cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety Study of Probucol in Patients With Diabetic Nephropathy

This trial is randomized, placebo-controlled, double blind, double dummy, multi-centre trial.

* Screening period (4 week)
* Double blind treatment period (16 weeks)

1. Usage: 16 week, BID, Prescribed Oral with the breakfast and dinner
2. Dosage:Placebo group: placebo 2 tablets, 16 weeks Probucol 250mg group: probucol 125mg 2 tablets, 16 weeks Probucol 500mg group: probucol 250 mg 2 tablets, 16 weeks

Eligibility Criteria:
Inclusion Criteria:

1. The subject is male or female diagnosed with type 2 diabetes mellitus and must be aged 20 to 75 years at the time of screening visit
2. Urinary albumin excretion \> 300 mg/g Cr at screening visit
3. Subjects administered ACEI or ARB without changing dosage prior to 3 months at the screening visit (if subjects administered ACEI or ARB)
4. Subjects administered statins without changing dosage prior to 3 months at the screening visit(if subjects administered statins) or subjects have no plan to administered to statin(if subjects is not administered statin)
5. 15 mL/min ≤ eGFR ≤ 90 mL min
6. Subjects must be willing and able to give signed and dated written informed consent.

Exclusion Criteria:

1. Type 1 DM or gestational diabetes
2. Subjects on Renal replacement therapy or Renal transplantation prior to Screening visit
3. Ventricular arrhythmia (multiple and multifocal premature ventricular contractions)
4. Cardiac damage (abnormally levels of Troponin I)
5. Subject with medical history of cardiac syncope or primary syncope
6. Has condition that may prolong QTc interval (for man QTc interval\>450msec, for woman QTc interval\>470msec) at screening
7. Pregnant or lactating woman before randomization
8. Inflammatory bowel disease (ulcerative colitis, Crohn's disease)
9. Cholestasis
10. Congestive heart failure
11. Subjects with a myocardial infarction, Unstable angina, or cerebral infarction within the latest 6 months
12. Subjects has a diagnosis of NYHA grade III-IV status
13. AST or ALT is 3.0 times higher than the upper limit of the normal range
14. Active hepatitis Or Liver cirrhosis
15. Subjects with Hyperkalemia (K\>5.5 mEq/L)
16. Subjects with Renal Artery stenosis
17. Subjects with Malignancy within the 5 years at the time of screening visit(except for treated Basal cells carcinoma or squamous cell carcinoma)
18. Urinary tract disease (urinary tract infection, Neurogenic bladder)
19. Kidney disease (nephritis, chronic glomerulonephritis or polycystic kidney disease)
20. Has an allergic history to probucol
21. HbA1c \> 9%
22. Systolic blood pressure ≥ 160 mmHg or Diastolic blood pressure ≥ 100 mmHg
23. Subjects taken probucol within 3 months prior to Screening
24. The subject has received an investigational product or biological agent within 3 months prior to screening
25. Subjects otherwise judged by the investigator or sub investigator to be inappropriate for inclusion in the trial
Single Arm Post-marketing Study of SC20 Colonoscope

The objective of the study is to gather post-market data regarding the performance of the invendo SC20 colonoscope in a real-world US population.

The objective of the study is to expand data collection and product exposure in a controlled clinical setting and gather data regarding the performance of the Invendo SC20 colonoscope in a real-world US population. The objective of the study is to specifically monitor three points:

1. The diagnostic performance of the device including polyp and adenoma detection rates;
2. The therapeutic performance of the device (the ability of the physician to remove/biopsy identified lesions);
3. Performance of the device in a typical colonoscopy population, including patients with underlying inflammatory bowel disease (IBD), previous pelvic surgery or irradiation, obesity, diverticular disease, and previous colorectal surgery, as they present in the study population (see below C.).

Eligibility Criteria:
Inclusion Criteria:

* Any indication for colonoscopy
* Willing to give informed consent
* Willing to consume 2-4 liters of bowel prep

Exclusion Criteria:

* An age younger than 18 years
* Congestive heart failure
* Renal insufficiency
* Intestinal obstruction
* Any acute life-threatening condition (in the opinion of the investigator)
* Current pregnancy
* Abdominal surgery in the past 6 months
* Bleeding disorders
* Inability to provide informed consent
* Any other contraindication to colonoscopy (e.g. fulminant colitis or acute diverticulitis)
High Dose Ace Inhibitor Therapy Versus Combination of ACE and ARB Therapy

Investigation of wheather addition of angiotensin receptor blocker (Irbesartan) to recommended doses of angiotensin converting enzyme inhibitor (trandolapril) is more effective in decreasing amount of protein in urine in patients with diabetic kidney disease than high doses of trandolapril.


Eligibility Criteria:
Inclusion Criteria:

1. Early diabetic nephropathy as defined by proteinuria between 500mg/24hr and 3g/24hr and GFR\&gt;50ml/min (as calculated by the Cockcroft-Gault formula), in the absence of clinical and laboratory evidence of other non-diabetic renal disease.
2. Controlled blood pressure (\&lt;150/\&lt;90)
3. Able to give informed consent
4. Between the ages of 18 and 75
5. Must be capable of providing a 24 hour urine collection
6. Negative BHcG test for ruling out pregnancy in women of childbearing age
7. Currently taking an angiotensin converting enzyme inhibitor

   -

Exclusion Criteria:

1. Creatinine clearance \&lt;50ml/min or 24hour protein excretion \&gt;3gm/d.
2. Hypotension as defined by the inability to add an ARB or increase ACE-I dose secondary to hypotensive symptomatology or a systolic Bp \&lt;100mmHg.
3. Serum potassium \&gt;5.5 on two separate occasions in the previous six months
4. Previous adverse reaction to angiotensin receptor antagonist medication
5. Use of NSAIDS including COX2 inhibitors
6. Pregnant or nursing women will be excluded
7. Currently taking an angiotensin receptor antagonist

   -
Early Incidence of Occupational Asthma Among Bakers, Pastry-makers and Hairdressers

Background: Occupational exposures are thought to be responsible for 10-15% of new-onset asthma cases in adults, with disparities across sectors. Because most of the data are derived from registries and cross-sectional studies, little is known about incidence of occupational asthma (OA) during the first years after inception of exposure. This study focuses on this early asthma onset period among young workers in the bakery, pastry making and hairdressing sectors in order to assess early incidence of OA in these "at risk" occupations according to exposure duration, and to identify risk factors of OA.

Methods: This study is a longitudinal retrospective study with a nested case-control to identify risk factors of OA. The assessment of incidence evolution is made by exploring a series of promotions (or retrospective cohorts) with increasing duration since at work. The study population is composed of subjects who graduated between 2001 and 2006 in sectors where they experience exposure to organic or inorganic allergenic or irritant compounds (with an objective of 150 subjects by year) and 250 young workers with no specific occupational exposure.

This study is a descriptive, monocentric, longitudinal and retrospective study with cross-sectional measurements.


Eligibility Criteria:
Inclusion Criteria:

* for the exposed group: to be graduated between 2001 and 2006 from nine vocational schools in Lorraine, North-Eastern France
* for the "non-exposed" group: to be graduated in 2001 in the sale or the food sectors (butcher, pork butcher, caterer, cook job,...) from the same vocational schools

Exclusion Criteria:

* asthma diagnosed before apprenticeship
* for the "non-exposed" group: to have worked previously or later in a sector at risk with OA
Soft Contact Lens Fitting With Different Sagittal Height

To evaluate whether there is a difference in subjective and objective fit of soft lenses with different sagittal height


Eligibility Criteria:
Inclusion Criteria:

* Age more than 18 years
* No active eye disease
* 5 soft lenses for the experiment can be successfully worn and all examinations can be completed as required

Exclusion Criteria:

* Active eye disease
* BCVA less than 20/25
* Those who are too small or tight eyelids are not suitable for wearing soft lenses
Video Assisted Study of Salbutamol Response in Viral Wheezing

The study is video assisted cross-over study evaluating the effect of inhaled salbutamol in wheeze in children 6-24 months old.

The object of the study is to evaluate the effect of inhaled salbutamol in wheeze in children 6-24 months old.

In despite of the lack of evidence of salbutamol, it is considered the gold standard in acute wheezing. Placebo-controlled study would be unethical so all participants are treated with salbutamol based on current guidelines. Instead, participants serve as control subjects of their own which is executed by a type video assisted cross-over study.

Participants are filmed before and after the treatment. Afterwards a panel of pediatricians not participating in the treatment of the participants independently evaluates the difficulty of the wheeze. Videos are randomly arranged and members of the panel are blinded to the time point (before/after) of videos.

In addition, collected videos are analyzed using machine vision. Biosignals are collected from the videos and evaluated using algorithms in order to show that machine vision can be utilized to evaluate the difficulty of wheezing. The machine vision analysis is compared to the evaluation of the panel of pediatricians.

Eligibility Criteria:
Inclusion Criteria:

* Wheezing
* Salbutamol-treatment in emergency department prescribed

Exclusion Criteria:

* Need for immediate resuscitation
* Immediate transfer to ICU
* Suspicion of pneumonia based on the auscultation finding
* Suspicion of airway foreign body
A Study in Patients With Advanced Parkinson's Disease to Assess the Relative Bioavailability of Levodopa Administered as ND0612 Subcutaneous Infusion Versus Levodopa Administered as Carbidopa-Levodopa Enteral Suspension

This study will assess the relative bioavailability of s.c. infused ND0612 versus jejunally infused CLES in patients with advanced PD.

This study will be an open-label, randomized, crossover study to assess the relative bioavailability of s.c. infused ND0612 versus jejunally infused CLES in patients with advanced PD.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Advanced PD treated with LD/CD at a dose of at least 800 mg LD
* Female patients must have a negative pregnancy test at screening and at admission.
* Patients must have a body mass index (BMI) within the range of 18.5 - 35 kg/m2, where BMI = body weight (kg) / height (m2) at screening.
* Must be willing and able to communicate and participate in the whole study.
* Must provide written informed consent.
* Must agree to use an adequate method of contraception (per local independent ethics committee requirements).
* Area of administration to be evaluable for local skin reaction (normal skin without skin burns, scars or large tattoos in the area of administration

Exclusion Criteria:

* Any relevant medical, surgical, or psychiatric condition, laboratory value, or concomitant medication which, in the opinion of the Investigator, makes the patient unsuitable for study entry or potentially unable to complete all aspects of the study.
* Positive serum serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV) at the screening visit.
* Patients with a history of drug abuse or alcoholism within the past 12 months prior to screening or positive drugs of abuse or alcohol test result at the screening visit and/or on admission.
* Clinically significant electrocardiogram (ECG) rhythm abnormalities.
* Renal or liver dysfunction that may alter drug metabolism including: serum creatinine \>1.5 mg/dL, serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>2 x upper limit of normal (ULN), total serum bilirubin \>2.5 mg/dL.
* Psychiatric, neurological or behavioral disorders that may interfere with the conduct or interpretation of the study, including dementia, or patients who are considered to be violent or at suicidal risk by the Investigator.
* Blood loss of greater than 500 mL within the previous 3 months prior to first dosing.
* use of any medication from the prohibited concomitant therapies
The Incidence of Respiratory Symptoms Associated With the Use of HFNO

Optiflow (high flow humified nasal oxygen) is used in several settings frequently (ICU, during elective general anaesthesia- commonly here on the TOE list, in certain ENT patients, and more commonly now in obese or obstetric patients for preoxygenation). To the investigators knowledge no one has quantified the common complications associated with it (based on a literature search in November 2017 using PubMed and Google; using the search terms "high flow nasal oxygen" combined with "complications", "side effects", "nasal dryness" and "epistaxis"). The investigators were unable to find any existing research that examined the days following HFNO use and specifically looked for minor side effects) The investigators have had anecdotal feedback from patients that they tend to experience respiratory symptoms post HFNO.

THe investigators would like to determine how often this occurs and how long it lasts for which would be pertinent to consent, and informing patients prior to the procedure, and also serve to improve the literature on this up and coming technique.

The study aims to evaluate what is the frequency and severity of respiratory tract symptoms following the use of high flow nasal humidified oxygen? Participants will be from 2 sub groups:

1. Patients already undergoing TOE (as this is the most common and consistent group who have optiflow- about 4-5 patients per week)
2. Volunteers (staff) who would agree to experience the optiflow whilst awake for the same period as those undergoing TOE

The study will involve a 7 day follow up survey to see if they had experienced complications (runny nose, nasal discomfort, sore throat, epistaxis), what their severity was and how long they lasted for.

Eligibility Criteria:
Inclusion criteria:

1. Volunteers (staff) - from the anaesthetics department and willing to be exposed to HFNO
2. Patients listed for all those undergoing elective TOE requiring sedation and use of HFNO
3. present at Torbay Hospital
4. Greater than 18 years of age. No upper age limit
5. Able to give informed consent

Exclusion Criteria:

1. patient refusal
2. lack of capacity
3. poor understanding of English
4. respiratory tract symptoms
5. blocked nostrils
6. current or recurrent epistaxis
7. nasal steroid treatment
8. Ages \<18 years
9. Unable to give informed consent
Sildenafil Citrate in Waldenstrom's Macroglobulinemia

The purpose of this study is to determine the effects (good or bad) that sildenafil (Viagra) has on patients with slow growing Waldenstrom's macroglobulinemia (WM). Sildenafil blocks the function of several proteins necessary to the survival of certain types of cancer and laboratory tests have shown that it can destroy WM cells.

* Sildenafil will be given orally (at home) at a reduced dose for the first week, then each week for 3 more weeks, the dose will be increased. If the patient has no major side effects, then they will receive the maximal dose for 2 years. If they have major side effects, then the dose of the drug might be lowered or the drug stopped.
* Sildenafil will be continued until their is disease progression or serious side effects.
* While patients are receiving sildenafil, they will be seen in the clinic on months 1,2,9,15 and 21 for blood tests and a subject questionnaire. They will also be seen on months 3,6,12,18 and 24 for a physical exam, blood test, physical assessment test, CT scans of chest, abdomen and pelvis, and a subject questionnaire.
* At the end of the study (month 24) a physical exam, blood tests, physical assessment test and a questionnaire will be conducted.
* Follow-up includes clinic visits at month 27,33,39 and 45 for blood tests and a questionnaire as well as visits at month 30,36,42 and 48 for physical exam, blood tests, physical assessment test, bone marrow aspirate and biopsy, CT scans of chest, abdomen and pelvis, and a questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Clinicopathological diagnosis of Waldenstrom's macroglobulinemia
* Measurable disease, defined as presence of immunoglobulin M (IgM) paraprotein with a minimum IgM level of \> 2 times the upper limit of each institution's normal value
* Slowly progressing disease not requiring therapy for at least 3-6 months
* ECOG performance status 0,1 or 2
* Total bilirubin \< 2 x ULN
* SGOT \< 3 x ULN
* Creatinine \< 2 x ULN

Exclusion Criteria:

* Pregnant or breast-feeding women
* Patients who are using organic nitrates or alpha-blockers
* Grade III/IV cardiac problems
* Resting hypotension (BP \< 90/50) or hypertension (BP \> 170/110)
* Cardiac failure or coronary artery disease causing unstable angina
* Evidence of left ventricular outflow obstruction
* Impaired autonomic control of blood pressure
* Sickle cell anemia
* History of priapism
* Severe and/or uncontrolled medical disease
* Known chronic liver disease
* Currently using ritonavir
* History of retinal pigmentosa
Association Between P0.1 and Extubation Failure in Adult Patients with Acute Hypoxemic Respiratory Failure. a Multicenter Prospective Cohort Study

The goal of this observational study is to learn about the effect of the occlusion pressure during the first 100 miliseconds (P01) over the extubation failure in participants receiving mechanical ventilation for acute respiratory failure.

The main question it aims to answer is:

Are high P0.1 values (≥3 cmH2O) measured 30 minutes after starting a spontaneous breathing trial associated with extubation failure in adult patients who were intubated for acute hypoxemic respiratory failure?


Eligibility Criteria:
Inclusion Criteria:

* Patients over 17 years of age
* Patients receiving invasive mechanical ventilation for more than 24 hours
* Patients who have been ventilated for acute hypoxemic respiratory failure
* Patients who overcome a PVE
* Patients who, after overcoming the PVE, meet the conditions to be extubated immediately after, according to the team of treating professionals who conduct the weaning
* Patients who are in their first attempt at extubation

Exclusion Criteria:

* Tracheostomized patients
* Patients with neuromuscular disease (For example: Guillain Barré,
* Myasthenia Gravis, Amyotrophic lateral sclerosis, etc.)
* Patients with a decision not to reintubate
The Influence of Benign Prostatic Hyperplasia on Bladder Function

Lower urinary tract symptoms(LUTS) are the main symptoms of benign prostatic hyperplasia(BPH), a benign but progressive disease which can advance to be with overactive bladder(OAB) symptoms. Moreover, LUTS and OAB symptoms can badly influence patients' especially the elderly's quality of life. Therefore, it appears to be urge to carry out researches on the functional impairment of bladder along with the advance of BPH. Besides, the management aimed at improving the LUTS and OAB symptoms come to be the key one among the management of BPH. For a long period, medication and surgery sustain to be the two most common therapies for BPH patients. Both patients and urologists prefer pharmacotherapeutics to surgery，which contributes to the rising number of BPH patients companied with OAB symptoms and storing symptoms complaint post-surgery. In fact, investigators usually find bladder impairment macroscopically in the BPH surgery: mild may be the trabeculation, worse can be the cabin, and severe may be the diverticula. Furthermore, it's not uncommon that patients with a long BPH history continually suffer from dysuria after surgery due to the detrusor muscle weakness. Consequently, investigators need to catch a moment when investigators should operate on such a patient in order to harvest a satisfying outcome. And perhaps the moment should be ahead of the existing guideline suggests. Thus, for understanding the influence of BPH on bladder function, investigators plan to conduct a prospective, case-control study recruiting in-patients with different degree of obstruction. Our team wish that such a clinical trail could provide valuable evidence for us to find out relatively better operating timing and serial indications. For the purpose of improving the quality of life and prolong life-span, investigators design the study above to maximum the operating outcome and minimize the bladder dysfunction.


Eligibility Criteria:
Inclusion Criteria:

1. Sign the informed consent.
2. The BPH in-patients who take 'dysuria' as the main self-reported symptom and meet the following conditions, 1) Maximal urinary flow rate less than 20 ml per second, 2) Volume of prostate more than 20ml measured by transrectal ultrasound 3) PSA ranges from 0 to 10ng/ml 4) IPSS\>1

Exclusion Criteria:

1. The lower urinary tract obstruction caused not by BPH
2. Had a history of prostate cancer, surgery for benign prostatic hyperplasia or neurogenic bladder.
3. using medications known to affect urination or had a severe concomitant disease
STAR-LIFE: a Post-market Registry on MINIject

As part of the post-market clinical follow-up (PMCF), this registry is developed to ensure real-world data collection on MINIject device.

The goal of the registry is to collect data of the MINIject in a real-life setting. The registry has 3 main objectives: the collection of real-world evidence on the usability of the device, the patient reported outcomes, and the device safety over a period of 2 years after surgery.

Eligibility Criteria:
Inclusion Criteria:

* 18+ years
* diagnosed with open angle glaucoma, who has been or will be implanted with CE-marked MINIject
* able to give consent

Exclusion Criteria:

* eyes with angle closure glaucoma
* eyes with traumatic, malignant, uveitic or neovascular glaucoma or discernible congenital anomalies of the anterior chamber angle
* patients with known intolerance or hypersensitivity to silicone
* patients unable to give consent