cyrilzakka/clinical-trials huggingface dataset:
Nitrate, Chronic Obstructive Pulmonary Disease (COPD) and Exercise

Patients with moderate chronic obstructive pulmonary disease (COPD) typically have reduced exercise capacity. This is because their lungs are damaged and because of increased work of breathing. In some patients, exercise capacity is reduced to such a level that even simple activities of daily living, such as washing and dressing, may impose a challenge.

Recent findings in healthy young people suggest that increasing the amount of nitrate in our diet in the form of beetroot juice can improve the ability to exercise. Studies involving cycling have shown that less oxygen is needed to perform the same level of exercise after taking more nitrate in the diet. Nitrate (found in abundance in beetroot) is known to be converted in the body to nitric oxide (NO), a substance which increases blood flow and may affect the energy-producing mechanisms inside muscle cells. A recent exciting finding is that such dietary nitrate supplementation appears to reduce the amount of oxygen needed to complete moderate intensity exercise (walking) in healthy individuals. It is the purpose of this study to see if such effects could be seen in COPD patients. If this is indeed the case, then it may suggest that a period of dietary supplementation of a relatively cheap, widely available, and natural food product may improve the ability of patients to undergo everyday tasks and ultimately improve their quality of life.

To help investigators understand the effects of dietary nitrate supplementation on the ability to exercise in COPD patients, the investigators will recruit 15 people with mild to moderate disease. They will complete a series of undemanding exercise tests on three separate occasions. On one occasion they will have had a course of nitrate rich beetroot juice leading up to the tests, and on the other occasion they will have had a course of beetroot juice with the nitrate removed. The investigators will monitor blood pressure, levels of nitrate and nitrite in the blood, oxygen uptake and functional capacity during the tests which will allow us to assess any effects that may have occurred as a result of increased nitrate intake.


Eligibility Criteria:
Inclusion Criteria:

* Mild-moderate COPD (FEV1 30%-80% predicted values)
* Between the ages of 40-75
* Able to give informed consent

Exclusion Criteria:

* Uncontrolled hypertension (systolic BP\> 160mmHg, diastolic \>100mmHg)
* Regular therapy with organic nitrates, nicorandil and antibiotics.
* Current smoker (Have smoked within the last 3 months)
* Chronic Kidney Disease (stage 4 or worse)
* Any other serious medical condition which would interfere with data interpretation and safety or that may make cycling exercise difficult, limited or uncomfortable.
The Use of rFVIIa in Trauma Patients: A Multi-Center Case Registry

Trauma surgeons throughout the US have begun using recombinant activated factor VII (rFVIIa) to control severe hemorrhage following injury when traditional measures have failed. Despite promising results from several small studies, there remain several unanswered questions regarding the use of this relatively expensive product in injured patients including:

* The timing of administration
* Selection of appropriate patients who are most likely to benefit
* The effective dose in injured patients
* The potential need for repeated dosing
* The need for administration of platelets and correction of acidosis prior to administering the first dose
* The risks associated with the use of rFVIIa including venous and/or arterial thrombosis
* The potential for rFVIIa to cause or aggravate post-injury organ failure and/or infectious complications
* An analysis of cost versus benefit The purpose of this study is to collect a large sample of patients from multiple institutions in order to address the issues listed above. To this end, the Western Trauma Association Foundation is sponsoring a multi-center case registry for patients receiving rFVIIa for treatment of uncontrolled hemorrhage.

This is a prospective, multi-center case registry that seeks to combine the collective experience with the use of rFVIIa at UCSF/SFGH with other trauma centers. The study is being conducted under the auspices of the Western Trauma Association and the American Association of the Surgery of Trauma. Both organizations have a long history of successfully completing multi-center studies. The outcomes to be used in this study are: 1) survival, 2) amount of blood products infused before and after rFVIIa, 3) coagulation factors (PTT, INR) before and after, and 4) the surgeon's assessment of hemostasis. Data will also be analyzed to determine the cost effectiveness of rFVIIa when compared with other methods of treating severe hemorrhage, primarily administration of blood products. Finally, the incidence of complications and thrombotic events after drug administration will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

Coagulopathy treated with rFVIIa

Exclusion Criteria:

none
Comparison of Bronchodilator Treatment Practices in Group E COPD Patients

COPD is a heterogeneous condition caused by airway (bronchitis/bronchiolitis) or alveolar (emphysema) abnormality, changes with chronic respiratory changes (dyspnea, dyspnoea, phlegm). It is characterized by persistent and frequently progressive airway obstruction. In COPD, which progresses with high mortality, non-pharmacological treatments are applied, as well as pharmacological treatments. They have an essential place in slowing down the progressive course of this treatment. However, despite the treatment administered to COPD patients, outdoor weather conditions, improper use of inhaler treatments, or comorbidities may cause acute exacerbation of COPD.

Dry air nebulizer devices use dry air from the central system in hospitals. This system, which converts bronchodilator drugs into nebulizers by creating high currents, works like classical nebulizers without an electrical system and can have a higher flow rate than jet nebulizer devices. This procedure, which can be applied to COPD patients without giving high-flow oxygen, prevents carbon dioxide retention. There is no study in the literature comparing the bronchodilator effectiveness of dry air, classical nebulizer, and jet nebulizer, and the investigators aimed to compare the efficacy of these three treatment modalities in our study.


Eligibility Criteria:
Inclusion Criteria:

* Group E COPD patients

Exclusion Criteria:

* Recent MI
* Pulmonary embolism
* Cerebral aneurysm
* Active hemoptysis
* Pneumothorax
* Nausea, vomiting
* Recent thorax, abdominal, and eye surgery were identified in the patients before the pulmonary function test and were not included in the study.
* Mental retardation
* Pneumonia with acute exacerbation of COPD
* Patients with pulmonary edema due to congestive heart failure
* Patients with interstitial lung disease along with COPD
The Effect of Transcranial Direct Current Stimulation on Visual Attention - Single Sessions

Recently, attention has been drawn to non-invasive brain stimulation techniques, such as transcranial direct current stimulation (tDCS), in order to enhance cognitive functions by modifying brain plasticity and use it in different healthy and diseased populations. In the current research, investigator aim to examine the short-term effects of multiple tDCS protocols in healthy adults population on visual attention and identify the neural underpinnings of tDCS-induced behavioral aftereffects using a combined tDCS/ MRI network-based approach.

Investigator will investigate the shor-term effects of active tDCS as compared to a placebo stimulation on visual attention in the healthy seniors. A cross-over, randomized, placebo-controlled design will be used. Single tDCS sessions will be performed in 4 sessions over distinct brain areas with ongoing visual attention training. During the stimulation, investigator will use the visual matching task. MRI protocol consisting of T1 and resting state fMRI sequences will be acquired before and after every stimulation session in order to search for active vs. placebo tDCS-induced changes in brain activation and resting state functional connectivity and to identify neural correlates of behavioral changes.

Eligibility Criteria:
Inclusion Criteria:

* right handed, healthy volunteers in two groups - healthy adults under 40 years, healthy seniors over 50 years

Exclusion Criteria:

* psychiatric disorders, including major depression, major vascular lesions, and other brain pathologies detected by MRI that might present with cognitive decline

  * a cardio pacemaker or any MRI-incompatible metal in the body
  * epilepsy
  * any diagnosed psychiatric disorder
  * alcohol/drug abuse
  * lack of cooperation
  * presence of cognitive impairment
A Study to Determine the Safety and Efficacy of Once Daily Raltegravir Compared to Twice Daily Raltegravir (MK-0518-071)

A study to evaluate the safety, tolerability and efficacy of once daily Raltegravir compared to twice daily raltegravir when each is given in combination with TRUVADA™ in treatment-naïve human immunodeficiency virus (HIV)-infected patients.

Following the 96-week double-blind study period (MK0518-071)(NCT00745823), subjects may enroll in an extension study (MK0518-071-10)(NCT00745823). From weeks 96 to 120, subjects' treatment assignments will remain as in the base study.

From week 120 to 240, all subjects will receive open-label raltegravir (800 mg, once daily) in combination with TRUVADA™.

Eligibility Criteria:
Inclusion Criteria:

* Patient is male or female 18 years of age or older
* Patient is HIV positive
* Patient is naïve to antiretroviral therapy (ART) or has received less than 7 days total of any ART

Extension Study:

* The planned extension study did not take place as the study was terminated after the Week 48 analysis.

Exclusion Criteria:

* Patient is a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence
* Patient has documented resistance to tenofovir or emtricitabine
* Patient is currently participating or has participated in a study with an investigational compound or device within 45 days of signing informed consent
* Patient is pregnant or breastfeeding, or expecting to conceive
Establishment and Verification of Pancreatic Volume Formula Based on Imaging

This study intends to construct the linear relationship between pancreatic volume and individual attributes (height, weight, width of anterior superior iliac spine, etc.), and to establish and verify the formula of pancreatic volume.

The volume of pancreas in healthy individuals changes with age. The pancreatic volume gradually increases from birth to 20 years old. There is a plateau period from 20 to 60 years old, and the volume gradually decreases after 60 years old. With the development of imaging technology, pancreatic volume can be measured by computer tomography and magnetic resonance imaging.

Whether it is pancreatic atrophy after chronic pancreatitis or pancreatic edema after acute pancreatitis, the pathological changes of pancreatic parenchyma may lead to changes in pancreatic volume. Many studies have confirmed that pancreatic volume can be used to evaluate the course of pancreatic related diseases such as diabetes and acute pancreatitis.

Therefore, the establishment of accurate and convenient pancreatic volume formula can help to estimate the initial pancreatic volume of patients. This study is helpful to evaluate the clinical stage, severity and prognosis of pancreatic related diseases.

Eligibility Criteria:
Inclusion Criteria (Meet 1 or 2 or 3):

* Healthy individuals (excluding pancreatic related diseases, such as acute and chronic pancreatitis, pancreatic trauma, pancreatic tumor, peripancreatic lesions, diabetes and other diseases that may affect the volume of the pancreas);
* Patients with chronic pancreatitis;
* Patients with acute pancreatitis within 144 hours after the onset of typical symptoms (severe persistent epigastric pain).

Exclusion Criteria:

* suspected to have malignant tumors;
* History of pancreas related surgery or minimally invasive treatment (such as pancreaticoduodenectomy, ERCP, etc.);
* acute exacerbation of chronic pancreatitis;
* pregnant or breastfeeding women;
* patients who refused to participate in the study.
A Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Allergic Conjunctivitis

The objective of the study is to evaluate the efficacy and safety of OTX-DP as a dexamethasone ophthalmic insert when placed in the canaliculus of the eyelid for the treatment of the signs and symptoms of allergic conjunctivitis.


Eligibility Criteria:
Inclusion Criteria:

* Has a positive history of ocular allergies and a positive skin test reaction to a perennial allergen and a seasonal allergen
* Has a positive bilateral CAC reaction to a perennial allergen within minutes of instillation

Exclusion Criteria:

* History of refractive surgery (including LASIK procedures) within the past 2 years
* History of retinal detachment, diabetic retinopathy, or active retinal disease
* Presence of an active ocular infection or positive history of an ocular herpetic infection at any visit
* History of IOP increase as a result of steroid treatment
* A female who is currently pregnant, planning a pregnancy, or lactating
The Performance-Perceptual Test as a Counseling Tool

The purpose of the study is to determine whether a new test of ability to understand speech in noise and an associated counseling program can improve hearing aid satisfaction. Participants complete routine hearing tests, some hearing-related questionnaires and the new speech test. One group of participants receives the new form of counseling, the second group does not. Hearing aid satisfaction following 10 weeks hearing aid use is compared across the groups.

Hearing aid dissatisfaction continues to be disappointingly high, even though hearing aid technology has improved dramatically over the last 10 years or so. Unfortunately, the results of most commonly used self-report measures cannot be directly compared with the results from performance measures since the modes of testing are very different. Thus, it is hard for clinicians to reconcile data from individuals reporting more handicap or less hearing aid satisfaction than would be expected from their performance.

In this study, the investigators use a test known as the Performance-Perceptual Test (PPT) to determine whether simple counseling based upon discussion of PPT results can be used to better align perceived and measured ability to understand speech-in-noise; and, more importantly, whether such counseling can decrease reported handicap and improve hearing aid satisfaction.

Hearing aid users complete the PPT for aided and unaided listening, along with standardized questionnaires measuring reported auditory disability, handicap and hearing aid satisfaction. Following this, subjects are randomly assigned to one of two groups. Subjects in Group 1 receive counseling from the experimenter in the form of an explanation and discussion of their PPT results. Subjects in Group 2 also participate in a discussion with the experimenter, but it does not include an explanation of the PPT. Two weeks after enrollment in the study subjects complete a second set of questionnaires. Ten weeks after study enrollment subjects return to the laboratory to rerun the test battery. The impact of the counseling upon PPT values, reported handicap and hearing aid satisfaction and benefit will be compared across the two groups.

Eligibility Criteria:
Inclusion Criteria:

* Mild-to-moderate symmetrical sensorineural hearing loss
* Current users of binaural hearing aids

Exclusion Criteria:

* Conductive hearing impairment or other otological pathology
* A score less than age-based norms on the Mini Mental State Examination
* Asymmetrical hearing loss
* No prior use of hearing aids
Ultrasound Guided Peripheral IV Insertion

Hypothesis The initial use of ultrasound guidance when indicated for difficult peripheral IV access will reduce the number of attempts required to achieve successful peripheral IV insertion and improve patient care and satisfaction.

Study objective The purpose of this research study is to compare 2 established peripheral IV insertion techniques (traditional vs ultrasound guided) in order to develop an algorithmic approach to peripheral IV insertion. Patient characteristics, medical history and co-morbidities, in addition to a pre-insertion physical exam vein assessment, will allow for the introduction of a vein classification system and a difficult IV insertion algorithm. Selecting the optimal modality for initial IV insertion will decrease the total number of attempts, facilitate appropriate gauge and location of IV insertion, avoid central line placement, decrease IV insertion pain scores and improve patient satisfaction. Currently, ultrasound guided peripheral IV insertion is performed by the IV team at Cedars-Sinai Medical Center or a trained anesthesia provider as a rescue technique after multiple failed attempts by traditional technique. Secondary to the constraints of both trained providers and equipment resources, the cohort of difficult IV insertion patients are subjected to multiple traditional IV insertion attempts prior to escalation to ultrasound guidance and occasionally, unnecessary central line placements indicated by only poor intravenous access.

Primary end point: Grade 2A vein classification cohort 2nd IV insertion attempt success rate comparison of traditional vs ultrasound guided technique, IV insertion pain scores, Patient satisfaction Secondary end points: Grade 2B and grade 3 vein classification ultrasound guided IV insertion success rate. Grade 1 and 2a vein classification 1st attempt IV insertion success rate. Grade 1 visualization 2nd attempt IV insertion success rate comparison of traditional vs ultrasound guided technique. Difficult IV insertion risk factors and associations, IV gauge and location, central line placement because of inadequate peripheral IV access

Eligibility Criteria:
Inclusion Criteria:

* All patients requiring pre-operative IV

Exclusion Criteria:

* Emergency Surgery, patient refusal, non-english speaking (USGPIV modality available to them but time restrictive to consent for study), pediatrics
The Effects of tDCS Combined With Balance Training on Lower Limbs Spasticity in Chronic Stroke Patients

Spasticity is one of the most common disorders in patients with central nervous system diseases such as stroke. Transcranial direct current stimulation stimulation (tDCS) is a noninvasive tool that can be used to modulate cortical excitability of the leg motor area, and the spinal motor circuits as well.

Objective:The objectives of this study is to examine the efficacy of anodal tDCS combined with Biodex balance training on lower limbs spasticity in chronic stroke patients using laboratory and clinical assessments.

In a randomized, sham-controlled, double-blinded clinical study, hemiplegic chronic stroke patients are randomized to receive active tDCS delivered to lesioned leg motor cortex (CZ) or sham combined with balance training with Biodex balance system.

Experimental group receive tDCS stimulation (2mA) for 20 min, 5 sessions in five days paired with 20 min balance training.

Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years;
* first-ever ischemic stroke;
* chronic phase of recovery (\>6 months);
* ability to walk 6- meter supported or unsupported;
* ability to stand at least unsupported for 40-seconds with eyes closed;
* only ischemic stroke involving middle cerebral artery (MCA) territory confirmed by CT or MRI.

Exclusion Criteria:

* Use of any neuro- or psycho-active medications that alters balance;
* any other neurological conditions or sensory disorders affecting postural control; such as brain tumor, or substance abuse; orthopedic diseases;
* ongoing/recent (within 3 months) balance rehabilitation.
Copeptin as a Diagnostic Marker in the Management of Neurosurgical Patients With Disturbance of Water Homeostasis

Water imbalance and consecutive electrolyte disturbances are common in the postoperative course of neurosurgical patients after pituitary surgery. Diabetes insipidus (DI) may complicate the postoperative course in as many as 30% of patients. Early and accurate diagnosis of water and electrolyte disturbances postoperatively is important for an adequate fluid and drug administration. However, identifying the causes is challenging/ ambiguous in clinical practice. Levels of antidiuretic hormone (ADH) might contribute to a straightforward diagnosis, though, its measurement is cumbersome. ADH is derived from a larger precursor peptide along with copeptin, which is a more stable peptide directly mirroring the production of ADH. Copeptin can be assayed readily in plasma. Aim: To investigate whether copeptin can accurately diagnose postoperative disturbances of water homeostasis (i.e. Diabetes insipidus and SIADH) in a cohort of patients undergoing intracranial tumor surgery.


Eligibility Criteria:
Inclusion Criteria:

* All consecutive patients who undergo surgery for an intra- or suprasellar lesion, either by craniotomy or by transphenoidal resection.
Cyclosporine A C-2h Monitoring Versus Tacrolimus C-0h Monitoring in de Novo Liver Transplant Recipients

The purpose of this study is to determine whether cyclosporine A (in a micro emulsion formulation) monitored by sample taken 2 hour after oral dose (C-2h) will show equivalent or superior efficacy compared to tacrolimus monitored by pre-dose blood concentration (C-0h). In addition this study will assess the safety and tolerability of a cyclosporine A regimen based on C-2h monitoring in comparison to the standard tacrolimus regimen.


Eligibility Criteria:
Inclusion Criteria:

* About to undergo a primary liver transplant (including living donor, non-heart beating donor and split liver).
* Age between 18 and 75 years.
* Expected to be able to receive the first oral dose of CNI within the first 24 hours post-transplantation (Tx)

Exclusion Criteria:

* This is a multi-organ transplant or if the patient has previously been transplanted with any other organ.
* Urine production is \<200 ml within 12 hours after reperfusion of the graft
* Severe coexisting disease is present or if any unstable medical condition is present which could affect the study objectives.

Other protocol-defined exclusion criteria applied
Long-Term Safety and Efficacy of HB0034 in Subjects With Generalized Pustular Psoriasis

This is a Phase IIb, long term extension study to evaluate the safety and efficacy of HB0034 in adult subjects with generalized pustular psoriasis (GPP).

This study will also evaluate the pharmacokinetic (PK) profile of HB0034 and explore the immunogenicity of HB0034 in subjects with GPP

Eligibility Criteria:
Inclusion Criteria:

* Patients participated in the preceding placebo-controlled Phase 2 study （HB0034-04）and completed at least the Week 12 visit of the HB0034-04 study
* Subject must be a candidate for prolonged GPP treatment according to the Investigator's judgment
* Men and women of reproductive age who have no parenting plans and are willing to use reliable contraception during the study period and for 6 months after the last dose of the study drug;
* Patients who fully understand and voluntarily sign an ICF, and are willing and able to follow clinical study and subsequent visit schedules

Exclusion Criteria:

* Patients who are experiencing GPP flare