastatic prostate cancer correlates with histopathologic Gleason score at initial biopsy. It is hypothesized that SUVmax will correlate positively with Gleason score. This is of interest because non-invasive risk stratification may be possible in the future.


Eligibility Criteria:
Inclusion Criteria:

* Resident of Canada
* Male sex
* Age 18 years or older
* Previous diagnosis of prostate cancer with Gleason Score available
* ECOG performance status 0 - 3, inclusive
* Able to understand and provide written informed consent
* Under referring physician's care
* Able to tolerate the physical/logistical requirements of a PET/CT scan including lying supine for up to 40 minutes with the arms above the head and tolerating intravenous cannulation

Exclusion Criteria:

* Medically unstable patients (e.g. acute cardiac or respiratory distress or hypotensive, etc.)
* Patients who exceed the safe weight limit of the PET/CT bed (200 kg) or who cannot fit through the PET/CT bore (70 cm diameter)
* Patients with unmanageable claustrophobia
Drug Administration From Enteral Nutrition Tube

Enteral nutrition protocols are applied in patients who do not have gastrointestinal dysfunction but in whom oral feeding is contraindicated. In these patients, where drug use is also necessary but alternative drug administration routes are not possible, drugs can be given to the patient through enteral nutrition tubes. However, there are studies reporting errors and complications during drug administration from the enteral nutrition tube. With the planned thesis study, it is aimed to develop an evidence-based checklist and to reduce the rate of errors and complications in drug administration through enteral feeding tube with this checklist.

Enteral nutrition protocols are applied in patients who do not have gastrointestinal dysfunction but in whom oral feeding is contraindicated. In these patients, where drug use is also necessary but alternative drug administration routes are not possible, drugs can be given to the patient through enteral nutrition tubes.

When adding drugs to parenteral nutrition admixtures or using concomitant drugs from the same catheter, it has become a general rule to check for drug incompatibility. The same level of care is not taken in drug administration from the enteral nutrition tube. There are studies reporting errors and complications in enteral drug administration in the literature Today, one of the most important parts of corporate culture in healthcare is patient safety. Patient safety is all of the measures taken by health institutions and employees in these institutions in order to prevent the harm that health care services may cause to individuals. The main goal here is; It is the establishment of a system that will protect the patient from possible harm and eliminate the possibility of error due to errors that will prevent the occurrence of errors during care delivery.

The checklists used in recent years are also an evidence-based practice list and have become one of the effective methods used to prevent errors and reduce complications. A checklist standardizes the process, streamlines maintenance delivery, and improves performance to ensure all actions are covered. The checklist allows cross-checking what was done and in what order. These reassurances are important in situations where time is short and distractions.

With this study, it is aimed to develop an evidence-based checklist and to reduce the rate of errors and complications in drug administration through enteral feeding tube with this checklist.

Eligibility Criteria:
Inclusion Criteria:

* Being an intensive care nurse
* Have experience in administering enteral medication
* Administering enteral medication to an adult patient
* Agree to participate in the research

Exclusion Criteria:

* Administering enteral medication to a patient with fluid restriction
* Change of position
* Wanting to leave research