cyrilzakka/clinical-trials huggingface dataset:
NanoCross BTK, a Prospective, Non-randomized, Multicenter, Controlled Trial Evaluating the Performance of the NanoCrossTM .014 Balloon Catheter in Infrapopliteal Lesions

The objective of this clinical evaluation is to evaluate the immediate and long-term (up to 12 months) outcome of NanoCrossTM balloon catheter (Covidien) in a prospective, non-randomised, controlled investigation for the treatment of patients with critical limb ischemia (Rutherford 4-5) due to the presence of lesions of minimally 10cm in length at the level of the below-the-knee arteries.


Eligibility Criteria:
Inclusion Criteria:

* Patient presenting with rest pain or minor tissue loss (Rutherford class 4 or 5)
* Patient is willing to comply with specified follow-up evaluations at the specified times
* Patient is \>18 years old
* Patient understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
* Patient has a projected life-expectancy of at least 12 months
* Patient is eligible for treatment with the NanoCrossTM .014 balloon catheter (Covidien)
* Male, infertile female, or female of child bearing potential practicing an acceptable method of birth control with a negative pregnancy test within 7 days prior to study procedure
* De novo lesion or restenotic lesion after PTA in the infrapopliteal arteries,suitable for endovascular therapy
* Total target lesion length minimally 100mm
* Target vessel diameter visually estimated to be \>1.5mm and \<4.0mm
* Guidewire and delivery system successfully traversed lesion
* At least one non-occluded crural artery with angiographically documented run- off to the foot.

Exclusion Criteria:

* Patient refusing treatment
* The reference segment diameter is not suitable for the available balloon design
* Untreated flow-limiting inflow lesions
* Perioperative unsuccessful ipsilateral percutaneous vascular procedure to treat inflow disease just prior to enrollment
* Any previous surgery in the target vessel (including prior ipsilateral crural bypass)
* Aneurysm in the target vessel
* Target lesion has severe calcification as determined by physician's discretion
* Non-atherosclerotic disease resulting in occlusion (e.g. embolism, Buerger's disease, vasculitis)
* Severe medical comorbidities (untreated CAD/CHF, severe COPD, metastatic malignancy, dementia, etc) or other medical condition that would preclude compliance with the study protocol or 1-year life expectancy
* Major distal amputation (above the transmetatarsal) in the study limb or non- study limb
* Septicemia or bacteremia
* Any previously known coagulation disorder, including hypercoagulability
* Contraindication to anticoagulation or antiplatelet therapy
* Known allergy to contrast media that cannot be adequately pre-medicated prior to the study procedure
* Patient with known hypersensitivity to heparin, including those patients who have had a previous incidence of heparin-induced thrombocytopenia (HIT) type II
* Currently participating in another clinical research trial
* Angiographic evidence of intra-arterial thrombus or atheroembolism from inflow treatment
* Target lesion access not performed by transfemoral approach.
The Influence of Head and Neck Position on Performance of Ambu AuraGain™

The influence of different head and neck positions on the effectiveness of ventilation with the Ambu AuraGain airway remains unevaluated.

This study aimed to evaluate the influence of different head and neck positions on ventilation with the AuraGain airway.

AuraGain will be placed in all patients, and mechanical ventilation will be performed using a volume-controlled mode with a tidal volume of 10 ml/kg.

The expiratory tidal volume, peak inspiratory pressure, oropharyngeal leak pressure, and ventilation score will be assessed first for the neutral head position and then for the extended, flexed, and rotated head positions in a random order.

Fiberoptic bronchoscopic view will be also assessed for each head and neck positions.


Eligibility Criteria:
Inclusion Criteria:

* Adults who were to undergo elective surgery under general anaesthesia using supraglottic airway device

Exclusion Criteria:

* Patients who had risk factor for difficult intubation
* BMI \> 30kg/m2
* Emergency operation without NPO
* History of cervical spine surgery or disease
* History of esophageal operation or gastroesophageal reflux disease
Fully Covered Self-expandable Metal Stents (FCMS) in Benign Biliary Strictures

Endoscopic treatment of benign biliary strictures can be challenging. Balloon dilation and/or plastic stent placement are currently the most popular techniques. Partially covered self-expandable metallic stents have also shown to be effective but can be difficult to remove. A novel fully covered metallic stent has recently been developed.

The aim of this study was to prospectively evaluate the placement of fully covered self-expandable metallic stents (FCSEMS) in this setting.

After inclusion, an endoscopic procedure (ERCP) was performed in all patients in order to place a FCMS across the benign biliary stricture. The FCMS was left in place for 6 months and then extracted during a second ERCP procedure. An opacification was performed to assess the efficacy of stenting. Patients were followed up during one year after FCMS extraction.

Eligibility Criteria:
Inclusion Criteria:

* a history of liver transplantation, chronic pancreatitis or biliary surgery
* impairment of liver function tests such as elevated liver enzymes and/or cholestasis
* a biliary stricture associated with ductal dilation detected by US, CT or MRI, with a minimum distance of 2cm between the upper stricture's edge and the lower limit of the main biliary confluence or liver hilum .

Exclusion Criteria:

* an uncertainty about the benign nature of the stricture
* an intra-hepatic cholangitis and/ or a stricture extending beyond the hilum
Assessing the Accuracy of the A&D TM-2657W Oscillometric Device

The A\&D automatic blood pressure device is a new kiosk that can measure blood pressure in the general population.

The investigators plan to use the existing International Standards Organization validation protocol to determine whether this device measures blood pressure accurately.

Methods and Analysis

Study methodology will follow the ISO protocol:

* 85 adult (age 18 years or greater) subjects will be included (it is estimated that approximately 140 subjects will need to be screened as some will be ineligible). 85 is the recommended sample size for validation studies using the ISO protocol.
* Subjects will be recruited via an existing registry of over 250 individuals that have participated in past measurement studies, through advertisements, and from the University of Alberta Hypertension Clinic.
* Specific requirements for a certain percentage of subjects with specific age, sex, upper arm circumference, and baseline blood pressure levels will be observed to ensure that a representative sample is studied (according to the ISO standards).
* Subjects that are pregnant or with atrial fibrillation will be excluded. Blood pressure measurements will be taken using recommended, optimal technique.
* Nine measurements will be taken in each subject, alternating between blinded two-observer auscultation with a mercury-based sphygmomanometer (the reference standard) and the TM-2657. Careful attention will be paid to ensuring proper cuffing. The first two measurements will be discarded and the latter seven measurements (4 auscultatory and TM-2657 measurements) will be used in the analysis, which will be conducted according to ISO standards.
* Accuracy will be assessed according to Criterion 1 and 2 of the ISO standard. Bland-Altman plots will be generated. A plot of measurement error versus arm circumference will be generated as well.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* normal sinus rhythm
* have capacity to give consent
* following the International Standards Organization criteria for: gender distribution, limb size, blood pressure distribution

Exclusion Criteria:

* atrial fibrillation
* pregnancy
Study of Efficacy and Safety of Inclisiran in Japanese Participants With High Cardiovascular Risk and Elevated LDL-C

This was a placebo-controlled, double-blind, randomized trial in Japanese participants with history of coronary artery disease (CAD) or participants categorized in 'high risk' by JAS 2017 guideline, or Japanese participants with heterozygous familial hypercholesterolemia (HeFH) and elevated Low-density lipoprotein cholesterol (LDL-C) despite maximum tolerated dose of statin(s) to evaluate the efficacy, safety, tolerability, and PK of subcutaneous inclisiran injection(s).

The expected duration of the participants' involvement in the study was approximately 374 days which included screening (up to 14 days), Day 1 study drug administration, two additional injections on Day 90 and Day 270, and the follow-up period to Day 360.

The primary analysis was conducted after all participants had finished Day 180 visit assessments or discontinued before Day 180 visit.

After the primary analysis, double-blind treatment period were maintained to Day 360, although specific sponsor members (except for blinded monitors) were unblinded for the regulatory submission in Japan.

Eligibility Criteria:
Inclusion Criteria:

* Participants with history of CAD or participants categorized in 'high risk' by Japan Atherosclerosis Society (JAS) 2017 guidelines or participants with heterozygous familial hypercholesterolemia (HeFH)
* As per the JAS 2017 guideline, participants not meeting the LDL-C management targets.
* Participants on statins should be receiving a maximally tolerated dose.
* Participants not receiving statins must have documented evidence of intolerance to at least one statin.
* The lipid-lowering therapy should have remained stable for ≥ 30 days before screening with no planned medication/ dose change until Day 180

Exclusion Criteria:

* Participants diagnosed with homozygous familial hypercholesterolemia (HoFH).
* Treatment (within 90 days of screening) with monoclonal antibodies directed towards PCSK9.
* New York Heart Association (NYHA) class IV heart failure or last known left ventricular ejection fraction \<25%.
* Cardiac arrhythmia within 3 months prior to randomization that is not controlled by medication or via ablation.
* Uncontrolled hypertension: systolic blood pressure \>160 mmHg or diastolic blood pressure \>100 mmHg prior to randomization despite antihypertensive therapy.
* Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver or unexplained elevations in alanine aminotransferase (ALT), aspartate aminotransferase (AST), \>3x the upper limit of normal (ULN), or total bilirubin \>2x ULN at screening.
* Severe concomitant non-cardiovascular disease that carries the risk of reducing life expectancy to less than 2 years.
Individual Patient Expanded Access for AB-SA01, an Investigational Anti-Staphylococcus Aureus Bacteriophage Therapeutic

The purpose of the expanded access program is to allow physicians to provide treatment with investigational drug, AB-SA01, for patients with serious or immediately life-threatening Staphylococcus aureus infections, for which no alternative treatment(s) are currently available, and who meet the criteria for treatment under FDA's Expanded Access regulations and criteria set forth by AmpliPhi Biosciences Corporation.

To be considered for expanded access, the request should be submitted to AmpliPhi by a qualified and licensed physician with expertise and facilities appropriate for the administration of the investigational medicine. Treating physicians should contact AmpliPhi by emailing expandedaccess@ampliphibio.com with "Expanded Access Request" in the subject line, and include in the email the treating physicians name, organization/hospital/institution, physical address, email address, telephone number, and a brief description of the indication/condition.

Any approval of expanded access to investigational medicine must always comply with the applicable laws and regulations.


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

-
Relative Bioavailability of Two Different Batches of a Linagliptin / Metformin Combination Tablet in Healthy Volunteers

The objective of the current study is to investigate the relative bioavailability of two different batches of a 2.5 mg linagliptin / 1000 mg metformin fixed dose combination tablet (FDC).


Eligibility Criteria:
Inclusion criteria:

1. Healthy males and females according to the following criteria: Based upon a complete medical history, including physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests
2. Age 21 to 50 years (incl.)
3. Body Mass Index (BMI) 18.5 to 29.9 kg/m2 (incl.)
4. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation

Exclusion criteria:

1. Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
2. Any evidence of a clinically relevant concomitant disease
3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
4. Surgery of the gastrointestinal tract (except appendectomy)
5. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
6. History of relevant orthostatic hypotension, fainting spells or blackouts
7. Chronic or relevant acute infections
8. History of relevant allergy or hypersensitivity (including allergy to drug or its excipients)
9. Intake of drugs within one month or less than 10 half-lives of the respective drug prior to first study drug administration
10. Participation in another trial with an investigational drug within 2 months prior to administration or during the trial
11. Smoker (more than 10 cigarettes or 3 cigars 3 pipes daily)
12. Alcohol abuse (average consumption of more than 20 g/day in females and 30 g/day in males)
13. Drug abuse
14. Blood donation (more than 100 mL within four weeks prior to day 1 of visit 2)
15. Any laboratory value outside the reference range that is of clinical relevance
16. Inability to comply with dietary regimen of trial site

    For female subjects of childbearing potential only:
17. Positive pregnancy test, pregnancy or planning to become pregnant 1 month before study or within 2 months after study completion
18. No adequate contraception 1 month before study and until 2 month after study completion, e.g. not any of the following: implants, injectables, combined hormonal contraceptives, hormonal IUD (intrauterine device), sexual abstinence for at least 1 month prior to first study drug administration, vasectomised partner (vasectomy performed at least 1 year prior to enrolment), or surgical sterilisation (including hysterectomy). Females, who do not have a vasectomised partner, are not sexually abstinent or surgically sterile will be asked to use an additional barrier method (e.g. condom).
19. Lactation
Cancer Related Cognitive Impairment After Chemotherapy: Evaluation of Potential Therapeutic Interventions

Background: Mindfulness has been applied to improve after cancer care by enhancing psychological well-being; however, little is known about its impact on cognitive impairment experienced by cancer patients after chemotherapy. Mindfulness may be relevant in tackling cognitive impairment by decreasing emotional distress and fatigue, by decreasing inflammation, and by strengthening brain functional connectivity. The aim of the present study protocol is to evaluate the efficacy and mechanisms of a mindfulness-based intervention to reduce cognitive impairment in breast-cancer patients after chemotherapy.

Methods: The present study is a three-group randomized controlled trial with assessments at baseline, one-three weeks after the intervention and at three months follow-up. One hundred twenty breast cancer patients who ended treatment minimum 6 months and maximum 5 years before and who have cognitive complaints will be enrolled. They will be randomized into one of the following three study arms: (1) a mindfulness-based intervention group (n=40), (2) an active control condition based on physical training (n=40), or (3) a waitlist control group (n=40). Both the mindfulness-based intervention and the active control condition exist of four group sessions (3 hours for the mindfulness condition and 2 hours for the physical training) spread over 8 weeks. The primary outcomes will be cognitive complaints as measured by the cognitive failure questionnaire and changes in brain functional connectivity in the attention network. Secondary outcomes will be (1) levels of emotional distress, fatigue, mindfulness; (2) neurocognitive tests; (3) structural and functional brain changes using MR imaging, and (4) inflammation.

Discussion: The study will examine the impact of a mindfulness-based intervention on cognitive impairment in breast-cancer patients. If the findings of this study confirm the effectiveness of a mindfulness-based program to reduce cognitive impairment, it will be possible to improve quality of life for ex-cancer patients. We will inform health care providers about the potential use of a mindfulness-based intervention as a non-pharmaceutical, low-threshold mental health intervention to improve cognitive impairment after cancer.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of breast cancer at an early stage with or without solitary metastases (except solitary brain metastases)
* completed treatment (surgery and chemotherapy) minimum 6 months and maximum 5 years before
* significant cognitive complaints as measured by the Cognitive Failure questionnaire (CFQ total score \> mean study Ponds + 1 SD or on 2 or more of the CFQ extra questions (T/E) \> mean study Ponds + 1 SD; (Ponds, Van Boxtel, \& Jolles, 2006))
* have sufficient understanding of Dutch

Exclusion Criteria:

* a history of mental retardation, psychiatric and or neurological disorder
* previous participation in a mindfulness training
Colloid Osmotic Pressure During Heart Surgery in Children

Clinical oedema is seen after open heart surgery with the use of cardiopulmonary bypass and hypothermia in children. The oedema formation is due to increased fluid transport from blood to tissue. This transcapillary fluid transport is dependent on differences in interstitial and plasma colloid osmotic pressure. The purpose of this investigation is to evaluate changes in interstitial colloid osmotic pressure before, under and after the use of cardiopulmonary bypass in children. The study hypothesis is that oedema developed during cardiopulmonary bypass and hypothermia is caused by increased micro vascular protein leakage and reduced colloid osmotic pressure gradient through the capillary membrane.


Eligibility Criteria:
Inclusion Criteria:

* The diagnosis of a congenital heart defect
* scheduled for open heart surgery with the use of cardiopulmonary bypass
* under 13 year of age
* informed consent obtained from the parents

Exclusion Criteria:

* renal failure
* liver failure
Food Effect Study PF-04136309

The purpose of this study is to evaluate the effect of food intake on PF-04136309 pharmacokinetics (PK) following a single dose at 1000 mg.

The present study will be conducted in healthy adult subjects. The single dose of 1000 mg has been shown to be safe in a previous study in healthy subjects. To evaluate the effect of food on PF-04136309 PK at the dose of 1000 mg, which is the maximum dose that may be evaluated in the multiple dose setting in patients, will provide information to guide the dose administration in regards to food intake at relevant therapeutic dose levels for further studies in patients.

Eligibility Criteria:
Inclusion Criteria:

* Healthy female subjects of non childbearing potential, who at the time of screening are between the ages of 45 55, and/or male subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests).
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Subjects who are smoking, or with evidence of disease, conditions affecting absorption, treatment with other investigational drug within 30 days, history of regular alcohol consumption, use of prescription, nonprescription drugs and dietary supplement within 7 days, or blood donation of 500 mL within 56 days
Comparative Study of QuietCare

The objective of the study is to examine the efficacy and safety of QuietCare in a randomized, open study in elderly subjects living in assisted/ independent living facilities for 6 months.


Eligibility Criteria:
Inclusion Criteria:

1. ability to move independently or by using a walker (without assistance) inside
2. residents using a single room, age 65 or older, of either sex

Exclusion Criteria:

* people who use wheel chairs,
* people who are bed-ridden
Effect of MET on Meralgia Paraesthesia Postpartum "Muscle Energy Technique"

To investigate the effect of muscle energy technique on Femoral meralgia paraesthesia in a postpartum female. BACKGROUND: meralgia paraesthesia is one of the serious disorders in the postpartum female which results in pain and less physical activities.

.........HYPOTHESES:

This study hypothesized that:

muscle energy technique will have a significant effect on Femoral meralgia paraesthesia in postpartum female

Thirty meralgia paraesthesia postpartum females will participate in this study.

The patients will randomly be divided into two equal groups; the control group received the conventional selected exercise program and the study group received the same exercise training program in addition to muscle energy technique, three times per week for four weeks.

The evaluation methods by Femoral nerve conduction velocity will be measured via the Neuropack S1 MEB9004 EMG device before the exercise program and after finishing the exercise program, and also the Pelvic compression test and Pain numeric rating scale

Eligibility Criteria:
Inclusion Criteria:

* Thirty meralgia paraesthesia postpartum female Patients
* with positive Pelvic compression test
* age ranging from 25:40 years
* post vaginal delivery or post-operative (postpartum) persistent dysthesia in anterolateral thigh (one side or both)
* body mass index (20:29.9) Kg/m2

Exclusion Criteria:

* difficulty to communicate or to understand program instructions
* other conditions that caused pain (for example fibromyalgia and arthritis)
* any psychiatric or cognitive symptoms any other musculoskeletal disorders or neurologic diseases of the lower extremities and spine