cyrilzakka/clinical-trials huggingface dataset:
Steroid-Eluting Stent Implant for the Treatment of Radiation-Related Sinusitis

Sinusitis is one of the most common sequelae after radiotherapy among nasopharyngeal carcinoma patients. While local steroids have been shown to be effective in the management of patients with chronic rhinosinusitis, their role in treating radiation-related sinusitis is ambiguous. Poor adherence to nasal steroid spray often contributes to the failure of symptom relief. The aim of this study is to determine if steroids stents implantation into the sinuses could improve patient outcomes in radiation-related sinusitis.

Investigators aim to assess the efficacy and safety of Steroid-eluting stents when implanted in sinus in patients with radiation-related sinusitis. This phase III randomized controlled study enrolled nasopharyngeal carcinoma patients who received radiotherapy and developed severe radiation-related sinusitis. Subjects were randomly assigned to receive steroid-eluting stents implantation or nasal steroid spray. All study patients also received saline rinses.

Eligibility Criteria:
Inclusion Criteria:

* pathologically confirmed nasopharyngeal carcinoma patients
* finished radical radiotherapy (≥66Gy) for at least 3 months
* tumor complete response
* received appropriate medical treatment for sinusitis during or after radiotherapy
* confirmed sinusitis according to European Position Paper on Rhinosinusitis and Nasal Polyps 2020
* SNOT-22 ≥ 20 and MRI Lund-Mackay score \> 8
* 18-70 years old

Exclusion Criteria:

* anatomic variation resulted in occluded ostiomeatal complex
* Karnofsky score ≤ 70
* life-threatening medical conditions
* tumour residue or recurrence
* acute bacterial sinusitis or acute fungal sinusitis
* cystic fibrosis or primary ciliary dyskinesia
* dependence on prolonged corticosteroid therapy for comorbid conditions
* history of allergy to topical steroids
* pregnant or breastfeeding
Endoscopic Full Thickness Resection of Gastric Subepithelial Tumors (FROST)

Prospective observational trial. A full thickness resection of gastric subepithelial tumors is performed after application of full thickness sutures underneath the tumor with the GERDX(TM) device. Hypothesis: This endoscopic method is feasible, effective and safe.


Eligibility Criteria:
Inclusion Criteria:

* presence of a subepithelial gastric tumor with signs of potential malignancy in endoscopic ultrasound
* age 18 years or older
* participant has given informed consent

Exclusion Criteria:

* tumor size \> 40 mm (endosonographic measurement) or large extramural tumor mass
* signs of systemic dissemination of tumor
* current presence of a different neoplastic disease (except after successful curative treatment without continued medication)
* former surgery or disease of esophagus or stomach that impedes insertion of the suturing device
* moribund patient
* limited possibility to give informed consent (e.g. language barrier, psychiatric disease)
* pregnancy and lactation period
Tangji Gastric Bypass Stent Study for Obesity

The Gastric Bypass Stent System is intended to be used in weight loss treatment for obesity in patients with a BMI ≥ 30 kg/m2. In this clinical investigation the Sponsor seeks to demonstrate the safety and performance of the Gastric Bypass Stent System for its proposed indication in weight loss treatment for obesity in the China.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-60 years, both male and female;
2. Obese patients with BMI ≥ 30 kg/m2, who are willing to be treated with Gastric Bypass Stent System or dietary intervention;
3. Patients with ASA I\~II grade;
4. The patient understands the onjective of the trial and is volunteered to participate in the trial and has signed the Informed Consent Form (ICF).

Exclusion Criteria:

1. Have a weight loss of more than 4.5 kg in the past three months, or take weight-loss drugs in the past month;
2. Patients who used non-steroidal anti-inflammatory drugs (NSAIDs) and corticosteroids in the past month;
3. Patients diagnosed with type 1 diabetes;
4. Patients with the function of islet β cell basically lost, C-peptide ≤ 1/2 of the normal low limit or low and flat C-peptide release curve under glucose load;
5. Patients with iron deficiency or iron deficiency anemia;
6. Patients with coagulation dysfunction who used aspirin and other anticoagulants in the past month;
7. Patients with severe liver and kidney dysfunction, and the serum creatinine concentration of greater than 180 μmol/L;
8. Patients with Class III heart function of NYHA or higher, or pulmonary dysfunction;
9. Patients who have undergone ERCP procedure, or have a history of cholecystitis or liver abscess;
10. Patients with duodenal ulcer, gastric ulcer or previous and existing pancreatitis;
11. Patients with gallstones (diameter ≥ 20 mm) with clinical symptoms;
12. Patients with thyroid dysfunction;
13. Patients with hemorrhage or potential hemorrhage in the digestive tract;
14. Patients with gastrointestinal tract anomalies, such as gastrointestinal tract atresia, or other conditions that would result in failed placement in the gastrointestinal tract;
15. Patients with a history of bowel obstruction or related diseases in the past year;
16. Patients with a history of systemic lupus erythematosus or scleroderma;
17. Patients with severe infections that are not controlled, not suitable for a procedure;
18. Patients with poor general condition and having endoscopic contraindications (as evaluated by the investigator);
19. Pregnant women or women having the plan for pregnancy;
20. Drug abusers or alcohol addicts or patients with uncontrollable mental illness;
21. Patients who participated in other clinical trials of drugs or medical devices before enrollment and do not reach the endpoint time limit;
22. Patients who participated in other clinical trials of drugs or medical devices before enrollment 3 months.
23. Patients with any other conditions evaluated by the investigators as unsuitable for participating in the trial.
Surgical Techniques in Diabetes Mellitus-II and Obesity. Metabolic Surgery Study (MSS)

The aim of this study is to compare clinical and laboratory findings of three surgical techniques in metabolic surgery in patients with type II diabetes mellitus and obesity (BMI\> 30).


Eligibility Criteria:
Inclusion Criteria:

* BMI 30-40
* Diabetes Mellitus type II less than 10 years of evolution.
* Anti-GAD, anti-pancreatic islets negative antibodies.
* C peptide normally between 0.9 and 4.
* Glycosylated hemoglobin greater than 6.5%.
* Less than 5 years of use insulin.

Exclusion Criteria:

* Cirrosis hepática.
* coagulopathies.
* Type 1 diabetes.
* HIV positive.
* Stomach or small intestine previous surgeries .
* Diseases of the exocrine pancreas: pancreatitis, pancreatectomy, neoplasia, cystic fibrosis, hemochromatosis.
* Endocrinopathies: acromegaly, glucagonoma, Cushing's syndrome, pheochromocytoma, hyperthyroidism, somatostatinoma, aldosteronoma.
* Genetic syndromes with diabetes.
A Phase 2 Study of LY3209590 in Participants With Type 2 Diabetes Mellitus

The reason for this study is to see if the study drug LY3209590 is safe and effective in participants with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have type 2 diabetes mellitus according to the World Health Organization (WHO) criteria treated with a stable dose of metformin in combination with a stable dose of Dipeptidyl Peptidase IV (DPPIV) inhibitor and/or a Sodium-glucose co-transporter-2 (SGLT2) inhibitor for at least 3 months prior to screening
* Participants must have a HbA1c value of 7.0% to 9.5%, inclusive
* Participants must have a body mass index (BMI) between 20 and 45 kilograms per meter squared (kg/m²), inclusive

Exclusion Criteria:

* Have type 1 diabetes mellitus or latent autoimmune diabetes
* Have any episodes of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening
* Have any of the following cardiovascular (CV) conditions: acute myocardial infarction, New York Heart Association Class III or IV heart failure, or cerebrovascular accident (stroke)
* Have acute or chronic hepatitis, or obvious clinical signs or symptoms of any other liver disease
* Have an estimated glomerular filtration rate (eGFR) \<30 milliliters/minute/1.73 m²
* Have active or untreated cancer
* Are receiving chronic (\>14 days) systemic glucocorticoid therapy
Echocardiography as Risk-Assessment for Major Adverse Cardiac Events in Major Vascular Surgery Patients

Patient with coronary artery disease (CAD), heart failure and abnormal heart function undergoing major vascular surgery have a high associated high morbidity and mortality with myocardial infarction accounting for 33-50% of perioperative deaths. The prevalence of CAD in vascular surgery patients approaches 50%. Proper pre-procedure protocols to accurately assess patients and determine who may require further medical optimization prior to undergoing surgery help mitigate risk and improve outcomes. The investigators designed this study as a single center, retrospective cohort analysis to explore the association between ventricular (LV and RV function) and valvular (Aortic / Mitral / Tricuspid) function and expanded major adverse cardiac events (X-MACE).


Eligibility Criteria:
Inclusion Criteria:

* Major vascular surgery operation (e.g. CEA, open aortic repair, suprainguinal and infrainguinal bypasses, EVAR, TEVAR) captured in the UVA Vascular Quality Initiative database
* Echocardiography within two years of index operation

Exclusion Criteria:

* If patient had additional qualifying vascular procedure within 30 days of the index operation, this procedure was excluded
CKD-11101 Phase 3 IV Study in Patients Who Had Renal Anemia Receiving Hemodialysis

The aim of this study was to compare and evaluate efficacy and safety of intravenous CKD-11101 versus Darbepoetin alfa in patients who have renal anemia receiving hemodialysis.

This study was designed as randomized, double-blind, multi-center, Phase 3 clinical study to evaluate the efficacy and safety of intravenous CKD-11101 versus Darbepoetin alfa in patients who had renal anemia receiving hemodialysis.

The selection criteria are evaluated for 19-year-old patients who receive stable hemodialysis treatment for 3 months or more in patients with chronic renal failure. After completion of the stabilization period of 12 to 16 weeks for Darbepoetin Alfa, the subjects with the mean Hb levels of 10 to 12g/dl measured during the baseline visit and 0 week visit are randomized to the test and control groups in a 1:1 ratio during the randomization visit. They have a 20-week maintenance period and a 4-week evaluation period.

Eligibility Criteria:
* Inclusion Criteria

  1. Patients with 19 years of age or older
  2. Patients with anemia in chronic renal failure
  3. Patients who started hemodialysis more than 3 months ago and receive appropriate hemodialysis, satisfying the following criterion:

     -Kt/V is ≥ 1.2 or Urea reduction ratio is ≥ 65%
  4. Patients with the mean Hb levels of 10 to 12g/dl measured at the baseline and randomization visits
  5. Patients with enough body iron stores who meet the following item:

     -Serum ferritin ≥ 100ng/ml or Transferrin saturation ≥ 20%
  6. Patients who have provided written consent to participate in the trial voluntarily
* Exclusion Criteria

  1. Patients with uncontrolled hypertension
  2. Patients who had hypersensitivity to erythropoietin agents
  3. Patients who had known hypersensitivity to mammalian cell-derived products or diluting agents
  4. Patients with history of severe cardiovascular diseases
  5. Patients who have received red blood cell transfusion or hormone therapy for anemia correction within 12 weeks prior to randomization
  6. Patients whose anemia is not caused by chronic renal failure or may affect anemia correction
  7. Patients whose AST/ALT test results performed at screening exceed twice of normal upper limit
  8. Patients who had experience of positive result in anti-erythropoietin antibody in previous treatment with erythropoiesis stimulating agent
  9. Patients who have been planned to change the dialysis method
The Intrepid Clinical Engineering Study

The purpose of this research study is to collect clinical data to validate a software update for 12-lead electrocardiogram monitoring.

The purpose of this study is to validate the Philips DXL electrocardiogram Algorithm works as intended in the HeartStart Intrepid Monitor/Defibrillator after a software update was completed to address instances of high impedance. This study will also determine the diagnostic quality of the 12-lead electrocardiogram tracing from the HeartStart Intrepid Monitor/Defibrillator.

Eligibility Criteria:
Inclusion Criteria:

* Able to read, write, speak, and understand English
* Age: 29 days to 89 years
* Willing and able to provide informed consent and complete study procedures
* Willing to have Philips representatives present during study procedures.

Exclusion Criteria:

* Known allergy to medical adhesives, silicone, or latex (per self-report)
* Any limitation or medical condition, including but not limited to physical or cognitive disability, that would affect the participant's ability to complete study activities (per investigator)
* At the time of enrollment, current enrollment in any other interventional research study
* An employee, or residing family member of an employee, of a company that designs, sells, or manufactures monitor/defibrillator technology or related products (including Philips)
Registry for Vascular Trauma and Follow-up Examinations

Within the framework of the project presented here, a registry for traumatic vascular injuries will be established at Augsburg University Hospital. Patients who are treated at our hospital for an isolated vascular trauma or a vascular involvement in (poly-)trauma will be included. This is a rare complication of trauma, so data collection in a registry is useful to pool data on therapeutic procedures and outcome.

These patients differ from the usual vascular surgery patient clientele because there is usually no previous vascular disease. Healthy vessels show different physiological responses than pre-diseased vessels. The usual therapeutic procedures and materials are also developed for arteriosclerotic or aneurysmatic vessels. Therefore, a core objective of this study is to assess long-term outcomes after vascular trauma.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years
* Vascular involvement in trauma
* Isolated vascular injury
* Written informed consent, except for those deceased from trauma sequelae

Exclusion Criteria:

* Minority
* Lack of consent
Clinical Trial to Evaluate Efficacy and Safety of ROVASRO 10mg Versus CRESTOR 10mg in Hypercholesterolemic Patients

This 8 weeks, prospective, single center, randomized, open-label, parallel-group, non-inferiority study was performed from October 2015 to April 2018. This study as designed to evaluate the efficacy and safety of 10mg of the generic formulation (rosuvastatin, ROVASRO®) compared to the reference formulation (rosuvastatin, CRESTOR®) in patients with primary hypercholesterolemia and complex dyslipidemia.


Eligibility Criteria:
Inclusion Criteria:

1. Individuals aged between 19 and 80 years old.
2. The following patients who belong to the low-risk group to the very-high risk group according to 2015 Korean guidelines for the management of dyslipidemia (Committee, KCJ 2016).

   * Very high risk group (coronary artery disease, ischemic stroke, peripheral vascular disease) were not receiving lipid-lowering agents (statins) within 4 weeks of the screening, regardless of LDL-C levels
   * High risk group (carotid artery disease, abnormal aneurysm, diabetes)\* : LDL-C ≥ 100 mg/dl
   * Moderate risk group (2 or more major risk factors)\* : LDL-C ≥ 130 mg/dl
   * Low risk group (less than 1 major risk factors)\* : LDL-C ≥ 160 mg/dl

     * If the patients taka a lipid-lowering agents (statin) within 4 weeks of screening, enrolled them after wash-out for 4 weeks or more.
3. Patients who voluntarily participated in the trial and obtained document consent.

Exclusion Criteria:

1. a history of acute arterial disease (patients with unstable angina myocardial infarction, transient ischemic attack, cerebrovascular disease, coronary artery bypass graft or percutaneous transluminal coronary angioplasty within 3 months prior to study enrollment)
2. uncontrolled hypertension (systolic blood pressure ≥180mmHg or diastolic blood pressure ≥100mmHg)
3. uncontrolled diabetes (hemoglobin A1c ≥9% or fasting glucose ≥160mg/dl)
4. uncontrolled thyroid dysfunction (thyroid stimulation hormone ≥1.5 times the upper limits of normal (ULN))
5. usage of antihyperlipidemic drugs (bile acid sequestrants, fibrates, niacin, etc.) within 4 weeks before enrollment
6. a history of myopathy, rhabdomyolysis or elevated serum creatinine kinase (CK) more than 2 times the ULN
7. chronic kidney disease (serum creatinine ≥2 times the ULN)
8. elevated liver enzymes (aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥2 times the ULN)
9. a history of drug or alcohol abuse
10. a history of gastrointestinal surgery or gastrointestinal tract disorders
11. hypersensitivity to the components of this drug
12. those who disagree with contraception
13. pregnancy and/or lactation.
Stroke Rehabilitation Utilizing Therapeutical Methods Designed for Nature Environments

Outpatient participants with a recent stroke diagnoses receive complimentary rehabilitation. The nature interventions include ergo- and physiotherapeutic and neurocognitive tasks with the support of an psychotherapeutic frame designed to be performed in a nature environment.

Patients with an acute stroke are recruited to the study when signing out from the acute hospital care services. The patients are selected randomly into two groups: intervention and control groups in proportions 1:1. During the four-week study period the partipants in the control group are encouraged to maintain light physical activity 1 to 3 times per week with or without company. The research worker contacts the participants every week. In the nature group the research worker organises individual nature visits in the nearby nature twice a week and encourages the participants to go outdoors with a close-one once a week. All interventional contacts in the nature group are performed in a ecopsychotherapeutical frame consisting of ergo- and physiotherapeutic and neurocognitive tasks.

Eligibility Criteria:
Inclusion Criteria:

* Acute stroke

Exclusion Criteria:

* Traumatic intracranial bleeding without stroke
* A malign, aggressive disease
* Severe aphasia or incapable of independent decision making
Preferred Consent Models for Secondary Uses of Biospecimens Among Diverse Women

Research with stored biospecimens can provide substantial societal benefits, including greater understanding of cancer etiology and discovery of new cancer therapies, but one critical social and ethical issue is the use of samples for research unplanned at the time of biospecimen collection. Various models for consent (i.e., no consent, notice, opt-out, broad consent, study-specific consent) have been proposed for secondary research use of biospecimens, but empirical data on individuals' preferences for different consent models are limited, particularly from those with limited health literacy and from racial and ethnic minority groups. It is critically important to understand the consent preferences of diverse individuals, as participation of all population subgroups in biobanks is essential to reach translational cancer research goals. Based on a social ecological conceptual framework, the investigators will examine preferences for consent models for secondary research uses of biospecimens among a racially and socioeconomically diverse sample of women 35 years of age and older. The investigators aim to compare experimentally the effect of consent model on intentions to donate biospecimens for future research use among a diverse sample of women. The investigators hypothesize that women will have stronger intentions to donate based on the broad model of consent and the study-specific model of consent compared with the notice model of consent. These findings from groups underrepresented in research will be critical since the participation of these groups in biobanks is essential to generating findings that will achieve translational research goals of eliminating cancer disparities.


Eligibility Criteria:
Inclusion Criteria:

* 35 years old or older
* Proficient in English
* Identifies as Non-Hispanic
* Identifies as African-American or Black
* Identifies as Caucasian or White
* Identifies as Female

Exclusion Criteria:

* Under 35 years old
* Not proficient in English
* Identifies as Hispanic
* Identifies as a race other than African-American or Black; or Caucasian or White
* Identifies as more than one race
* Identifies as Male
Helicobacter Pylori Rescue Treatment Containing Tetracycline in Patients Allergic to Penicillin

The purpose of this study is to assess and compare the effectiveness of furazolidone-tetracycline-containing and tinidazole-tetracycline-containing quadruple regimens for the rescue treatment of Helicobacter pylori infection in patients allergic to penicillin.

Helicobacter pylori(H.pylori), which infects about 50% of the global population, has been recognized as a main risk factor of multiple gastric pathologies, especially non-cardiac gastric cancer. Strongly evidence supports that H.pylori eradication is an effective approach to reduce the incidence of those pathologies.However,Helicobacter pylori eradication is a challenge in patients allergic to penicillin. Therefore, the investigators aim to assess and compare the effectiveness of furazolidone-tetracycline-containing and tinidazole-tetracycline-containing quadruple regimens for the rescue treatment of Helicobacter pylori infection in patients allergic to penicillin.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-70 with H. pylori infection.
* Patients with previous Helicobacter pylori eradication.
* Patients Allergic to Penicillin.

Exclusion Criteria:

* Patients treated with H2-receptor antagonist, PPI, bismuth and antibiotics in the previous 4 weeks.
* Patients with gastrectomy, acute GI bleeding and advanced gastric cancer.
* Patients with known or suspected allergy to study medications.
* Currently pregnant or lactating.
* Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.