cyrilzakka/clinical-trials huggingface dataset:
The Efficacy and Safety of PEG-rhG-CSF in Preventing Chemotherapy-induced Neutropenia

The purpose of this study is to evaluate the safety and efficacy of PEG-rhG-CSF in preventing chemotherapy-induced neutropenia

Neutrophilic granulocytopenias is one of the most common and most serious complications in chemotherapy. Research shows that about 25% \~ 40% in patients receiving standard chemotherapy can appear neutropenia with fever. It can increase the risk of infection and Chemotherapy related death, and lead to the delay of chemotherapy, and maybe Reduce the curative effect of chemotherapy. RhG-CSF has widely used to prevent neutropenia, but its half-time is short, and need daily injections to maintain the effective blood drug concentration. Patients are with poor compliance, related adverse reaction and medical costs increase. At the same time, some patients appear neutropenia thought RhG-CSF is given. Therefore, how to reduce the frequency of RhG-CSF injections and more effectively prevent neutropenia more effectively, on the premise of ensure the safety of patients to achieve better effect of chemotherapy, has always been the focus of the clinical problem.

Pegylated recombinant human granulocyte-colony stimulating factor(PEG-rhG-CSF) is a first class national new drug developed by domestic pharmaceutical companies. According to some phase Ⅱand phase Ⅲ clinical trials, PEG-rhG-CSF has a good effect. The patients need only one injection for PEG-rhG-CSF each Cycle of chemotherapy, and the effect of rising white blood cell is more smoothly, and it can avoid pain of repeated injection of PEG-rhG-CSF

Eligibility Criteria:
Inclusion Criteria:

1. Provision of informed consent Histologically proven breast cancer
2. Patients need to accept many cycles chemotherapy alone
3. appears III/IV neutropenia after last cycle of chemotherapy, and plan in the subsequent cycle using the same chemotherapy program.
4. KPS≥70
5. Lifetime is expected to more than 3 months
6. Before enrollment,ANC≥ANC ≥1.5×109 /L,Platelet Count (PLT) ≥80×109 /L, White Blood Cell （WBC ）≥3.0×109 /L.
7. Sign Informed Consent Form （ICF）.

Exclusion Criteria:

1. There is any difficult to control infection, or within 72 h before chemotherapy received antibiotic treatment systematically
2. Any abnormal bone marrow hyperplasia and other hematopoietic function was abnormal
3. Suffer from other malignant tumor was not cured, or patients with brain metastasis
4. Total Bilirubin （TBIL）,Alanine Transminase （ALT）,Aspartate aminotransferase(AST)\>2.5×ULN
5. Cr\>1.5×ULN
6. Be allergic to this product or other genetically engineered e. coli sources of biological products
7. Mental or neurological disorders
8. Women with pregnancy or lactation; The childbearing age women refused to accept contraception
9. The investigators think that the person doesn't fit into the group
Physical Capacity of Patients With Chronic Obstructive Pulmonary Disease With and Without Supplementation of Whey

Chronic obstructive pulmonary disease is characterized by obstruction to pulmonary airflow and dyspnea. These characteristics are a consequence of exposure to harmful gases and particles that lead to oxidative stress in the lungs together with an exaggerated inflammatory response. In addition to respiratory impairment, chronic obstructive pulmonary disease has systemic manifestations, nutritional alterations, and exercise limitation. Pulmonary rehabilitation is one of the most effective interventions in the treatment of chronic obstructive pulmonary disease, with one goal being to improve patient capacity. Whey protein supplementation, concomitant with physical activity for patients with chronic obstructive pulmonary disease, aims to stimulate protein synthesis and decrease muscle catabolism that may be caused by exercise. The investigators aimed to evaluate the effects of whey protein supplementation supplementation on the physical capacity, body composition and tissue functionality of patients with chronic obstructive pulmonary disease in a pulmonary rehabilitation program.

A randomized clinical study will be carried out with 62 patients (31 patients per group) with chronic obstructive pulmonary disease who came from specialized departments of the Pulmonology Service of the Hospital de Clínicas of Porto Alegre and were referred to the pulmonary rehabilitation program of this institution. Patients will be evaluated in relation to anthropometry, body composition, blood biochemistry, phase angle, dietary intake, physical capacity, muscle strength and lung function. The data will be processed in the statistical program SPSS version 17.0 and for statistical analysis they will be tested for their normality by the Kolmogorov-Smirnoff test and after this definition will be applied specific tests for parametric or non-parametric data, being they presented in the form of mean and standard deviation or median, minimum and maximum, according to their distribution. The differences will be considered significant for values of p \<0.05.

Eligibility Criteria:
Inclusion Criteria:

* Have been referred for pulmonary rehabilitation for chronic obstructive pulmonary disease diagnosis;
* Stable for the last 3 months and have no contraindications to exercise (no infection, acute myocardial infarction, malignant neoplasms, renal or hepatic disease, ascites / edema or neuromuscular disease);
* Be 40 years or older;
* Being literate;

Exclusion Criteria:

* Being a vegetarian;
* Make use of continuous oxygen;
* Present cognitive or functional changes that limit the execution of any of the proposed tests.
* Body mass index \<21.0 kg / m² and ≥ 35.0 kg / m².
Sevoflurane's Effect on Mitral Valve Annular Velocity in Cardiac Surgery

The purpose of this study is to determine sevoflurane's dose-dependent effect on left ventricular (LV) function in cardiac surgery. The change of tissue Doppler imaging (TDI) of lateral mitral valve annular velocity at three different sevoflurane concentrations would be analyzed by using intraoperative transesophageal echocardiography (TEE)in cardiac surgery patients.

Following data would be determined after 10 min-exposure to each dosage of sevoflurane with 1.0, 2.0 and 3.0 inspired vol% (T1, T2 and T3, respectively) during remifentanil-based anesthesia (1.0 mcg/kg/min) for cardiac surgery (n=14):

1. TDI of lateral mitral annulus at systole (S'), early filling (E') and atrial contraction (A')
2. transmitral flow Doppler at early filling (E), atrial contraction (A), deceleration time;
3. LV-ejection fraction (EF)
4. bispectral index (BIS)
5. phenylephrine-infusion rate
6. other pressure derived hemodynamic parameters:heart rate; systolic, diastolic, and mean blood pressures; systolic, diastolic, and mean pulmonary artery pressures; central venous pressure (CVP), pulmonary capillary wedge pressure (PCWP), mixed venous O2 saturation (SvO2), cardiac index (CI) and stroke volume index (SVI)

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing cardiac surgery

Exclusion Criteria:

* low ejection fraction \< 50% in preoperative transthoracic echocardiography
* atrial fibrillation
* pacemaker
* pericardial and infiltrative myocardial disease
* mitral annular calcification, surgical rings, prosthetic mitral valves
* lateral left ventricular regional wall motion abnormality
* esophageal spasm,stricture, laceration, perforation, and diverticulum
* diaphragmatic hernia,
* history of extensive radiation to the mediastinum
* upper gastrointestinal bleeding
Reducing Readmissions in High-Risk Ostomates

Preventing complications and readmission after ostomy surgery will decrease the cost of healthcare, improve patient safety, reduce the cost of durable medical equipment required by ostomates, ensure continued specialized care is available, and potentially improve both short and long-term quality of life (QOL) for patients by reducing morbidity and mortality associated with ostomy surgery. The purpose of this study is to measure the effectiveness of patient centered interventions/care pathways and to determine the impact on healthcare utilization, 30-day hospital readmissions, and QOL.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled to undergo surgery that will result in the creation of an ileostomy.
* Agreed to receive home healthcare.
* At least 18 years of age.
* Speaks English.
* Has access to telephone.
* Able to understand and willing to sign an IRB-approved written informed consent document.

Exclusion Criteria:

-Unwilling or unable to receive home health care.
Autonomous Robotics for Transcatheter Cardiac Procedures

Cardiovascular diseases represent the most common cause of death worldwide. Percutaneous approaches with intravascular catheters are pivotal, since they allow to treat patients with high perioperative risks. However, catheter-based treatments require steep learning curves and are characterized by poor ergonomics and exposure to damaging radiation. ARTERY will offer a radiation-free approach based on shared-autonomy robotic catheters, with increased user engagement and easy interaction. Intraprocedural three-dimensional echocardiography as well as computed tomography images obtained during usual clinical practice will provide artificial intelligence algorithms that will turn catheter navigation to a simple task. Optical and electromagnetic sensing techniques will ensure a superior view upon the cardiovascular anatomy and will guide the autonomous catheter upon the interventionist supervision, who will be able to take over control at any instant.


Eligibility Criteria:
Inclusion Criteria:

* adult patients
* patients admitted to hospital undergoing percutaneous cardiac procedure
* patients able to give informed consent

Exclusion Criteria:

* age \<18 years
* refuse to give informed consent
Adaptation of Locomotor Activity in Patients Suffering From Hip OA - Analysis of This Adaptation as a Prognostic Criterion for Future Disease Progression

To assess the prognostic value of a characteristic evaluation of gait in persons suffering from hip OA for subsequent indications for THR.


Eligibility Criteria:
Inclusion Criteria:

* Men or women aged between 45 and 75 years Suffering from primary hip osteoarthritis defined according to ACR criteria who presented pain in the hip for at least one month in the preceding 3 months Radiological stage II, III or IV hip OA according to the Kellgren and Lawrence classification Patients able to understand simple instructions des packaging instructions, to give their written informed consent.

Exclusion Criteria:

* Indication for THR at the time of inclusion. Pregnant or breast-feeding women Alzheimer's disease Chronic respiratory insufficiency with clinical manifestations Parkinson's disease Motor neuron disease Major musculo-skeletal disorder (other than hip OA) Severe non-stabilised diabetes Non-stabilised hypertension Hip OA inflammation flare Rapidly-destructive hip OA Radiography to evaluate structural evolution of the disease done more than 12 months previously Presence of OA in another joint, or another osteoarticular or periarticular disease of the lower limbs with, in the opinion of the patient, disability due to this other disease that is greater than the disability caused by the hip OA.

Spine disease causing gait disturbance (radiculalgia, lumbar canal stenosis,... with, in the opinion of the patient, disability due to this other disease that is greater than the disability caused by the hip OA.)
GlideScope Versus Direct Laryngoscope for Emergency Intubation

The purpose of this study is to assess if the GlideScope video laryngoscope is superior to the Macintosh direct laryngoscope for definitive airway management in acutely-injured patients.

On admission to the emergency department following traumatic injury, many patients require placement of an artificial airway to support their breathing, provide oxygen and protect their airway. This procedure is accomplished through a number of different techniques and few studies have compared these techniques in order to establish the best method. We will compare an older technique using a metal handle and blade that allows for direct visualization of the vocal cords (direct laryngoscopy) to a newer technique that employs a fiberoptic bundle imbedded in a handle that allows indirect visualization of the vocal cords during placement of the artificial airway. The newer technique has the theoretical advantage of being more useful in patients with abnormal airways which are frequently encountered in trauma patients. Since both techniques are currently employed routinely in our institution, we will randomize all trauma admission to have an initial attempt with one of the two techniques in order to perform a randomized, unblinded trial.

Eligibility Criteria:
Inclusion Criteria:

* require emergency intubation

Exclusion Criteria:

* age \< 18
* require surgical airway on initial assessment
* have known or strongly suspected spinal cord injury
Tiotropium Bromide in Cystic Fibrosis

To date, there have been no formal clinical studies completed using tiotropium in CF patients. While there is a large body of evidence demonstrating the efficacy and safety of tiotropium in patients with Chronic Obstructive Pulmonary Disease (COPD), relatively little is known about its efficacy and safety in patients with a diagnosis of cystic fibrosis. Therefore, Boehringer Ingelheim proposed to profile the long acting anticholinergic tiotropium and to generate adequate clinical data for use as a bronchodilator in paediatric and adult CF. The phase III trial (205.438) is a part of the approved Paediatric Investigation Plan (PIP) agreed for Spiriva® Respimat® in Cystic Fibrosis.


Eligibility Criteria:
Inclusion criteria:

1. Patients with a documented diagnosis of Cystic Fibrosis (CF) (positive sweat chloride \>=60 mEq/liter, by pilocarpine iontophoresis) and/or a genotype with two identifiable mutations.
2. Male or female patients (children less than 12 years and adolescents \>12 years).
3. Patients \>=5 years of age must be able to perform acceptable spirometric maneuvers, according to the American Thoracic Society (ATS) standards.
4. Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) \>25% of predicted values.
5. Pre-bronchodilator FEV1 at Visit 2 must be within 15% of FEV1 at Visit 1.
6. No evidence of respiratory tract infection and no pulmonary exacerbation requiring use of intravenous/oral/inhaled antibiotics, or oral corticosteroids within 2 weeks of screening.
7. The patient or the patient's legally acceptable representative must be able to give informed consent.
8. Patients who are on a cycling TOBI® regimen must have completed at least 2 cycles every other month TOBI® administration prior to the screening visit.
9. Patients who are on daily inhaled antibiotic use must be stabilized for at least 6 weeks prior to Visit 1 (screening).
10. Patients having previously participated in study 205.339 can also be selected.

Exclusion criteria:

1. Patients with a known hypersensitivity to study drug
2. Patients who have participated in another study with an Investigational drug within one month preceding the screening visit.
3. Patients who are currently participating in another trial. Observational studies are allowed. Permission should be obtained from sponsor of other study.
4. Patients with known relevant substance abuse, including alcohol or drug abuse.
5. Adolescent and adult female patients who are pregnant or lactating, including females who have a positive serum pregnancy test at screening.
6. Female patients of child bearing potential who are not using a medically approved form of contraception.
7. Clinically significant disease or medical condition other than CF or CF-related conditions that, in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data. Patients with diabetes may participate if their disease is under good control prior to screening.
Restorelle Direct Fix Anterior and Posterior (A&P) for Female Pelvic Organ Prolapse: A Prospective Post Market Study

This is a prospective, multi-center study designed to assess the palpability of the Restorelle Direct Fix A\&P mesh after vaginal reconstruction surgery.


Eligibility Criteria:
Inclusion Criteria:

* Adult female at least 18 years of age
* Willing and able to provide written informed consent
* Diagnosed with clinically significant pelvic organ prolapse of Stage 2 or higher as determined by Pelvic Organ Prolapse Quantification System (POP-Q) requiring surgical intervention in the anterior and/or posterior compartment
* Willing and able to complete all follow-up visits and procedures indicated in the protocol

Exclusion Criteria:

* Concurrent surgical treatment of pelvic organ prolapse using anything other than the Restorelle Direct Fix A\&P
* Confirmed Stage 2 or higher prolapse as determined by POP-Q for a compartment that is not being repaired in the same procedure
* Previous pelvic organ prolapse repair using synthetic grafts
* Patients requiring a total hysterectomy (i.e. removal of the cervix) at the time of vaginal reconstruction
* Patients requiring a procedure for fecal incontinence (i.e.) anal sphincteroplasty) at the time of vaginal reconstruction
* Pregnant or a desire to become pregnant
* Previous radiation or other treatments for cancer in the pelvic area
* Immunosuppression and/or current systemic steroid user
* On any anticoagulation therapy at the time of implant or with bleeding diathesis
NewBreez for Airway Protection in Head and Neck Cancer Patients With Chronic Aspiration

Laryngeal dysfunction is a problem that affects many patients after laryngeal cancer therapy (surgery or radio/chemotherapy). Laryngeal dysfunction is associated with higher incidences of aspiration and respiratory tract complications such as aspiration pneumonia. Current standard of care treatment to reduce the consequences of aspiration is often a tracheostomy which has its own risks and complications. The proposed study aims to describe the performance of a new CE marked medical implant, the NewBreez, in protecting the patient's airways from aspiration.

Aspiration is associated with respiratory tract infections, reduced quality of life and increased mortality in patients. For chronic or unresolved aspiration, patients are often given a tracheostomy for safer breathing and greater protection of the airways from aspirated material. However tracheostomies are associated with risks and complications and do not give a 100% guarantee of aspiration protection to the patient. They also impact the quality of life in a negative way for many patients. The current study will evaluate the performance of a new intralaryngeal device for airway protection in a small group of patients who have chronic aspiration. The study will look at the overall performance of this device in preventing aspiration in this specific group of patients as well as determine any unforeseen risks of using this device in the identified group of patients. The outcomes will form the basis of future studies with larger groups of patients.

Eligibility Criteria:
Inclusion Criteria:

* History of head and neck cancer
* Chronic aspiration
* Currently has a tracheostomy
* Patient is able to independently maintain their tracheostomy and cannula apparatus
* Patient meets the CE Mark indications and are not contraindicated for a NewBreez procedure.
* Anatomically compatible with the available sizes of NewBreez®
* 18 years of age or older
* Sufficient cognitive function to comply with the study and follow-up requirements
* Patient gives voluntary signed informed consent

Exclusion Criteria:

* Recurrent or present cancer in the previous 12 months
* Absent cough reflex
* Severely disrupted swallowing function e.g. severe neurological deficit, absent swallowing reflex, severe fixation of the larynx due to scarring with absent elevation of the larynx
* Upper esophageal sphincter not functional e.g. remains closed
* Cor Pulmonale / Pulmonary Heart Disease, or current lung infection
* Mouth opening less than 3.5cm
* Neck extension severely restricted hindering implantation of the device
* Contraindication to general anesthesia
* Severe hyperostosis (spondylophytes) of the cervical vertebrae causing dysphagia
* Severe (radiogenic) edema or damage of the mucosa of the upper aerodigestive tract
Experimental Medication For the Treatment of Generalized Anxiety Disorder

The purpose of this study is to determine whether an experimental anti-anxiety medication is effective in the treatment of Generalized Anxiety Disorder.

Protocol 04-001-01

The primary objective of the study is to assess, under controlled conditions, the safety and efficacy of an experimental anti-anxiety medication relative to placebo in subjects with generalized anxiety disorder (GAD).

The secondary objective of the study is to study algorithms for discontinuation of an experimental anti-anxiety medication.

Recruiting: Participants are currently being recruited and enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Subjects 18 to 65 years of age will be eligible to participate if they satisfy the DSM-IV-TR criteria for the diagnosis of GAD.

Exclusion Criteria:

* No other primary psychiatric diagnosis besides GAD.
Combined Cataract Surgery and Planned Descemetorhexis

A pilot study designed to assess the feasibility of planned descemetorhexis for the treatment of Fuchs' corneal dystrophy.


Eligibility Criteria:
General Inclusion Criteria:

* Patient \>18 years old
* Willing and able to provide informed consent

Ocular Inclusion Criteria (all ocular inclusion criteria apply only to the study eye):

* Fuchs' corneal dystrophy diagnosed
* Cataract present
* Best corrected visual acuity ≤ 20/40
* Candidate for current endothelial transplant procedure (DSAEK, DMEK)

General Exclusion Criteria:

* \<18 years old
* Medically unstable patient
* Monocular patient
* Unwilling or unable to provide informed consent

Ocular Exclusion Criteria (all ocular exclusion criteria apply only to the study eye):

* Corneal dystrophy other than Fuchs'
* Central corneal scar or central opacity not related to Fuchs'
* Severe nonproliferative diabetic retinopathy or proliferative diabetic retinopathy
* History of prior vitreoretinal surgery
* Advanced or unstable glaucoma
* Known steroid responders with glaucoma