cyrilzakka/clinical-trials huggingface dataset:
Yunzhi Essence to Improve the Quality of Life of Patients With Advanced Stage of Cancer

A randomized, double-blinded, placebo-controlled clinical trial using a Chinese Medicine 'Coriolus Versicolor for improving the quality of life of patients with advanced-stage cancer. Subjects will be randomized into a treatment group or placebo group for 6 months.

According to the Compendium of Materia Medica, a classic encyclopedia for Chinese medicines written by the venerated Physician Li ShiZhen of the Ming dynasty, Yunzhi (Coriolus Versicolor) is treasured as a superbly valuable herb as it not only can strengthen and consolidate the body's resistance, as well as reinforce and nourish a person's marrow and kidney essence and also is harmless to patients. Recent research found that the extract from Yunzhi, named as polysaccharide-peptide (PSP), could inhibit the growth of human hematoma cell line \& sarcoma and was proved to have direct anti-cancer effects.

Quality of life (QOL) of patients is the ultimate goal of palliative care as endorsed by the World Health Organization (WHO) in 1990. When survival is limited in advanced incurable diseases, quality of life is most important. Patients with advanced cancer (palliative) often manifest numerous physical and psychological symptoms and a poor quality of life. While maintenance of the quality of life of advanced cancer patients is important, the physical dimension of quality of life still needs improvement, especially in the palliative stage. To date, there is no specific supportive Traditional Chinese Medicine(TCM)-related products that have been proven in randomized controlled trials for alleviating these debilitating symptoms and improving their quality of life. The present study aims to scientifically evaluate whether a Yunzhi product named G.E. Yunzhi-Essence is effective and safe in improving the QOL of palliative patients with advanced cancer.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with advanced cancer according to the definition from American Cancer Society;
* According to the experience of the doctor, by using Palliative Prognostic Index (score\>4), integrated with past cases and professional knowledge judged to have life expectancy not less than six months to two years;
* Abbreviated mental test (AMT) score of 6 or above;
* Voluntarily participate in this clinical trial and sign the informed consent form (acceptance of close relatives signed informed consent on behalf of the patient);
* Refer to the national standard for Clinic terminology of traditional Chinese medical diagnosis and treatment-Part 2:Syndromes/patterns, syndrome of "damp heat spleen" and "spleen deficiency with water stop" (Fulfill 2 of the main symptoms and 2 of the secondary symptoms).

Exclusion Criteria:

* Patients with a history of allergy to traditional Chinese medicine or Yunzhi;
* Patients who required nasal feeding or difficulty swallowing;
* Patients with comatose/semi-conscious, cognitively impaired with dementia/confusion, physically too ill with extremely poor general condition, or there was a language barrier.
Novel Inflammatory Markers in Different Phenotypes of Severe Asthma

Asthma is a highly prevalent chronic airway inflammatory disease characterized by airway hyper-responsiveness, reversible airflow obstruction and increased mucus secretion, involving large and small airways. An emerging sub-phenotype of severe asthma is the late onset disease associated with nasal polyposis, a frequent co-morbidity that significantly impacts lung function and symptom control. On the basis of the infiltrate found in the sputum, asthma can be divided into four distinct phenotypes: eosinophilic, neutrophilic, mixed granulocytic and pauci-granulocytic. The majority of patients with eosinophilic asthma are sensitive to corticosteroids, and biological therapies targeting eosinophils (anti-Interleukin (IL)-5 and anti-IL5R) have been recently approved. However, it is known that some asthmatics, particularly those who have severe disease and are resistant to corticosteroids, have elevated neutrophil counts in the airway where they play a vital role in the exacerbation of the disease. However, the precise role of neutrophils in severe asthma and the mechanisms involved in neutrophil-induced tissue damage have not been clarified yet.

The hypothesis of the study is that neutrophils and eosinophils can contribute to the severity of asthma by changing their phenotypes according to the airway environment. Thus, a better understanding of the roles of neutrophils and eosinophils in severe asthma may lead to the identification of novel biomarkers and the development of new therapeutic approaches in different phenotypes of severe asthma.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* age (18-65 years)
* Diagnosis of severe asthma according to the European Respiratory Society (ERS) and American Thoracic Society (ATS) definition, with and without nasal symptoms
* normal pulmonary function post-therapy (FEV1 post-bronchodilation: greater than 80% of the predicted value, with FEV1/ vital capacity (VC) \> 88-89% - for males and females, respectively - of the predicted value)
* non reversible chronic airflow limitation (FEV1 post-bronchodilation: lower than 70% of the predicted value, with FEV1/VC \< 88-89% of the predicted value)
* Signing of the informed consent

Exclusion Criteria:

* Referred Pregnancy
* Use of therapy with beta-blockers
* Smoking (current or within the previous 3 months)
* Negation to participate to the study
* Current upper and lower airways infectious diseases
* Current systemic infectious diseases
PERiX: Comparison of Efficacy Between Placement of Epidural Catheters X-ray Guided and LOS Technique

The use of epidural catheters for postoperative analgesia in pancreatic surgery is recommended by the guidelines of the ERAS society. Some studies claim it may expose to hemodynamic alterations that may compromise outcome and increase postoperative complications, attributable to a malfunction of the catheter itself, often linked to a bad positioning, since this is usually positioned with LOS technique. Our hypothesis is that a positioning made using the radiographic guide the day before the intervention can significantly reduce the number of catheter's dysfunctions.

About 30% of epidural catheters are reported to have hypo or hyper functioning behaviour. This has and impact on postoperative pain control and can affect also surgical and global outcome since it is known that a malfunctional catheter carries an increased complication's rate.

Our hypothesis is that rx-guided positioning can reduce the incidence of catheter malfunction afrom 30 to 15 %.

Eligibility Criteria:
Inclusion Criteria:

* scheduled for open pancreatic surgery
* ASA \< = 3

Exclusion Criteria:

* scoliosis
* coagulation abnormalities
* antiplatelet drugs (except ASA)
* history of back surgery
* anticipated need of ICU stay
Keto-/Amino Acid Supplemented Low Protein Diet in Patients With Chronic Kidney Disease

Keto-/amino acid supplemented low protein diet can reduce uremic symptoms, improve nutritional status, delay dialysis therapy and enhance health-related quality of life in our patients with stage V CKD in comparison to non-supplemented low protein diet.

Fifty patients will be included into the study. The study comprises 9 visits. The treatment period covers 6 months, preceded by a 2-week screening period and a 1 month run-in period. Patients are required to visit the investigator two times before the start of active treatment.

All patients who are qualified for this study will then be randomised by receiving their medication/introduction of dietary management using the standard simple randomization method.Group I patients will receive keto-/amino acid (Ketosteril) supplemented low protein diet during the active treatment period while Group II patients will receive non-supplemented low protein diet during the same period. The daily dose of keto-/amino acid for each Group I patient is one tablet every 5 kg body weight. The total daily dose will be divided into three times a day.

Eligibility Criteria:
Inclusion Criteria:

* 1. Serum creatinine ≧6 mg/dl at Visit 12. Creatinine clearance \< 15 ml/min at Visit 13. Urine output ≧ 1,000 ml/day4. Primary renal disease: chronic glomerulonephritis or non-diabetic stage Ⅴ chronic kidney disease (confirmed by biopsy or clinical presentations/symptoms)5. Bilaterally reduced renal size shown by sonography6. Male or female patients aged 20 - 657. Ability of the patient to understand the basic implications of the study and to follow instructions8. Willingness to participate as indicated by a signed written informed consent

Exclusion Criteria:

* 1. Severe arterial hypertension not responsive to medical therapy, maximum blood pressure values allowed: 180/100 mm Hg 2. Inadequate caloric intake due to extremely severe uremia (vomiting, anorexia, etc) 3. Malnutrition status with serum albumin level less than 3.5 g/dl in recent one month 4. Lack of adherence to dietary prescription 5. Water and sodium retention not responsive to diuretics 6. Clinical relevant severe cardiac disease, hepatic disorders (total bilirubin \> 1.5 times the upper limit of normal), malabsorption disorders, diseases requiring steroids or non-steroid anti-inflammatory drugs 7. Severe sodium wasting syndrome that may affect renal function markedly and independently of dietary therapy 8. Concurrent use of nephrotoxic drugs 9. Severe infection with catabolic situation 10. Signs of uremic pericarditis 11. Symptoms of uremic polyneuropathy 12. Disorder of amino acid metabolism 13. Pregnant or nursing women 14. Participation in a clinical trial within the last 2 months 15. Former participation in the present study
Impact on the Adverse Event (AE) Incidence of Two Types of Experience Feedback on AE Analyzed During Local Morbidity Mortality Reviews

After implementing a French version of a trigger tool validated for computerized detection of adverse events in patient's medical record, the study will be performed in three parallel randomized arms of three identical departments (each steaming from 6 types of medical, surgical or obstetrical departments with a total of 18 departments involved). This three arms will be: no intervention, education of department's staff by multi professional in situ simulation (adapted to the discovered adverse events), or simple but large diffusion of results and decisions of Morbidity Mortality Reviews.

The interventions will be performed during a two-years period.


Eligibility Criteria:
Inclusion Criteria:

* patients aged \> 18 years old
* patients hospitalized in the involved departments during the two-years intervention's period

Exclusion Criteria:

* patient aged \< 18 years old
* no other exclusion criteria
2nd_Computerized Asthma Specific Quality of Life(cAQOL)

Comparison of the responsiveness of two different asthma-specific QOL measures (AQLQ and cAQOL) in Korean patients with persistent asthma


Eligibility Criteria:
Inclusion Criteria:

* Patient aged 20-70 years
* Patient diagnosed with asthma over six months ago
* Asthma diagnosis

  * Airway reversibility, FEV1 ≥ 12% and 200mL or
  * Airway hyper-responsiveness, PC20 \< 16 mg/mL or
  * More than two weeks, more than 2 times a day in excess of 20% PEFR diurnal variability patient
* FEV1 55-100% of predicted value patient
* Inhaled corticosteroids alone or inhaled corticosteroids and beta agonists used patient
* Currently, at least if you have one or more asthma symptoms, asthma control test (ACT • Asthma Control Test) score of less than 19 characters
* Patients who sufficiently listen to the purpose and content of this trial and the properties of investigational products and voluntarily agree with the participation to sign a written consent approved by IRB of Ajou University Medical Center before the participation in this trial

Exclusion Criteria:

* Current smoking or smoking in the past 15packyears
* Patients who show a symptom of an acute disease within 14 days before the beginning of this trial (administration of trial medication)
* Recent changes in asthma treatment for 28days
* Chronic diseases that affect the quality of life
Safety and Efficacy of SH T00660AA in Treatment of Endometriosis

The purpose of this study is to demonstrate safety and efficacy of SH T00660AA for the treatment of endometriosis

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Female patients with endometriosis-associated pelvic pain

Exclusion Criteria:

* Pregnant or lactating women
* History or suspicion of hormone dependent tumor
* Therapy resistant endometriosis or need for primary surgical treatment
* Any other conditions which forbid the participation
Fecal Microbiota Transplantation and Analysis of Fecal Microbiome in IBD Patients

Fecal microbiome of donor and recipient will be analyzed before and after fecal microbiota transplantation in IBD patients.

Fecal microbiota transplantation will be performed to the IBD patients, and microbial analysis will be done for donor and recipient feces. Fecal microbiota transplantation will be done twice via colonoscopy, with one month of duration. During the early stage of Fecal microbiota transplantation, recipient feces will be analyzed for the intestinal microbiota frequently.

Clinical outcome will be assessed 1month, 2month, 6month, and 1 year after the transplantation.

Relevance of intestinal microbial change and clinical outcome after transplantation and factors associated with successful clinical outcome will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* 7 years old to 80 years old at start of trial
* Inflammatory bowel disease such as ulcerative colitis, Crohn's disease, and Behcet's colitis
* Patients who do not respond to the conventional treatments or who do not wish/not able to use one.
* Patients who agree to participate in the trial after thorough explanation
* Evidence of active disease

Exclusion Criteria:

* Patients whose CRP\<8, calprotectin\<200, and mucosal healing endoscopically (who are in stable state)
* Patients whose symptom is due to other disease than IBD

  _Patients with immunosuppressive disease
* Patients who are clinically unstable such as massive hemorrhage or perforation
* Patients with toxic megacolon, paralytic ileus, or symptomatic intestinal obstruction
* Absolute neutrophil count (ANC) \<1.5 \*10\^9/L (1500/mm3)
* Pregnant or under breast feeding
* Patients enrolled in other clinical trials
Biomarkers for the Surgical Treatment of Rotator Cuff Tears

Identification of biomarkers that can predict the outcome of the surgical treatment (i.e. the rate of re-rupture) of tears in the rotator cuff tendon.

Rotator cuff tears (i.e. structural failure and tissue disruption in at least one of the four muscles and tendons that form the rotator cuff) are extremely common injuries and represent the most common muscle-tendon tear in patients. Repair of rotator cuff tears is usually advocated for painful tears with functional impairment. However, high failure rates of 13-68% have been reported for surgical repair of rotator cuff tears, irrespective of the surgical technique employed. Higher rates of re-rupture are associated with larger tears, increased patient age, and increased fatty degeneration of the cuff muscles. There is no general consensus as to the causes of re-rupture; where mechanical factors, the existing techniques of suturing, and biological factors are considered as the main factors of recurrence.

Eligibility Criteria:
Inclusion Criteria:

* Full-thickness rotator cuff tear (isolated transmural supraspinatus muscle tear or combined with infraspinatus and subscapularis tears) with fat content \<50% (Goutallier stage 0-2), as confirmed by magnetic resonance imaging
* Acute or chronic ruptures
* Older than 40 years of age
* Voluntary participation in this study
* Written informed consent to participate in this study

Exclusion Criteria:

* Contraindication because of ethical reasons
* Pregnant or lactating women
* Intention/wish to become pregnant during the course of this study
* Unsafe contraception
* Clinical co-morbidities, such as renal insufficiency, hepatic dysfunction, cardiovascular disease
* Known or suspected non-adherence to the study protocol
* Smoker
* Drug or alcohol addicted
* Uncapable of following instructions, e.g. because of insufficient proficiency in languages, psychological problems, dementia, etc.
* Participation in other clinical trials during the duration of this study, as well as 30 d before inclusion in this study
* Claustrophobia
* Systemic corticoid steroid therapy
Non-linear Multimodal Microendoscopy for Lung Cancer Pathology

For this study the investigators are looking to do the following:

1. To characterize human lung lesions by nonlinear microscopy using ex vivo tissues.
2. To establish the first spectral/structural database for nonlinear optical microimaging of normal and abnormal lung tissue.

For this study the investigators are looking to do the following:

1. To characterize human lung lesions by nonlinear microscopy using ex vivo tissues. In particular, to investigate collagen content and ultrastructure with SHG (second harmonic generation) microscopy, to characterize cell and nuclear morphology and lipid vesicle content with THG (third harmonic generation) and CARS (coherent anti-Stokes Raman scattering) microscopy and to conduct spectroscopic and lifetime characterization of MPF (multiphoton fluorescence) signals in cancerous, benign, and normal tissues.
2. To establish the first spectral/structural database for nonlinear optical microimaging of normal and abnormal lung tissue, from which to generate diagnostic algorithms, both to optimize the operating parameters of planned nonlinear endoscopic imaging and to serve as the basis for nonlinear optical histopathology.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older.
* Patients with confirmed or suspected lung cancer who require lobectomy as part of standard-of-care.

Exclusion Criteria:

* Patients deemed on clinical grounds not to be medically fit for a lobectomy
* Patients where there is a high clinical suspicion of lymphoma (to avoid mixing the data sets).
* Patients unable to give informed consent
Simulation Trial of Telemedical Support for Paramedics

In the United States, the current standard of prehospital (i.e. outside of hospitals) emergency care for children with life-threatening illnesses in the community includes remote physician support for paramedics providing life-saving therapy while transporting the child to the hospital. Most prehospital emergency medical services (EMS) agencies use radio-based (audio only) communication between paramedics and physicians to augment this care. However, this communication strategy is inherently limited as the remote physician cannot visualize the patient for accurate assessment and to direct treatment.

The purpose of this pilot randomized controlled trial (RCT) is to evaluate whether use of a 2-way audiovisual connection with a pediatric emergency medicine expert (intervention = "telemedical support") will improve the quality of care provided by paramedics to infant simulator mannequins with life threatening illness (respiratory failure). Paramedics receiving real-time telemedical support by a pediatric expert may provide better care due to decreased cognitive burden, critical action checking, protocol verification, and error correction. Because real pediatric life-threatening illnesses are rare, high stakes events and involve a vulnerable population (children), this RCT will test the effect of the intervention on paramedic performance in simulated cases of pediatric medical emergencies.

The two specific aims for this research are:

* Aim 1: To test the intervention efficacy by determining if there is a measurable difference in the frequency of serious safety events between study groups
* Aim 2: To compare two safety event detection methods, medical record review, and video review


Eligibility Criteria:
Inclusion Criteria:

* Certified Emergency Medical Technicians (EMTs), Advanced EMTs (AEMTs), and Paramedics (EMT-Ps) who provide direct scene response.
* Board-certified Pediatric Emergency Medicine (PEM) and Emergency Medicine (EM) physicians whose practice includes online medical support for EMS are eligible.
* The control arm will include physicians who provide radio/telephone support in usual care at each site. In the intervention arm, experts will be PEM with/without EMS board-certification as they have relevant pediatric training and experience.

Exclusion Criteria:

* EMS personnel providing interfacility transport and/or pediatric specialty transport
* Resident physicians-in-training
* Non-physician providers
Multiple-Ascending-Dose Study to Evaluate the Safety of Propoxyphene Napsylate In Healthy Adult Subjects

The purpose of this study is to determine the daily maximum tolerated dose of propoxyphene napsylate in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index ≥ 18 and ≤ 30 (kg/m2)
* Medically healthy with normal screening results, or in the case of results that are abnormal; the abnormal results are clinically insignificant (eg, medical history, physical examination, neurological assessment, vital signs, oxygen saturation, laboratory profiles)
* 12-lead ECGs (calculations by the electrocardiograph) which have no clinically significant findings
* Vital signs which are within normal range
* No tobacco/nicotine-containing product use for a minimum of 6 months
* If female, must be able to adhere to acceptable methods of contraception or be postmenopausal or surgically sterile

Exclusion Criteria:

* History or presence of significant cardiovascular, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, or neurological disease
* History or presence of any degree of chronic obstructive pulmonary disease
* History of suicidal ideations or depression requiring professional intervention including counseling or antidepressant medication
* Any history of drug or alcohol abuse
* Positive drug (urine)/alcohol (breath) testing at screening or check-in
* Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV)
* History of hypersensitivity or allergy to propoxyphene or any opioid compound, naloxone, naltrexone, palonosetron (Aloxi®), glycerin, senna, or bisacodyl (Dulcolax®)
* Use of any prescription medication (with the exception of hormonal contraceptives for females) within 2 weeks of enrollment
* Use of any over-the-counter medication, including herbal products, within 1 week of enrollment
* Use of any drugs known to significantly inhibit or induce liver enzymes involved in drug metabolism \[CYP P450\]) within 30 days of enrollment
* Blood donation or significant blood loss within 30 days of enrollment
* Plasma donation within 7 days of enrollment
* Participation in another clinical trial within 30 days of enrollment
* Females who are pregnant or lactating
* Any other condition or prior therapy, which, in the opinion of the PI, would make the subject unsuitable for this study