cyrilzakka/clinical-trials huggingface dataset:
A Pilot Comparison Study of Vibrating Mesh Versus Standard Jet Nebuliser for Bronchodilator Delivery in COPD

Treatment of chronic obstructive pulmonary disease (COPD) incorporates various modes of inhalation therapy. The response to treatments is dose dependent thus applying the most efficient device to administer the treatment is integral. Evaluation of the efficacy of nebulisation devices in the treatment of COPD is limited. Technological development in recent years has led to new devices that optimize lung deposition and reduce the time needed for treatment.

The aim of this study is to compare the vibrating mesh and jet nebuliser methods of delivering bronchodilator medication to patients hospitalised with an acute exacerbation of COPD, with respect to lung function and efficacy in spontaneously breathing patients.

Treatment of chronic obstructive pulmonary disease (COPD) incorporates various modes of inhalation therapy. The response to treatments is dose dependent thus applying the most efficient device to administer the treatment is integral. Evaluation of the efficacy of nebulisation devices in the treatment of COPD is limited. Technological development in recent years has led to new devices that optimize lung deposition and reduce the time needed for treatment.

The aim of this study is to compare the vibrating mesh and jet nebuliser methods of delivering bronchodilator medication to patients hospitalised with an acute exacerbation of COPD, with respect to lung function and efficacy in spontaneously breathing patients.

Patients admitted to hospital with an exacerbation of COPD and prescribed regular nebulised bronchodilators (combined salbutamol 2.5mg and ipratropium 0.5mg) will be recruited to the study. On one occasion between day 3-7 of admission they will perform pulmonary function testing namely measurement of Forced Expiratory Volume in 1 second(FEV1), Forced Vital Capacity (FVC), Inspiratory Capacity (IC) and cough peak flow. They will also complete the Borg breathlessness score. Measurements will be recorded at baseline (pre-bronchodilator administration) and one hour post-nebulised bronchodilator.

Patients will be randomised to receive their nebulised bronchodilators via the standard hospital jet nebuliser or via a vibrating mesh nebuliser(Aerogen Solo).

Change in lung function and symptom measures between baseline and one-hour post nebulisation will be analysed to look for any significant difference between the two groups

Eligibility Criteria:
Inclusion Criteria:

* Hospital Inpatients admitted with an acute exacerbation of COPD
* Age \>40
* COPD Stage 2-4 moderate to severe (FEV1/FVC \<0.70;FEV1\<80%)
* History of physician-diagnosed COPD
* COPD exacerbation between day 2 and day 7 of admission

Exclusion Criteria:

* Confusion
* Significant hypoxia/unstable medical condition
* Allergy or contraindication to salbutamol and/or ipratropium
* Pneumonia
* Pregnancy
Scheduled or As Needed Pain Regimen?

The aim of this study is to determine feasibility of a randomized controlled trial and estimates of efficacy for pain control of a scheduled pain regimen versus an as needed pain regimen for participants undergoing same day surgery procedures.


Eligibility Criteria:
Inclusion Criteria:

* Any outpatient surgeries performed at Cape Fear Valley Medical Center by Dr. Van Fossen during the duration of the study, including: laparoscopic cholecystectomy, laparoscopic appendectomy, laparoscopic ventral/umbilical/incisional hernia repair, open ventral/umbilical/incisional hernia repair, laparoscopic inguinal hernia repair, open inguinal hernia repair, lumpectomy, sentinel lymph node biopsy, lymph node biopsy, mass excision skin or subcutaneous, diagnostic laparoscopy, laparoscopic lysis of adhesions, pilonidal cyst excision, hemorrhoidectomy, anal fissure/sphincterotomy, anal fistulectomy, rectal exam under anesthesia, wound debridement, and wound closure
* Outpatients who are medically eligible to receive the standard post surgery medication protocol (the scheduled pain protocol used in this study).
* Age 18-65

Exclusion Criteria:

* Participants with the following conditions will be excluded from our study: fibromyalgia, chronic pain, cancer (except for breast cancer). This is because these participants have pain at baseline and it will be difficult to discern if their pain is from surgery or their chronic condition.
* Participants on chronic pain medications will also be excluded from our study because it will be difficult to tell if their pain control is related to their established regimen or the one we are implementing.
* If participants who are not fluent in English, because all study materials are in English.
* Participants with stage 3 Chronic Kidney Disease or higher will also be excluded from the study as they cannot take ibuprofen (according to National Kidney Foundation), which is included in our pain regimen.
IVF Versus Surgery for Endometriosis Related Infertility

The management of endometriosis-related infertility remains controversial. In particular, there is an equipoise for infertile women with endometriotic lesions detected at ultrasound. These women can be managed with either surgery or in vitro fertilization (IVF). The two approaches radically differ and they have never been compared with a randomized trial. As a consequence, affected women currently receive contrasting information and the mode of treatment substantially differ among centres, reflecting the local expertise of physicians rather than clinical needs.

The present study aims at clarify whether IVF could be superior to surgery in infertile women with endometriotic lesions detected at ultrasound. This topic will be addressed comparing the two approaches in terms of effectiveness and cost-effectiveness. In addition, the study will disentangling whether the endometriosis-related systemic inflammatory mechanisms may have an impact on the quality of folliculogenesis and on IVF outcomes. This specific objective will be pursued through the characterization and analysis of circulating extracellular vesicles (EV)-immunologic, proteomic and miRNA signatures and measurement of steroid hormones in follicular fluid.

Women accepting to enter the study will be randomized to either surgery and then natural pregnancy seeking or a program of three complete IVF cycles (i.e. three oocytes retrievals regardless of the number of embryo transfers performed). The initial time point will be the time of randomization. Women of both study groups will initiate treatment (surgery or IVF) in a shortest delay, maximum 3 months. Only live birth pregnancies and initiating within a 12-months period starting from this time point will be included in the primary outcome.

Eligibility Criteria:
Inclusion Criteria:

* Age \< 40 years
* Pregnancy seeking for more than 12 months
* Regular menstrual cycle, i.e. mean cycle interval between 21 and 35 days
* Ultrasonographic diagnosis of ovarian endometriomas or deep peritoneal endometriosis.
* Normal seminal analysis based on WHO criteria
* Absence of ureteral stenosis or intestinal subocclusive symptoms

Exclusion Criteria:

* Previous surgery for endometriosis
* Previous IVF cycles
* Contraindication to pregnancy
* Hydrosalpinx
* Endometriomas with a mean diameter \> 4 cm
* Submucosal fibroids or large intramural or subserosal fibroids (≥ 5 cm).
* Doubtful sonographic findings that do not allow to reliably rule out malignancy.
* Obstacles to regular sexual intercourses (sexual disturbances or logistic problems)
Kidney Function in Diabetics During CPB (Cardio Pulmonary Bypass)

Filtration of urine in the kidney requires sufficient oxygen supply. The filtration of urine is greater in patents with diabetes. Our theory is that the diabetic kidney has a higher oxygen demand than the non diabetic kidney thereby making the diabetic kidney more sensitive to decreased oxygen delivery following reduced blood flow. With a catheter inserted into the kidney vein we will monitor the blood flow and oxygen saturation before and during CPB, in patient with diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Patients with diabetes mellitus
* Serum creatinine \< 150 micromol/L preoperative
* Heart surgery requiring CPB
* LV (left ventricle) EF \>40 %
* Normal hemoglobin

Exclusion Criteria:

-
A Tiered Management System of Osteoporosis in China

There is a management gap in China. This study aims to establish a tiered management system of osteoporosis for Chinese patients. Including:

1. Developing a national hierarchical health management network platform for middle-aged and elderly osteoporosis patients. With this platform, the data of medical records, laboratory results would be shared between medical institutions. And primary hospitals can refer the patients to the nearest medical centre for advanced auxiliary examinations and diagnosis.
2. Establishing a muti-level hospital collaboration, doctor-patient interaction management model of osteoporosis.
3. To explore and establish a early warning and screening pathways for osteoporosis.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women or men aged 50 years or older

Conform to the diagnosis of osteoporosis or osteopenia as followings:

1. Bone mineral density measured by dual-energy X-ray absorptiometry show a T-score ≤ -1.0 at neck of femur or total hip or lumber 1-4 OR
2. Have at least once major osteoporotic fracture

Exclusion Criteria:

* Screened people who do not meet the inclusion criteria
Pharmacokinetic (PK) and Tolerance Study of Natroba Topical Suspension in Pediatrics With an Active Head Lice Infestation

A pharmacokinetic and tolerance study of Natroba (spinosad) Topical Suspension, 0.9% in pediatric subjects 6 months to 4 years of age with an active head lice infestation.

A Postmarketing Requirement Protocol, multicenter, open-label study in pediatric subjects 6 months to 4 years of age with an active head lice infestation designed to determine the topical absorption and safety of Natroba (spinosad) Topical Suspension, 0.9% for a single, 10 minute treatment for spinosad (Spinosyn A and Spinosyn D) and benzyl alcohol.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, 6 months to 4 years of age.
2. Subjects must have had an active lice infestation including live lice.
3. Individuals in otherwise good general health, free of any systemic or dermatologic disorders which, in the opinion of the Principal Investigator or designee, would interfere with the study results or increase the risk of adverse events.
4. A parent (or guardian) must have signed an Informed Consent Form to allow any child to participate in the study.
5. Subjects must have been available to stay in the clinic for blood draws. Parents or guardians must have been available to stay in the clinic, with the subject, for the entire duration of the study.
6. Subjects must have had veins capable of insertion of a Heplock catheter or withstanding multiple blood draws as determined by the Principal Investigator or qualified phlebotomist.
7. Normal values (at screening) for serum chemistry and hematology for subjects, unless the principal Investigator or qualified medical designee determined that the abnormal value was not clinically significant.

Exclusion Criteria:

1. History of irritation or sensitivity to pediculicide or hair care products or ingredients.
2. History of known allergy or sensitivity to topical anesthetics including lidocaine and prilocaine.
3. History of allergy or sensitivity to Heparin.
4. Systemic diseases that could have interfered with the results of this study as determined by the Principal Investigator or designee.
5. Any condition or illness that, in the opinion of the Investigator or designee, may have compromised the objective of the protocol or the safety of the subject.
6. The use of antibiotics or other systemic medications within 2 weeks of the screening visit, which in the opinion of the Investigator or designee could have interfered with the outcome of the study.
7. Participation in a previous drug study within the past 30 days.
8. Individuals with any visible skin/scalp condition (other than from an active lice infestation) at the treatment site which would have interfered with the evaluations according to the opinion of the Investigator or designee.
9. Parents or guardians who, in the opinion of the Investigator, did not understand their child's requirements for study participation and/or may be likely to exhibit poor compliance.
New Pediatric Patching Method to Improve Compliance

This project will assess whether there is a significant difference in compliance with patching in amblyopic patients whose parents are instructed to pinch the superior and inferior edges of the patch before applying (in order to improve comfort) versus patients whose parents are instructed to place the patch evenly around the orbit.

Patients will present to the pediatric ophthalmology clinic at Texas Children's Hospital. If during the course of their standard care visit it is determined by their pediatric ophthalmologist or optometrist that patching is indicated and that the patient meets eligibility criteria for the study, the eye doctor will explain to the patient's parents the need for patching according to the standard protocol and will then mention to them the study being conducted. If they are interested, an investigator will explain the study, allow patients and parents to ask questions, and will then seek written informed consent. Upon consent, a patient will be assigned an ID code that will be written on their signed consent form. Consenting parents will then be randomized into either the control group (taught to apply the patch using the standard method) or the study group ( taught to apply the patch using our modified technique). The standard technique refers to applying the patch evenly and flatly around the orbit, and the modified technique refers to pinching the middle of the superior and inferior edges of the patch before applying so that the patch is convex and the center is raised above the eye in an attempt to improve patient comfort. All patients will be provided with one box of sample patches. In order to mask parents in both groups, these patches will all have a small incision of 3 millimeters on the lateral edges so that parents will be uncertain if they are assigned to the control or study group. An incision of this size will not significantly alter the function of the patch in any way. Patients will have equal odds of being assigned to either the control or study group using a random number generator. Parents will not be told whether the method they are being taught is the standard or modified method, and their eye doctor will not be told whether or not the parents decided to enroll in the study. After using one full box of patches or after one month, whichever comes first, parents will complete a questionnaire about their compliance with the prescribed patching regimen and any difficulties they may have had in patching their child. We will use the Amblyopia Treatment Index Patching Questionnaire designed by the Pediatric Eye Disease Investigator Group, with the addition of several questions related to patients' comfort while patching. Patients will be instructed to return for standard follow-up care as determined by their eye doctor.

Eligibility Criteria:
Inclusion Criteria:

* Patients prescribed an eye patch by a pediatric ophthalmologist or optometrist to treat either strabismus, anisometropia, or deprivation amblyopia
* Patients aged from birth up to and including 7 years old

Exclusion Criteria:

* Known skin reaction to patch or bandage adhesive
Detection of Familial Hypercholesterolaemia in Cardiovascular Disease Registry

Familial hypercholesterolaemia (FH) is an autosomal dominant somatic mutation commonly located on the LDL-receptor, APOB, and PCKS9 gene. The estimated prevalence of homozygous FH is estimated at 1 in a million, whereas the prevalence of heterozygous FH ranges from 1/500-1/200 (0.2-0.5%) of the general population. The majority of individuals suffering from FH remain undiagnosed and without treatment. Using preexisting clinical guidelines, this study scored patients within national cardiovascular disease (CVD) registries for FH with the aim of evaluating prevalence of FH among individuals suffering from premature cardiac events within the UK.

Following scoring of the registry, this study also examined the relationship between cholesterol and survival after a premature event in order to understand the possible ramifications of untreated FH on patient survival.

Familial Hypercholesterolaemia (FH) is a genetic disorder caused by a mutation in the low-density lipoprotein receptor (LDL-R) gene. Individuals suffering from FH experience elevated cholesterol levels that are outside of the accepted range of healthy cholesterol levels. When left untreated FH may cause complications in cardiovascular health and may cause premature cardiac events. Current screening methods for this disease do not successfully diagnose the majority of FH cases.

This study applies three clinical diagnostic tools--Dutch Lipid Clinic Network Criteria (DLCN-Criteria), Make Early Diagnosis to Prevent Early Deaths (MEDPED) criteria, and the Simon Broome Register Criteria--within national registries in order to define possible, probable, and definite cases of FH. The national registries used for this study are the Myocardial Ischaemia National Audit Project (MINAP) and National Audit of Percutaneous Coronary Intervention (BCIS) audit.

Following scoring of patients, a one-year and 30-day survival model were created in order to assess the effect of elevated cholesterol on survival, as suspected FH patients will have elevated cholesterol levels.

Data within MINAP ranges from 2003-2013 and data from BCIS ranges from 2007-2014.

Patient information within the audits was collected following admission to English and Welsh hospitals following a coronary event or percutaneous coronary intervention (PCI). Information related to survival and mortality was collected annually within each audit.

Participants for this study were those experiencing a premature cardiovascular event or coronary intervention (men \<55 and women\<60).

Eligibility Criteria:
Inclusion Criteria:

* Experienced a cardiac event and is therefore entered in CVD audit
* First registered event within audits

Exclusion Criteria:

* Under age 18
* Previous diagnosis of FH
Pharmaco-metabolomic Effects of Statins: METASTATINE

Statins are effective in cardio-vascular prevention by lowering LDL-Cholesterol levels but also through other mechanisms poorly understood. Our hypothesis is that some of these effects are mediated by microbiota alteration, leading to diminution of expression of microbiota derived pro-atherogenic metabolites.

The aim of this prospective double blind placebo-controlled study is to evaluate the acute effects of statins on microbiota and its derived metabolites at 2 and 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patient with cardiovascular risk requiring statins in primary prevention
* Contraception for women of childbearing age

Exclusion Criteria:

* Previous antibiotics, proton pomp inhibitors, statins or other hypolipidemic drugs intake in the previous three months
* Renal insufficiency with creatinine clearance \<40ml/min
* Contra-indication to statins
* Previously known conditions affecting muscles, or digestive system
* Requirement of statins in secondary prevention
Maternal Serum Pentraxin 3 in Early Pregnancy to Predict Gestational Diabetes Mellitus

To investigate the association of maternal serum concentrations of pentraxin 3 in early pregnancy with gestational diabetes mellitus and to explore its potential value in the prediction of GDM.

We recruited all pregnant women for the first checkup in our hospital . Maternal fasting serum PTX3 levels, fasting plasma glucose and fasting insulin and other factors were measured. Oral glucose tolerance test (OGTT) was performed at 24-28 weeks in all participants. According to the occurrence of GDM, subjects were divided into two groups: GDM group and normal glucose tolerance (NGT) group.

Eligibility Criteria:
Inclusion Criteria:

* Women with maternal age ≥ 18 years, singleton pregnancy, primipara, no smoking, confirmed gestation≤20 weeks and spontaneous conception were invited to participate in the study.

Exclusion Criteria:

* Women were excluded if they had multiple pregnancy, pre-gestational diabetes mellitus (PGDM), hypertensive disorders, preterm delivery, cardiovascular disease, immunological disease, glucocorticoid therapy, or other severe illness. In addition, women who were suffering from fetal abnormalities including chromosomally abnormal fetuses and/or structural defects and fetal growth restriction occurred during pregnancy were also excluded from the study.
Disturbed Blood Flow Induces Endothelial Dysfunction in Severe Chronic Obstructive Pulmonary Disease

The aim of the study is to determine if increased retrograde shear would further deteriorate the already impaired vascular function in severe COPD patients.


Eligibility Criteria:
Inclusion Criteria:

* COPD
* chronic hypoxemia

Exclusion Criteria:

* an acute exacerbation, active respiratory infection or infection of other localisation 6 weeks prior to the visit
* relevant coexisting lung disease such as interstitial lung disease, cancer, renal failure, thromboembolic disease or major cardiovascular event during the previous year
* informed consent not provided or inability to comply with the study protocol
The Usefulness of Growth Differentiation Factor 15 (GDF-15) for Risk Stratification in Cardiac Surgery

Growth determination factor 15 (GDF-15) and high sensitive troponin-t (hsTnT) are emerging humoral markers for risk stratification in clinically stable heart failure patients and in patients with stable coronary artery disease. No data are available about the prognostic value of these peptides in relation to mortality and morbidity in patients undergoing cardiac surgery.

Primary objective of the present study is to test the hypothesis, that GDF-15 is superior to a standard preoperative risk score, the additive Euroscore for the prediction of 30 day mortality and postoperative morbidity in patients scheduled for cardiac surgery.

Secondary objectives are to test the predictive value of hsTNT, either alone, or in combination with GDF-15 and if GDF-15 adds additional information to NTproBNP levels and preoperative cerebral oxygen saturation (ScO2) levels.

The study will be based on 2 patient cohorts, a group of patients studied during an observation period (2009) and a validation cohort of patients studied in 2008. The 2009 cohort (about 800 patients) will be analyzed to determine the predictive value of GDF-15 for predicting mortality and morbidity. The 2008 cohort (about 1200 patients) will be used to validate these findings.

Besides conventional morbidity markers, new sensitive markers of organ dysfunction (FABP, NGAL, sFLT-1, PIGF) will also be tested in the 2009 group.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for cardiac surgery

Exclusion Criteria:

* Withdrawal of informed consent