cyrilzakka/clinical-trials huggingface dataset:
Safety and Effectiveness of Spiriva in COPD (Chronic Obstructive Pulmonary Disease) Patients Under the Real Condition of Usual Practice

The purpose of this study is to monitor the change in the health status of severe COPD patients after the initiation of Tiotropium therapy. This will be assessed by the physician's global evaluation of the patient's health status on a 8-point scale. This measure has been shown to correlate with a established standard measure of the patients health related quality of life. The primary analysis in this trial will only include patients not pre-treated with a long-acting beta-agonist to establish a clear efficacy signal in this patient population. As the reality of COPD treatment nowadays is poly-pharmacy, a secondary analysis will analyse patients who are pretreated with long-acting bronchodilators to put the changes in the health status in a likely real world context. In parallel to these evaluations of the health status, the lung function response of the patients will be assessed to gain an established objective measure of treatment response.


Eligibility Criteria:
Inclusion criteria:

1. Patients with confirmed diagnosis of COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD; updated 2005).
2. Patients who are assessed to benefit from the intake of long-acting anticholinergics as a monotherapy or as add-on medication.
3. Tiotropium bromide naïve patients.
4. Patients with indication for tiotropium bromide according to Taiwanese Spiriva® label.

Exclusion criteria:

1. Patients with contraindications to tiotropium bromide use (as per the Spiriva® package insert).
2. Known hypersensitivity to the active ingredient or to any of the excipients of Spiriva®.
German Inclisiran Network: Retrospective Registry of Patients Being Treated With the siRNA Inclisiran in Germany

The German Inclisiran Network is a registry of patients with hypercholesterinemia on treatment with the siRNA inclisiran in Germany

The aim of this retrospective, multi-center analysis is to use individual patient data to determine the extent of the variability in LDL-C reduction in response to inclisiran administration in a real-world setting.

Eligibility Criteria:
Inclusion Criteria:

* patients with elevated LDL-C levels (hypercholesterolemia) on stable lipid-lowering drugs for at least one month prior to the application of the siRNA Inclisiran
* patients 18 years and older

Exclusion Criteria:

- patients who do not qualify for treatment with the siRNA inclisiran according to the G-BA (Gemeinsamer Bundesausschuß) in Germany.
Pharmacokinetics of Lisdexamfetamine (Vyvanse®) in Post-bariatric Surgery Patients

This study is being conducted to evaluate how the body absorbs and processes the medication lisdexamfetamine (Vyvanse®). Subjects who are 9-15 months post gastric bypass surgery will be invited to participate. Non-surgical controls will also be enrolled based on a matching criteria to post gastric bypass subjects. Participants will be asked to complete one 12-hour study day and complete one 24-hour post dosing blood draw.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects.
2. Between the ages of 18 and 60 years at the time of informed consent. \*The upper age limit of 60 has been chosen as this medication carries some cardiovascular risk along with the fact that pharmacokinetics in elderly patients vary and may affect the homogeneity of the study.
3. Must be in good health as determined by physical exam, EKG, and medical history.

4a. Underwent RYGB 9-15 months prior (n=10 study completers) -or-

4b. Have not received bariatric surgery and are matched to the RYGB participants by BMI, age and sex (n= 10 study completers)

5. Women of child bearing potential must be practicing a medically acceptable method of birth control and have a negative pregnancy test at baseline.

6. No contraindications to receiving lisdexamfetamine in a single dose of 50 mg.

Exclusion Criteria:

1. Allergy to lisdexamfetamine or any of its constituents.
2. Candidates who are pregnant or nursing.
3. Candidates currently receiving a medication that interacts with lisdexamfetamine, including concurrent use of a stimulant.
4. Subjects who smoke or used any nicotine products in the last six months.
5. Subjects who have a positive urine drug screen for drugs of abuse.
6. Candidates that for any reason cannot comply with the requirements of the study procedures.
7. Candidates experiencing clinically significant or unstable neurological, hepatic, renal or cardiovascular disease on laboratory or baseline EKG screening or any medical disorder that would put the participant at increased risk in the judgement of the investigator or physician.
8. Candidates currently or with a past history of meeting diagnostic criteria for schizophrenia, schizoaffective disorder, bipolar disorder, or other psychotic illness.
9. Candidates with any history of drug abuse or dependence.
10. Candidates with any history of alcohol dependence, or current usage that puts the candidate at risk in the judgement of the investigator or study physician.
11. Candidates who have participated in an investigational drug study in the past 30 days.
12. Significant iron deficient anemia that may impact the pharmacokinetics of lisdexamfetamine.
13. Participant with a significantly and persistently elevated resting blood pressure (\>140/90 mmHg) or pulse (\>100 bpm) after repeated measurement.
Acute Sleep Loss and Arterial Stiffness

The overarching goal of this study is to mimic a night shift work like schedule and characterize circadian variation in Pulse Wave Velocity (PWV), a measure of arterial stiffness, and determine the impact of acute loss of sleep like that experienced by shift workers on PWV.

Night shift work is associated with increased risk of cardiovascular disease (CVD). Pulse wave velocity (PWV) is a commonly used non-invasive measure of arterial stiffness and is strongly associated with CVD. Previous research links sleep loss, like that experienced by shift workers, to elevated levels or abnormal levels of PWV. In addition, there is some research that shows circadian variation in PWV, which has implications for future studies and when PWV should be assessed. The overarching goal of this study is to characterize circadian variation in PWV and determine the impact of acute loss of sleep on PWV during a schedule like that experienced by night shift workers.

Eligibility Criteria:
Inclusion Criteria:

An individual may be eligible to participate if they meet the following criteria:

1. are between the ages of 20 and 29 years;
2. have not been diagnosed or told by a healthcare clinician that they have a medical condition that may impact their blood pressure or cardiovascular health/system;
3. can abstain from smoking tobacco or chewing tobacco products;
4. can abstain from caffeine and exercise for 4 days in a row;
5. are not prescribed medications or take over the counter medications that may impact blood pressure or heart rate (a team physician will review any reported medications identified during screening);
6. do not have a physical condition that may interfere with using the upper arm, upper thigh, or access to the neck area for purposes of performing non-invasive measures linked to this protocol; and
7. feel that they can avoid working and complete the 4 day protocol without interruption.

Exclusion Criteria:

An individual will be excluded if they report:

1. a medical condition or diagnosis that may impact their blood pressure or heart rate;
2. taking any standing medications or prescriptions, other than over the counter medications or contraceptives, that may impact their blood pressure or heart rate;
3. are unable to adhere to a strict 4 day protocol that involves abstaining from caffeine, alcohol, tobacco products (nicotine), and exercise;
4. have a physical condition that may limit use of the upper arm or upper thigh or area around the neck, which is necessary for performing multiple non-invasive measures associated with this protocol.
5. being pregnant.

Because participants may awaken during the in-lab sleep opportunity when staff use the Sphygmocor device, it is important that staff and the study team know if the participant has ever experienced the following:

A\] Sleep Paralysis; B\] Night Terrors; C\] Have Obstructive Sleep Apnea which requires the use of a CPAP Device; D\] Become angry towards others when abruptly woken up; E\] Become physical towards others when abruptly woken up.
A Study of LY2835219 in Healthy Participants

The aim of this two-period study is to compare how much of the study drug gets into the blood stream when it is given as a single oral dose and when it is given as a single oral dose in combination with rifampin (a Food and Drug Administration \[FDA\] approved antibiotic that is used to treat tuberculosis, a bacterial infection that mainly affects the lungs, and other infections). Each participant will complete both study periods.

The study will last about 34 days. Screening is required within 28 days before study drug is given.


Eligibility Criteria:
Inclusion Criteria:

* Overtly healthy sterile males or surgically sterile females or postmenopausal females
* Have a body mass index (BMI) of 18 to 32 kilogram per meter square (kg/m\^2)

Exclusion Criteria:

* Have participated in a clinical trial involving investigational product within the last 30 days
* Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
* Have an abnormal blood pressure
* Show evidence of human immunodeficiency virus (HIV), hepatitis B or hepatitis C
* Have donated blood of more than 500 milliliters (mL) within the last month
* Have used or intend to use over-the-counter or prescription medication including herbal medications within 7 days prior to dosing or during the study
Continuous Measurement of Intratracheal Pressure

Continuous measurement of intratracheal pressure in mechanically ventilated infants using a fibreoptic pressure transducer in the endotracheal tube (ETT). Based on the findings, tracheal pressure can continuously be monitored in the presence of pediatric ETTs by combining ETT coefficients and the flow and airway pressure continuously measured at the proximal end of the ETT.


Eligibility Criteria:
Inclusion Criteria:

* Children \< 10 Years
* volume-controlled ventilation

Exclusion Criteria:

* refusal of written informed consent
* severe pulmonary diseases
Quality of Life in Children With Psychiatric Disorders and Parental Well-being: Effects of Group CBT

This study examines the immediate and long-term effectiveness of a group cognitive behavioral therapy intervention (GCBT) in improving health-related quality of life (HRQOL) in children treated for mixed psychiatric disorders in naturalistic child psychiatric outpatient settings. The effects of a treatment-as-usual condition (TAU) is also examined. Further, the study aims to explore the associations among children´s HRQOL dimensions and parental well-being, and how GCBT may influence these associations.

The effectiveness of GCBT and TAU at the different time points are measured using nonparametric tests, such as Friedman tests and Wilcoxon tests. The associations among children´s HRQOL dimensions and parental well-being variables at different time points are explored using a network analysis approach.

Eligibility Criteria:
Inclusion Criteria:

* child psychiatric outpatient care
* sufficient skills to participate in group sessions

Exclusion Criteria:

* child psychiatric inpatient care
* acute suicidality
* excessive physical aggression
Ganitumab in Locally Advanced Unresectable Adenocarcinoma of the Pancreas

This study is a phase 2, multicenter, randomized, double-blind, active placebo-controlled trial of AMG 479 or placebo in combination with gemcitabine as first-line therapy for locally advanced unresectable adenocarinoma of the pancreas. Approximately 150 subjects will be randomized in a 1:1 ratio to AMG 479 and gemcitabine, or gemcitabine and placebo. Randomization will be stratified by ECOG (0 or 1).

Gemcitabine will be given on days 1, 8, and 15, followed by AMG 479 on days 1 and 15 of every 28 day cycle. Treatment will continue until radiographic disease progression, unacceptable toxicity, withdrawal of consent, or start of a new anti-cancer therapy.

This study is a phase 2, multicenter, randomized, double-blind, active placebo-controlled trial of AMG 479 or placebo in combination with gemcitabine as first-line therapy for locally advanced unresectable adenocarinoma of the pancreas. Approximately 150 subjects will be randomized in a 1:1 ratio to AMG 479 and gemcitabine, or gemcitabine and placebo. Randomization will be stratified by ECOG (0 or 1).

Gemcitabine will be given on days 1, 8, and 15, followed by AMG 479 on days 1 and 15 of every 28 day cycle. Treatment will continue until radiographic disease progression, unacceptable toxicity, withdrawal of consent, or start of a new anti-cancer therapy.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must have histologically or cytologically confirmed locally advanced adenocarcinoma of the pancreas that is unresectable, per institutional practice
* Radiologically measurable and/or non-measurable disease as defined by RECIST version 1.1
* Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
* Men or women \>/= 18 years of age
* Adequate organ function

Exclusion Criteria:

* Early (stage I) or metastatic (stage IV) disease
* Islet cell, acinar cell carcinoma, non-adenocarcinoma, (eg, lymphoma, sarcoma, etc), adenocarcinoma originating from biliary tree or cystadenocarcinoma
* External biliary drain
* Currently treated or previously treated with biologic, small molecule, immunotherapy, chemotherapy (ie, including gemcitabine), or other agents for pancreatic cancer
* Currently treated or previously treated with radiotherapy, or chemoradiotherapy for pancreatic cancer
Attentional Focus in Virtual Reality

The goal of this explorative observational study is to learn about the effect of internal and external focus on postural control in virtual reality and compare with the real world environment in young adults. The main question it aims to answer is:

Does attentional focus effect differently on postural control in virtual reality comparing to real world environment?

Virtual Reality is used to improve postural control in various populations. However, exercise with virtual reality glasses cause new challenges to the user in maintaining balance. In this study, the effect of internal and external focus on postural control in the virtual reality environment will be revealed and compared with the performance in the real environment. The results of the study will guide the customization and optimization of balance training programs implemented in the virtual reality environment. A total of 38 healthy young adults will be included and allocated into Group I (Virtual Reality) or Group II (Real World) (ratio 1:1). The balance performance of the participants will be assessed with single leg stance test and bipodal stance test. The participants will be instructed to stand still and maintain balance on the forceplate in three conditions: (1) with an internal focus, (2) with an external focus, and (3) non-directional. Conditions will be applied to the participants randomly to avoid bias. Each condition will be measured three times and the mean values will be recorded as outcomes. The total displacement of center of pressure (CoP), the mean velocity of CoP, the CoP area, total mediolateral (ML) displacement, the mean velocity in ML, total anteroposterior (AP) displacement and the mean velocity in AP will assessed with K-Force Plates (Kinvent, France).

Eligibility Criteria:
Inclusion Criteria:

* Being a healthy individual between the ages of 18-26
* Lower extremity functional motor signs or sensory features should be normal or corrected
* No lower extremity injury within 6 months
* Not taking alcohol or medication 12 hours before
* Having no virtual reality experience

Exclusion Criteria:

* History of epilepsy, marked dissociative seizures
* Needing assistive devices to maintain upright posture
* Other comorbidities that may affect postural control (dizziness, vestibular disorders, orthopedic or cardiovascular comorbidities)
* Being an athlete
* Positive Fukuda stepping test
Registry Experience at the Washington Hospital Center, Des - Taxus Liberte Versus Xience V

Multicenter, retrospective registry to collect 9-12 month follow-up data to evaluate major adverse cardiac events in patients whom have undergone percutaneous coronary intervention and received either Taxus Liberte or Xience V.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age or older, both genders
* Underwent PCI with Taxus Liberte (alone) or Xience (alone)

Exclusion Criteria:

* Underwent PCI with a non-Taxus Liberte or Xience V DES during the same procedure
* Received both Taxus-Liberte and Xience-V during the same index procedure
* Patients not taking, or unable to take, dual antiplatelet therapy (aspirin plus clopidogrel or prasugrel).
The Role of the Upper Colliculus in the Idiopathic Blepharospasm

This pilot study aims at investigating the role of superior colliculus in patients with idiopathic blepharospasm (BSP) de novo, compared to healthy subjects.

The objective of the study is to investigate the function of the superior colliculus (SC) related to visual stimulation by means of fMRI (functional magnetic resonance imaging) in patients with idiopathic BSP compared to healthy subjects. The hypothesis is that SC function is impaired in BSP (role of biomarker of SC).

Eligibility Criteria:
Inclusion Criteria:

* Non treated idiopathic blepharospasm
* Age: 30- 70 years

Exclusion Criteria:

* Under the following treatments: Botulin toxin, anticholinergic, benzodiazepines, baclofen, beta- and alpha-blockers collyrium
* No MRI Contraindication
Pediatric Diabetics Type 1 Using InsuPatch

This study is a prospective, single-center, open label, randomized; two-arms cross over study.

This is the test protocol for the InsuPatch device, whose purpose is to improve insulin delivery into the blood when the insulin is infused using an insulin-infusion pump by controlled heating of the area surrounding the point of infusion.

Twenty(20) type 1 children with Type 1 Diabetics Mellitus (TIDM) who are meeting the inclusion/exclusion criteria as outlined below and who provide written Informed Consent will be enrolled in the study.

The study will consist of an outpatient enrollment visit and two admissions(One clamps with the InsuPatch and one clamp without the InsuPatch) . Each Subject will thus serve as his/her own control.

Eligibility Criteria:
Inclusion Criteria:

1. Age 12-17 (inclusive)
2. Clinical diagnosis of T1DM at least one year's duration
3. On CSII therapy for at least three months
4. Hemoglobin A1c(HBA1C) values below 10% and above 6.5%
5. Minimum weight requirements of at least 37.9 Kg.
6. Ability to comprehend written and spoken English
7. Body Mass Index z-score below 90%

Exclusion Criteria:

1. Celiac disease, gastroparesis, or other gastrointestinal disorder associated with alerted carbohydrate absorption or intestinal motility.
2. Medication besides insulin known to alter blood glucose, gastric motility, or intestinal carbohydrate absorption
3. Female subjects of reproductive potential who are pregnant or breast feeding
4. Inability to comprehend written and spoken English
5. Any other condition, which in the judgment of the investigators, would interfere with the subject's or parents' ability to provide informed consent or the investigator's ability to perform the study.
6. Hematocrit below 35 or serum potassium below 3.4 (confirmed by two samples)
IGF-1, Sarcopenia and Mortality: a Cohort Study in Patient With Cognitive Impairment

Insulin-like growth factor 1 (IGF)-1 is an important neuromyotrophic hormone. Disregulation of this hormone has been reported to influence the genesis of cognitive impairment and dementia in the elderly patients. We analyzed the possible link between IGF-1 and risk of Sarcopenia and Mortality in a cohort of elder patients with cognitive impairment.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cognitive impairment (MMSE \< 24)
* Age \> 65 ys

Exclusion Criteria:

* Diagnosis of pancreatic disorders
* Diagnosis of acromegaly
* Diagnosis of GH-related disorders
* Recent bone fractures or immobility before the enrollment (3 months)
* Cancer
Incidence of Acute Cerebrovascular Events Using Either Minimized or Standard Cardiopulmonary Bypass Circuit

The prospective, randomized, two centre study investigates acute cerebrovascular events during extracorporal circulation and the early post operative outcome when using either the minimized cardiopulmonary bypass circuit (ROCsafeTM) or a standard cardiopulmonary bypass circuit in patients undergoing coronary artery bypass grafting.

Coronary artery bypass grafting with extracorporal circulation is established as the golden standard. The conventional cardiopulmonary bypass (CPB) system is associated with inflammatory reaction, hemolysis, hemodilution an disturbances of the blood coagulation system. Also it's well known that neurological disturbances caused by embolic material and air bubbles are potential risks of CPB. The new minimized perfusion circuit ROCsafeTM is a closed, reservoir-less, reduced prime, surface coated circuit, with optimized safety features in effectively eliminate both macro and micro air bubbles and should optimize the clinical outcome after CABG using cardiopulmonary bypass.

Eligibility Criteria:
Inclusion Criteria:

* Patient is older than 17 years
* Patient is acceptable candidate for CABG operation
* Patient or the patient's legal representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent.

Exclusion Criteria:

* Ejection fraction less than 30 %
* Valve surgery
* Acute endocarditis or history of endocarditis
* Cerebral ischemia within 4 weeks before surgery
* Detection of intracardial thrombi in preoperative echocardiography
* Stenosis of A. carotis int. greater than 70 %
* Patients older than 80 years
* Patients on dialysis
* Acute myocardial ischemia or infarction within two weeks before inclusion
* Markedly elevated baseline C-reactive protein (CRP) or leucocytosis
* Cancer or immunologic diseases
* Dysregulation of the coagulation cascade (not concerning INR or PTT under cumarin or heparin treatment)
* Intake of steroids or NSAR
* Female of childbearing potential
* Participation in an other study
* Contraindication for MRI (e.g. pacemaker, any kind of implanted metal)
* Claustrophobia