cyrilzakka/clinical-trials huggingface dataset:
Effect of Traditional Chinese Medicine on Outcomes in Patients With Mild/Moderate Chronic Obstructive Pulmonary Disease

The purpose of this study is evaluate the effects and safety of Traditional Chinese medicine for prevention and management of mild/moderate chronic obstructive pulmonary disease (COPD).

This is a multicenter, randomized, double-blind, placebo controlled study to evaluate the effect of Traditional Chinese medicine (TCM) in COPD subjects. Following a 14 day run-in period, approximately 504 subjects will be randomly assigned to double-blind treatment for 52 weeks. After the 52 weeks treatment period, subjects in both treatment arms will follow-up 52 weeks. The primary measure of efficacy is the frequency of exacerbations and spirometric values (e.g. FEV1). Secondary efficacy measures include Dyspnea (MMRC), Quality of life ( CAT,SF-36), Exercise Capacity( 6MWD). Safety will be assessed through the collection of adverse events. There will be a total of 5 study visits ( randomization, and after 13, 26, 39 and 52 weeks of treatment). A follow-up contact for collection of effect and adverse event will be conducted approximately 52 weeks following the last study visit.

Eligibility Criteria:
Inclusion Criteria:

* A confirmed diagnosis of mild/moderate COPD.
* Age between 40 and 80 years.
* Syndrome differentiation belongs to Syndrome of lung-qi deficiency, Syndrome of deficiency of pulmonosplenic qi, Syndrome of insufficiency of QI of the lung and kidney.
* Without participation in other interventional trials in the previous one month.
* With the informed consent signed.

Exclusion Criteria:

* Pregnant or breast-feeding women.
* Any psychiatric condition rendering the patient unable to understand the nature, scope and possible consequences of the study .
* Complicated with severe heart failure (class Ⅳ NYHA heart function) or unstable hemodynamics.
* Complicated with bronchial asthma, bronchiectasis or active tuberculosis；
* Complicated with obliterative bronchiolitis or diffuse pantothenic bronchiolitis，
* Complicated with pneumothorax, pleural effusion or pulmonary embolism.
* Complicated with neuromuscular disorder which affects the respiration.
* Complicated with tumors.
* Complicated with serious hepatic and renal diseases.
* Long periods of bed rest.
* Use of oral or parenteral corticosteroids before 1 months of Visit 1 .
* With immunodeficiency.
* Participating in other trials or allergic to the used medicine.
Technical Accuracy and Userfriendliness of a Point-Of-Care C Reactive Protein Device in a Nursing Home Setting

Study to test the technical accuracy and userfriendliness of a Point-of-care C Reactive Protein device (POC CRP device) in comparison with laboratory CRP testing in nursing home residents


Eligibility Criteria:
Inclusion Criteria:

* Older (65 years or older) nursing home residents

Exclusion Criteria:

* Residents not understanding Dutch
Predicting Factors for Mortality in Congenital Heart Disease Patients After Shunt Procedure in Developing Country.

Blalock Taussig (BT) is a palliative procedure that preserves blood circulation to the lungs and alleviates cyanosis in patients with congenital heart diseases and reduced pulmonary blood flow. BT shunt remains a routinely performed procedure in developing countries before definitive surgery. However, evidence on predictors factors of mortality after this procedure is still scarce in Indonesia.


Eligibility Criteria:
Inclusion Criteria:

* All CHD pediatric patients with a previous history of BT shunt procedure.

Exclusion Criteria:

* Pediatric patients with incomplete medical records
A Study of RO4905417 in Patients With Non ST-Elevation Myocardial Infarction (Non-STEMI) Undergoing Percutaneous Coronary Intervention

This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of RO4905417 in patients with non ST-elevation myocardial infarction (Non-STEMI) undergoing percutaneous coronary intervention (PCI). Patients will be randomized to receive an intravenous infusion of either 5 mg/kg RO4905417 or 20 mg/kg RO4905417 or placebo before PCI. Follow-up will be for 4 months.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>18 to \<75 years of age
* Non ST-elevation myocardial infarction
* Woman of childbearing potential will be allowed only if using two acceptable methods of contraception
* Body mass index (BMI) \</= 40 kg/m2

Exclusion Criteria:

* Acute ST-elevation myocardial infarction (STEMI)
* Culprit coronary lesion with a total thrombotic occlusion or a lesion requiring the use of distal embolization protection or thrombectomy devices
* Percutaneous coronary intervention (PCI) within the past 72 hours
* Thrombolytic therapy within the past 7 days
* Major surgery within the past 3 months
* History of cerebral vascular disease or stroke in the past 3 months
* Bleeding disorders
* Inadequately controlled severe hypertension
* Prior coronary artery bypass graft (CABG) surgery
* Decompensated heart failure (oedema and/or rale)
* Acute infection at screening or active chronic infection within 3 months prior to PCI
* Patients known to be HIV positive, patients receiving antiretroviral drugs, or immuno-suppressed patients
* Uncontrolled diabetes mellitus (HbA1C \>10%) at baseline
Observational Study of the Genetic Architecture of Neutrophil-Mediated Inflammatory Skin Diseases

This study investigates the genetic architecture of Neutrophil-Mediated Inflammatory Skin Diseases. After collecting informed consent, all patients' clinical phenotype is graded at inclusion with a detailed case report form and a discovery cohort formed based on the certainty of diagnosis. The DNA of patients in the discovery cohort is analyzed by whole exome sequencing which identifies all protein-coding genetic variants. Subsequently, statistical burden tests are going to identify enrichment of rare coding genetic variants in patients affected by Neutrophil-Mediated Inflammatory Skin Diseases.

The ultimate goal is to reveal the responsible gene(s) that may then be targets for clinical intervention.

Timeframe:

* Collection of DNA for discovery cohort until 05/2016
* Data analysis until 12/2014 for pyoderma gangrenosum, until 12/2016 for other NMID
* Report and data presentation early 2015 for PG, 2017 for other NMID

Eligibility Criteria:
Inclusion criteria:

* History of NMID or active disease.
* Informed consent.

Exclusion criteria:

- No consent to either part of the study.
Effect of Renal Transplantation on Obstructive Sleep Apnea in End Stage Renal Disease Patients (SASinTx)

The purpose of this study is to investigate the effect of renal transplantation on fluid overload and its consequence on the severity of obstructive sleep apnea, in patients with end stage chronic kidney disease. It aims further to investigate the relationship between overhydration, nocturnal rostral fluid shift and the severity of sleep apnea.

Obstructive sleep disordered breathing is more prevalent in end stage kidney disease patients than in the general population, and may participate to the increased cardiovascular mortality observed in this group of patients. Despite a significant increase in knowledge about the harmful effects of obstructive sleep apnea, the pathophysiological mechanisms are poorly understood. Recent observations suggest a causative relationship between overnight fluid displacement from the legs to the neck soft and the severity of obstructive sleep apnea. This mechanism was demonstrated in otherwise healthy subjects, in heart failure patients, and in patients with venous insufficiency. We thus suspect that this pathophysiologic mechanism could explain the increased prevalence of obstructive sleep apnea in patients with fluid overload, including chronic renal failure.

The purpose of this study is to investigate the effect of renal transplantation on fluid overload and its consequence on the severity of obstructive sleep apnea, in patients with end stage chronic kidney disease. It aims further to investigate the relationship between overhydration, nocturnal rostral fluid shift and the severity of sleep apnea.

The severity of obstructive sleep apnea is measured by two attended polysomnographies, a baseline PSG performed before and a follow-up PSG performed 6 month after renal transplantation. Overhydration and leg fluid are evaluated by bioimpedance, performed at the beginning and at the end of each polysomnography. Patients who are not already transplanted 6 months after the baseline PSG will be re-assessed and will be analyzed as control group.

Eligibility Criteria:
Inclusion Criteria:

* moderate to severe obstructive sleep apnea, with an apnea-hypopnea index (AHI) ≥ 15/h
* age ≥ 18 years
* patient with end stage renal disease on waiting list for a renal transplantation (cadaveric or live donor).

Exclusion Criteria:

* unstable congestive heart failure
* active psychiatric disease
* amputation of the lower limbs, proximal to the ankle
Feasibility Study of a Novel Device for Chronic Wounds

The purpose of this study is to evaluate the feasibility and usability of a new portable and compact wound dressing device for the treatment of small chronic skin wounds.

This is an open label study

Eligibility Criteria:
Inclusion Criteria:- Venous stasis ulcer or other chronic wound on the lower extremity that is \>1.5cm and \<10cm at widest point

* The wound must have at least 2 cm of intact epithelium surrounding it.
* A wound such as a pressure ulcer or chronic ulcer on a location other than the lower extremity may also be included in the study if it meets the size requirements and a reliable seal can be achieved.
* Ulcer must not have healed for \>14 days under standard treatment.
* Chronic wound with prior graft placement will be allowed in the study.
* Patient is \>18 years old.
* Willing and able to sign informed consent.

Exclusion Criteria:- Active wound infection.

* 3+ or greater pitting edema of lower extremity
* History of malignancy at wound site. However, wounds that are closing by secondary intent after surgical clearance of prior tumor will be allowed in the study.
* Thick eschar at wound base after debridement.
* Wound location is not amenable to forming an airtight seal and placement of device.
* Ulcers due to inflammatory conditions such as pyoderma gangrenosum, rheumatoid arthritis, vasculitis, cryoglobulinemia, necrobiosis lipoidica diabeticorum, lupus or pancreatic panniculitis, cryofibrinogenemia, calcinosis cutis, scleroderma, Raynaud's syndrome.
* Current smoker (must have quit for \>3 weeks)
* Wound with exposed bone, blood vessels, tendon
* Significant immunosuppression (as determined by the investigator and sponsor) such as high dose prednisone
* Fasting blood sugar \>200 by study personnel administered bedside fingerstick blood glucose
* Ankle brachial index less than lower limit of normal (\<0.60) as performed and determined by licensed physician (necessary only for patients with lower extremity wounds).
* Pregnancy
* Incapable of giving informed consent
* Inability to comply with study procedures including lack of telephone access for week 8 telephone survey
Bronchoscopy With Bronchoalveolar Lavage in Identifying Biomarkers of Response to Immune Checkpoint Inhibitors in Patients With Non-small Cell or Small Cell Lung Cancer

This pilot clinical trial studies how well bronchoscopy with bronchoalveolar lavage works in identifying biomarkers of response to immune checkpoint inhibitors in patients with non-small cell or small cell lung cancer. Bronchoscopy uses a thin, tube-like instrument inserted through the nose or mouth to view the inside of the trachea, air passages, and lungs. Bronchoalveolar lavage washes out the bronchi and alveoli by flushing with a fluid. Bronchoscopy with bronchoalveolar lavage may make it easier to help determine biomarkers that are more present in some cancers than others that will help determine which individuals have a greater or lesser chance of benefiting from immunotherapy.

PRIMARY OBJECTIVES:

I. To discover predictive immune biomarkers of response to immune checkpoint inhibitor therapy in individuals with primary lung cancer.

SECONDARY OBJECTIVES:

I. To determine biomarkers that may be predictive of treatment related adverse events, specifically pneumonitis.

II. To further elucidate lung immunologic microenvironment by performing single cell analysis in addition to mass cytometry (Cytof) on cells of bronchoalveolar lavage.

OUTLINE:

Patients undergo bronchoscopy with bronchoalveolar lavage over 45 minutes.

After completion of study, patients are followed up at 3, 6, 12, and 24 months.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC)
* Candidate to undergo immune checkpoint inhibitor (ICI) therapy for SCLC or NSCLC (ICI as any line of chemotherapy is acceptable) as deemed by individual's treating oncologist
* Enrollment into this study may occur in tandem with other clinical therapeutics trials occurring at Vanderbilt University Medical Center (VUMC) as long as this trial does not violate protocol or inclusion criteria of that study

Exclusion Criteria:

* Coagulopathy with international normalized ratio (INR) \> 2.0 or
* Coagulopathy with platelets (Plt) \< 10 k
* Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
* Subjects with an active or recent history of a known or suspected autoimmune disease or recent history of a syndrome that required systemic corticosteroids/immunosuppressive medications
* Respiratory failure requiring greater than 6 Lpm supplemental oxygen (O2) by nasal cannula or mechanical ventilation within the past six weeks
* Inability to perform informed consent due to any medical or psychiatric condition
Lymphocytic Herpesviruses and Cerebrospinal Fluid Polymerase Chain Reaction (PCR)

Enterovirus and herpes simplex viruses 1 and 2 are the main causative agents of central nervous system infections.

Instead, the role of lymphocytic herpesviruses in the etiology of central nervous system (CNS) infections is not clear, even if there is the positive cerebrospinal fluid (CSF) polymerase chain reaction (PCR)-result for the virus.

The aim of this study is to evaluate the presence of DNA from lymphocytic herpesviruses in the CSF obtained from the immunocompetent patients with CSF pleocytosis and from the patients with normal CSF leukocyte count.


Eligibility Criteria:
Inclusion Criteria:

* Immunocompetent patients with clinical symptoms and signs of central nervous system infections and CSF pleocytosis (pleocytosis group)
* Immunocompetent patients without suspicion of CNS infection and no CSF pleocytosis (non-pleocytosis group)

Exclusion Criteria:

* Suspicion of CNS-infection, eg. encephalitis, but no CSF leukocytosis (pleocytosis group)
* Patients without symptoms of CNS infection, but who has CSF pleocytosis of unknown origin (non-pleocytosis group)
Intensive Care Unit (ICU) Admission Decisions in the Elderly : the ICE-CUB Study

Percentage of patients over 80 admitted in ICU varies greatly from one center to another. ICU admission criteria of older patients are scarcely described and benefit of ICU admission for those patients is uncertain. In this study, we prospectively studied old patients arriving to the emergency department of 15 French hospitals with conditions that potentially warrant ICU admission.The working hypothesis was that ICU admission was associated with a 20% decrease in six-month mortality.

This was a prospective multicenter observational cohort study of elderly individuals presenting to one of 15 emergency departments and possibly qualifying for admission to an ICU. To be included, subjects had to be aged at least 80 years and be diagnosed by the ED physician with one of 74 conditions potentially warranting ICU admission.Outcome studied are ICU eligibility as assessed by emergency and ICU physicians, hospital and six-month death and changes in functional status in the six month following emergency department visit.

Eligibility Criteria:
Inclusion Criteria:

* Age over 80
* Be assigned by the emergency physician with one of 74 conditions potentially warranting ICU admission

Exclusion Criteria:

* Patient's refusal
Prevalence of Major Nutrients Deficiency in Diabetic Patient Before and After Bariatric Surgery

The increasing demand of bariatric surgery requires ongoing improvement of the preoperative and post-operative care of morbidly obese patients. Outcome reporting in bariatric surgery mainly focuses on weight loss, improvement of co-morbidities and quality of life. Post-operative nutritional deficiencies are a complication of bariatric surgery, in particular after malabsorptive procedures. Deficiencies of protein, iron and vitamins B12 and D are frequently reported and may occur despite supplementation. Morbid obesity itself is associated with nutritional deficiencies as well, which become worsening after bariatric surgery. The occurrence of nutritional deficiencies has been reported in the literature but not in Taiwan. The goal of the current study is to determine the prevalence and incidence of nutritional deficiencies in diabetic patients underwent bariatric surgery and receiving standard supplementation in Taiwan.

The increasing demand of bariatric surgery requires ongoing improvement of the preoperative and post-operative care of morbidly obese patients. Outcome reporting in bariatric surgery mainly focuses on weight loss, improvement of co-morbidities and quality of life. Post-operative nutritional deficiencies are a complication of bariatric surgery, in particular after malabsorptive procedures. Deficiencies of protein, iron and vitamins B12 and D are frequently reported and may occur despite supplementation. Morbid obesity itself is associated with nutritional deficiencies as well, which become worsening after bariatric surgery. The occurrence of nutritional deficiencies has been reported in the literature but not in Taiwan. The goal of the current study is to determine the prevalence and incidence of nutritional deficiencies in diabetic patients underwent bariatric surgery and receiving standard supplementation in Taiwan

Eligibility Criteria:
Inclusion Criteria:

* Age: 20\~65
* Diabetic patients underwent bariatric surgery in MSGH

Exclusion Criteria:

* Pregnancy
* Cancer on treatment
* Uncontrolled psychiatric disease
* Drug or alcohol abuser
Tranexamic Acid with Intensive Blood Pressure Management in Ultra-Early Intracerebral Hemorrhage

This is a prospective, multicenter, randomized, quadruple-blind, placebo-controlled study. This study aims to estimate the safety and efficacy of intravenous tranexamic acid (TXA) combined with intensive blood pressure lowering in ultra-early spontaneous intracerebral hemorrhage (ICH).

This trial is designed to evaluate whether tranexamic acid can reduce hematoma expansion and improve functional outcomes when combined with intensive blood pressure lowering in cases of ultra-early intracerebral hemorrhage with a high risk of hematoma expansion.

Participants who meet the eligibility criteria will be randomly assigned in a 1:1 ratio to either the TXA therapy group or the placebo control group. The initial infusion of 1 g of TXA or a matching placebo, along with intensive blood pressure lowering treatment, should commence as quickly as possible, ideally within 30 minutes of randomization. Following this, an additional 1 gram of TXA or a corresponding placebo will be administered via continuous intravenous infusion over 8 hours. Both groups will receive intensive blood pressure management during the first 24 hours after the onset of symptoms. Participants will be followed for 90 days after randomization for efficacy and safety outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 to 80 years old;
2. A definite diagnosis of supratentorial brain parenchymal hemorrhage by non-contrast cranial CT scan;
3. Hemorrhage volume less than 40 mL, as calculated using the ABC/2 method, with ultra-early hemorrhage growth (uHG) 10 mL/h or higher;
4. A clear time of symptom onset, and the randomization must occur within 2 hours from the onset;
5. At least two measurements of systolic blood pressure that are ≥150 mmHg and \<220 mmHg, with at least a 2-minute interval between measurements.;
6. Baseline NIHSS of 8 or higher, or unilateral limb muscle strength of 0-3 grades;
7. GCS score greater than 8;
8. The patient or their legal representative has signed an informed consent form.

Exclusion Criteria:

1. Pre-illness mRS \> 2;
2. Primary thalamic hemorrhage or intracerebral hemorrhage that has extended into the ventricles;
3. Scheduled for surgical intervention (i.e., hematoma evacuation, craniectomy);
4. Secondary ICH from tumors, AVMs, and aneurysms;
5. Traumatic brain injury-related hemorrhage;
6. Recent stroke, TIA, or thrombolytic therapy;
7. On anticoagulants;
8. Blood disorders, platelets \<50,000/µL, or INR ≥1.8;
9. Antihypertensive therapy contraindications;
10. Indications for immediate blood pressure reduction;
11. Active thrombosis or thromboembolic history;
12. Hereditary or acquired thrombophilia;
13. Acquired color vision deficiency;
14. Epilepsy history;
15. GFR \<90 mL/min;
16. Elevated ALT or liver disease;
17. Allergy to TXA or antifibrinolytics;
18. Life expectancy \<12 months;
19. Pregnant or lactating women;
20. In other interventional clinical trials;
21. Other investigator-defined ineligibilities.
Can Addition of Doxycycline Perioperatively Reduce Propionibacterium Acnes in Shoulder Arthroplasty?

The purpose of this study is to investigate antibiotic treatment to target bacteria about the shoulder. This bacteria, Propionibacterium acnes, is detected in many revision shoulder surgeries and is thought to contribute to periprosthetic joint infections, pain, and failure of total shoulder arthroplasty as well as other shoulder surgeries. This study is investigating adding an FDA approved antibiotic that is commonly used for treatment of this bacteria and many common infections. The investigators will take intraoperative cultures to look for the presence or absence of specific bacteria. The investigators are conducting this trial to see if adding another antibiotic to specifically target this common bacteria found around the shoulder will be effective.

Patients undergoing total and reverse shoulder arthroplasty for primary glenohumeral arthritis will be invited to participate in this study if patients meet inclusion and exclusion criteria. Patients will be randomized to receive either standard perioperative antibiotics with cefazolin or to the treatment group to receive doxycycline in addition to cefazolin. Patients will then undergo routine surgical treatment. 3 cultures from the superficial tissue, dermis, and glenohumeral joint will be taken and cultured for 14 days to detect any bacterial growth.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing primary total shoulder arthroplasty at Rush University Medical Center

Exclusion Criteria:

* Patients with prior shoulder surgery of any kind
* Patients with a known infection or history of infection with clinical signs such as elevated erythrocyte sedimentation rate, C-reactive protein, positive culture aspiration
* Patients with a known allergy to doxycycline
* Patients with a known allergy to cefazolin or penicillin