cyrilzakka/clinical-trials huggingface dataset:
Comparison of Subject-driven Titration of Biphasic Insulin Aspart (BIAsp) 30 Twice Daily Versus Investigator-driven Titration of BIAsp 30 Twice Daily Both in Combination With Oral Antidiabetic Drugs in Subjects With Type 2 Diabetes

This trial is conducted in Asia. The aim of this trial is to compare BIAsp 30 twice daily individually adjusted by the subject versus BIAsp 30 twice daily individually adjusted by the investigator both combined with oral antidiabetic drugs (OADs) in subjects with type 2 diabetes inadequately controlled with premixed human insulin. Subjects to continue their OAD background treatment: Metformin plus/minus alpha-glucosidase inhibitor.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
* Type 2 diabetes mellitus (diagnosed clinically) for at least 12 months
* Currently treated with premixed/self-mixed human insulin (proportion of short-acting insulin is equal to or lower than 30%) BID (twice daily) combined with metformin with or without alpha-glucosidase inhibitor for at least 3 months prior to screening visit (Visit 1) with the minimum dose stated: Metformin: at least 1500 mg/day or maximum tolerated dose at least 1000 mg/day (with unchanged dosing within 3 months prior to Visit 1) OR alpha-glucosidase inhibitors: acarbose or miglitol at least 150 mg/day, or voglibose at least 0.6 mg/day
* Total daily insulin dose below 1.4 IU/Kg
* HbA1c above or equal to 7.0% and below or equal to 9.5% (central laboratory)
* Body Mass Index (BMI) below or equal to 35.0 kg/m\^2

Exclusion Criteria:

* Treatment with any insulin secretagogue, thiazolidinedione (TZD), dipeptidyl peptidase-4 (DPP-4) inhibitors and Glucagon-like peptide-1 (GLP-1) receptor agonists within the last 3 months prior to Visit 1
* Previous use of insulin intensification treatment (premixed insulin thrice daily, basal bolus regimen, and continuous subcutaneous insulin infusion (CSII)) for more than 14 days
* Previous use of any insulin other than premixed/self-mixed human insulin (proportion of short acting insulin equal to or lower than 30%) BID within 3 month prior to Visit 1
* Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic episode, during the last 12 months) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months
* Known proliferative retinopathy or maculopathy requiring treatment
Cancer-associated Gene Mutations in CML Treatment With TKIs by NGS

We performed targeted-capture sequencing of 127 known and putative cancer-related genes of patients who best effect to TKIs ,or intolerance to TKIs,or resistance to TKIs by next-generation sequencing (NGS) .


Eligibility Criteria:
Inclusion Criteria:

1. Chronic myeloid leukemia-Chronic phase(CML-CP) patients treated with receiveTyrosine kinase inhibitor -TKI(including imatinib, dasatinib and nilotinib) for more than 1 years
2. best effect to TKIs ,or intolerance to TKIs,or resistance to TKIs according to Q-pcr detected BCR/ABL(IS) in peripheral blood and hematologic response and cytogenetic response
3. Informed consent of the patient or his legal representative

Exclusion Criteria:

1. Patients had history of CML-AP or CML-BC
2. CML Patients who have received allogeneic hematopoietic stem cell transplantation
3. CML Patients who have received immunotherapy (except interferon, including car-t and other cellular immunotherapy)
4. Woman who is pregnant or nursing
Stapled Trans Anal Rectal Resection (STARR) for Outlet Obstruction: Functional and Morphological Outcome

This study compares pre- and postoperative (at 6 month) quality of life and pathomorphology of the pelvis (by MRI defecation) after a STARR procedure for outlet obstruction.

* Trial with surgical intervention


Eligibility Criteria:
Inclusion criteria:

* All patients at our institution treated with the STARR operation

Exclusion criteria:

* Age under 18,
* Chronic or acute inflammatory disease of the bowel or rectum
Minimally-invasive Assessment of Cardiac Output in Severe Preeclampsia

Severe preeclampsia often presents with uncontrolled hypertension and therefore requires close monitoring of blood pressure and cardiac performance.

The purpose of the study is to compare two methods of measuring the performance of the heart in pregnant women: one by ultrasound of the heart, the other by assessing the pulse generated in the blood vessel of the wrist. We hope that the method using pulse analysis will be as effective as ultrasound, which is labour intensive and operator dependant.

Severe preeclampsia often presents with uncontrolled hypertension, which requires close monitoring of blood pressure and cardiac output. It will be very useful to know the cardiac output in this patient population, because it will guide the choice of antihypertensive drugs and measure their effect on cardiac output.

Traditionally pulmonary artery catheters were used to measure cardiac output. There are numerous problems with using this method in severe preeclampsia. These include technical difficulty inserting the catheter in an awake, edematous pregnant patient, potentially causing a pneumothorax, damaging the carotid artery or insertion site infection. There is also an increased risk for cardiac arrhythmias. Apart from the risks, the accuracy of the thermodilution measurements can be influenced by factors such as timing of the injection within the respiratory cycle, temperature of the injectate, speed of injection, and placement of the catheter. A readily available, accurate non-invasive cardiac output measurement technique, that will provide reliable data with fewer risks, is needed.

Doppler ultrasound (trans thoracic echocardiography) is the gold standard for measuring cardiac output non-invasively in pregnant patients. Unfortunately the method is operator dependant, not continuous and not always available when needed most.

Recently a device called the FloTrac has been introduced that measures cardiac output minimally invasively. Attached to an arterial line it measures cardiac output every 20 seconds via arterial waveform analysis. The standard of care for measuring blood pressure in severe preeclampsia requires the placement of an intra-arterial line. This group of patients is therefore ideal for measuring cardiac output with the FloTrac, especially since powerful intravenous anti-hypertensives are used to control blood pressure.

Our hypothesis is that the FloTrac will be comparable to Doppler Ultrasound for measuring cardiac output in severely preeclamptic patients.

Eligibility Criteria:
Inclusion Criteria:

* Severe Preeclampsia
* Arterial Line Required
* Candidates for magnesium sulfate, labetalol or hydrazine

Exclusion Criteria:

* Preexisting cardiac disease
The ASPECT Study - Asian Paclitaxel-Eluting Stent Clinical Trial

The ASPECT study is an Asian multicenter, randomized, controlled, triple-blinded study designed to evaluate the ability of the Cook Incorporated Paclitaxel Eluting Supra G Coronary Stent to reduce restenosis in the coronary artery.


Eligibility Criteria:
Inclusion Criteria:

* Patient must be eligible to undergo planned treatment of a single de novo lesion in a native coronary artery.
* Patient must be an acceptable candidate for coronary artery bypass surgery.
* Patient must have given signed informed consent.
* Patient agrees to return at one month for an office visit to assess cardiovascular status and at 4-6 months for an office visit to assess cardiovascular status and for a diagnostic angiogram.

Exclusion Criteria:

* Patient is less than 18 years old.
* Patient has history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
* The patient is simultaneously participating in another investigative interventional cardiovascular device or drug study.
* Patient has known hypersensitivity or contraindication to aspirin, Clopidogrel, or stainless steel, or a sensitivity to contrast dye that.
* Patient is pregnant.
* Patient has other medical condition that may cause the patient to be non-compliant with the protocol, confound the results or is associated with limited life expectancy.
The Effectiveness of Ultrasound Guided Ozone (O2-O3) Injection With Knee Osteoarthritis

Knee ostheoarthritis (KOA) is a common disabling and degenerative disease leading to painful joints, articular stiffness, and decreased function. The mechanism of the ozone of relieving the pain and improving the knee function is through inhibiting the inflammation reaction in the KOA directly. Actually, the ozone intra-articular injection had been used to relieve the pain caused by KOA.

The aim of this study is to evaluate the effect of intra-articular injection of medical ozone given into the knee of the osteoarthritis patients, and to compare it with intra-articular steroid injection and to investigate the effectiveness of ozone and steroid the job to determine the superiority of the injections to each other.

The study was designed as prospective, randomized, controlled trial. 96 people who met the inclusion criteria were randomized into two groups of people. The first group will be designated as Ozone group will be applied to these patients. Patients in the second group will be designated as the steroid group, and injections will be applied in accordance with protocol. Participants were evaluated with Visual Analogue Scale (VAS), The Western Ontario and McMaster Universities Arthritis Index (WOMAC). The presence of suprapatellar effusion of the participants whose evaluations are completed will be evaluated by ultrasonography and the findings will be recorded. Initial evaluations of the participants will be made before the first injection. Patients in the ozone (O2-O3) injection group will be given intraarticular and per-articular knee injections 3 times as the first dose of 10 μg / ml, the second dose is 15 μg / ml, and the third dose is 20 μg / ml, each session in a volume of 10 ml. In the steroid injection group, 1 ml of betamethasone (6 mg / ml) will be injected once intraarticular knee injection. Patients will be evaluated according to the study criteria at the beginning, 4 and 12 weeks later by a blinded investigator.

Eligibility Criteria:
Inclusion Criteria:

1. Female / male aged\> 45 years
2. Diagnosis of knee ostheoarthritis after physical examination and imaging (direct radiography)
3. Those whose symptoms persist\> 6 months
4. Radiological staging of osteoarthritis according to the Kellgren-Lawrence scale Grade 2 and 3
5. Participation in the study voluntarily and regularly

Exclusion Criteria:

1. History of previous knee surgery
2. Patients with inflammatory arthritis (Rheumatoid arthritis, psoriatic arthritis, gouty arthritis as)
3. Patients with neuropathic pain
4. Those with pain reflected from the waist or hip
5. History of tumor, infectious, psychiatric illness, bleeding diathesis
6. Trauma history within the last 6 months
7. Hyaluronic acid or steroid injection in the last 3 months
8. Those with systemic diseases such as diabetes, rheumatoid arthritis, hepatitis, coagulopathy
9. Those with malignant hypertension
10. Those with G6PDH (Glucose 6-Phosphate Dehydrogenase) deficiency
11. Those with Graves' disease
12. Those with cerebrovascular event disease in which bleeding continues actively
Taste Changes in Acute Otitis Media

Detection of taste changes in Acute Otitis Media (AOM) patients.

Methods:

Taste assessment will be done using Electrogustometer (EGM). Tongue stimulation will be performed using low currents of up to 100uA. Using the protocol as specified in the EGM user manual.

Population: 40 Unilateral AOM patients, aged 8-40. Without chronic otitis media, pregnancy or impaired judgement.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral AOM

Exclusion Criteria:

* Chronic Otitis Media
* Pregnancy
* Patients with lack of judgment
Effect of Probiotics on Testosterone in Men

This study evaluates the effect of L. reuteri ATCC PTA 6475 supplementation on testosterone in men.

The probiotic Lactobacillus reuteri ATCC PTA 6475 has been shown to modulate testosterone levels in mice. It is not known if these effects are seen in humans and this trial is intended to study this.

The aim of this study is to investigate if L. reuteri ATCC PTA 6475 will effect blood testosterone levels in in healthy male subjects 50-65 years of age.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to give signed informed consent for participation in the study.
* Healthy males aged between 50-65 with no known underlying medical conditions
* Subjects who are capable of taking themselves to testing centre at 3 separate timepoints (Baseline, week 6 and week 12).
* Subjects who are available to give fasting blood samples before 10am on day of blood sample collection
* No history of androgen or testosterone supplementation within 6 months prior to study start.
* Subjects who have not been taking antibiotics or probiotic supplements 4 weeks prior to study start 8. Able and willing to comply with the restirictions defined for the study period
* Ability to understand and comply with the requirements of the study, as judged by the investigator physician

Exclusion Criteria:

* Subjects who presently have or have had cardiovascular issues in the past 2 years.
* Subjects who have a Body Mass Index of \< 18 or \> 30
* Known elevated Prostate Specific Antigen levels.
* History of prostate or testicular cancer.
* Nicotine abuse
* Alcohol abuse
Netarsudil Use After Descemtorhexis Without Endothelial Keratoplasty

This will be a prospective assessment of whether adjuvant Netarsudil use in patients undergoing Descemetorhexis without endothelial keratoplasty improves time to corneal clearance and post-operative central endothelial cell counts. The anticipated enrollment is 25 patients.

Subjects meeting inclusion criteria will be identified by Massachusetts Eye and Ear cornea surgeons during their pre-operative assessment and invited to participate in the study. Written informed consent will be obtained from the patient. The patients will then be added to a shared Epic patient list with a shared to-do column (outside of the patient record) indicating their subject ID and date of recruitment. All subjects will be asked to provide their best contact phone number which will be updated in the chart.

Upon obtaining informed consent, subjects will receive a bottle of Netarsudil from the Massachusetts Eye and Ear research pharmacy with post-operative instructions to use the drop once a day at bedtime starting on post-operative day 1 . Each patient will then receive regular, scheduled post-operative monitoring with a post-operative day 1 visit, post-operative week 1 visit, post-operative month 1 visit, and then every 2 month follow up for twelve months. Clinical examination, including best corrected visual acuity and intraocular pressure, will be recorded during every visit. Corneal topography and specular microscopy will be performed during the pre-operative assessment and during each bi-monthly visit in order to monitor for post-operative outcomes.

A retrospective chart review will be performed prior to new patient enrollment for patients who had previously had DWEK and did not receive a rho-kinase inhibitor. These patients will be included for pre-operative and post-operative vision, pachymetry, corneal topography results, and specular microscopy results with minimization of data acquisition as no informed consent can be obtained from these patients.

Eligibility Criteria:
Inclusion Criteria:

* Fuchs corneal dystrophy

Exclusion Criteria:

* Women of childbearing potential
* Other corneal eye diseases
* Non-compliance with netarsudil
* Intolerance of netarsudil
Safety and Efficacy of PHP in the Treatment of Shock Associated With Systemic Inflammatory Response Syndrome (SIRS)

To determine the safety and effectiveness of pyridoxylated hemoglobin polyoxyethylene conjugate (PHP) administered by continuous intravenous (IV) infusion in systemic inflammatory response syndrome (SIRS) patients with shock. PHP is a human-derived chemically modified hemoglobin preparation. PHP selectively scavenges excess nitric oxide (NO) and does so in a catalytic, concentration-dependent reaction that results in the formation of the non-toxic NO metabolite, nitrate. PHP is postulated to reduce excess, toxic levels of NO while allowing critical beneficial levels of the molecule to persist.

This Phase 3, randomized, placebo controlled, multi-center study is designed to evaluate the safety and efficacy of continuous IV infusion of PHP plus conventional vasopressor treatment, as compared to continuous IV infusion of Plasma-Lyte A plus conventional vasopressor, as a treatment for restoring hemodynamic stability in SIRS patients with shock. Conventional vasopressors include dopamine \> 5 mcg/kg/min; or norepinephrine, phenylephrine or epinephrine at any dose.

The study consists of a Screening period, a Pre-Treatment period, and a 28-day Treatment period. Efficacy will be determined by evaluating objective clinical measures of mortality and organ function over the 28-day treatment period.

The safety and tolerability of PHP will be evaluated over the continuous 28 days using a number of measures including an evaluation of:

* all cause mortality,
* median patient survival time and
* adverse event rates and duration.

Eligibility Criteria:
Determination of study eligibility will be made by the Investigator on the basis of the inclusion criteria listed below:

SIRS Inclusion Criteria

Patients with SIRS as characterized by two or more of the following conditions (worst values in a 24 hour period):

* Either respiratory rate \>/= 20 breaths/minute, partial pressure of arterial carbon dioxide (PaCO2) \</= 32 torr, or mechanical ventilation,
* Heart rate \>/= 90 beats/minute,
* Either hyperthermia \>/= 38 degrees C, or hypothermia \</= 36 degrees C or
* Either white blood cell (WBC) \>/= 12,000 cells/mm3, \</= 4,000 cells/mm3, or \>/= 10% immature (band) forms

Shock Inclusion Criteria Patients with adequate fluid resuscitation (PCWP \>/= 12mmHg) and with one or more conventional vasopressors (continuing up to the time of randomization) being used to treat hypotension (MBP \< 60 mmHg or SBP \< 90 mmHg). Patients cannot be entered if they have been in shock for more than 24 hours.
Retrospective Data Analysis of VitalCare Targeted Population Management on Scott and White Chronically Ill Beneficiaries

New payment methods such as Accountable Care Organization (ACO's) and medical homes facilitate are new models for providers to deliver cost effective, quality patient outcomes. Integrated Care Coaching (ICC) is a healthcare delivery model combining telephonic interventions with an intelligent information technology platform that offered validated protocols and patient outcomes tracking. Health Integrated, Inc. has developed a validated program of Integrated Care Coaching (ICC), which was branded as "VitalCare", and implemented with over 7,000 members of the Scott and White Health Plan in Texas, would reduce healthcare costs/achieve a return on investment (ROI), improve clinical outcomes, and be satisfying for participants.

A prospective, pre-post historical control design trial with a concurrent control group cost/satisfaction analysis with a retrospective clinical study was undertaken with adult, Scott and White Health Plan (SWHP) patients with chronic illnesses. From 2007 to 2010, a total of 7,411 ICC and 10,148 control patients participated. Variables were costs, return on investment (ROI), iterative Patient Health Questionnaire (PHQ)9 scores, and satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Having one or more of 21 chronic conditions, including those with depression and multiple chronic comorbidities.

Exclusion Criteria:

* Presence of Major Cancer, HIV, or ESRD in either the baseline or measurement periods
* Claims in excess of $100,000 in either baseline or intervention period.
* Claims for long term care or hospice in either baseline or intervention period.
A Sleep Lab Trial to Investigate the Efficacy and Safety of Transdermal Rotigotine in Subjects With Idiopathic Restless Legs Syndrome

The objective of this trial is to demonstrate that rotigotine (SPM 936) is effective in subjects with idiopathic RLS based on the PLMI (Periodic Limb Movements Index)(PLMs/total time in bed) as measured by polysomnography (PSG). The primary variable is the reduction of PLMI at the end of the Maintenance Period compared to Baseline. PLMI data will be obtained from PSGs.


Eligibility Criteria:
Inclusion Criteria:

* Idiopathic RLS

Exclusion Criteria:

* secondary RLS
* history of sleep disturbances
* symptomatic orthostatic hypotension
Surgical Recovery After Left Lateral Hepatic Sectionectomy: Laparoscopic Versus Open Surgery.

The ORANGE II trial is a double blinded randomised controlled trial that will provide evidence on the merits of laparoscopic surgery in patients undergoing a left lateral hepatic sectionectomy in terms of time to functional recovery, hospital length of stay, quality of life, readmission percentage, morbidity and mortality, hospital costs, body image and cosmesis, and long term incidence of incisional hernias.

Recent developments in liver surgery include the introduction of laparoscopic surgery and enhanced recovery programmes. Laparoscopic surgery and enhanced recovery programmes both focus on faster recovery and consequently shorter hospital length of stay.

The ORANGE-II trial is a prospective randomised controlled parallel group superiority trial with a double-blinded experimental and a prospective registry design to determine whether laparoscopic surgery is to be preferred over open surgery in patients undergoing a left lateral hepatic sectionectomy within an enhanced recovery programme. The experimental design produces two randomised arms; (a) open LLS and (b) laparoscopic LLS. An additional registry arm will be based on surgeons/patients that do not want to be randomised because they have an explicit preference for either the laparoscopic LLS or for the open LLS (c).

The primary endpoint of the ORANGE II trial is time to functional recovery. The functional recovery criteria consist of adequate pain control with oral analgetics only, mobility restored to an independent level, absence of intravenous fluid administration, ability to eat solid foods and finally a normal or decreasing serum bilirubin level. A patient is fully functionally recovered when all of the five criteria are satisfied.

Secondary endpoints of this trial are postoperative length of hospital stay, readmission percentage, (liver specific) morbidity, quality of life, body image and cosmetic result, hospital and societal costs during one year and long-term incidence of incisional hernias.

The ORANGE-II trial is a randomised controlled multicentre trial that will provide evidence on the merits of laparoscopic surgery in patients undergoing a left lateral hepatic sectionectomy and participating in an enhanced recovery programme.

Eligibility Criteria:
Inclusion Criteria:

* Patients suitable for undergoing both laparoscopic left lateral sectionectomy as well as open left lateral sectionectomy of the liver.
* Able to understand the nature of the study and what will be required of them.
* Men and non-pregnant, non-lactating women between age 18-80.
* BMI between 18-35.
* Patients with ASA I-II-III

Exclusion Criteria:

* Inability to give written informed consent.
* Patients undergoing liver resection other than left lateral hepatic sectionectomy.
* Patients with ASA IV-V
* Underlying liver disease