cyrilzakka/clinical-trials huggingface dataset:
Efficacy of a Telmisartan/S-Amlodipine on 24-hour BP Control in Hypertensive Patients Inadequately Controlled

To Evaluate the Efficacy of the Timing of the Administration of a Telmisartan/S-Amlodipine (Telminuvo®Tab. 40/2.5mg) on 24-hour BP Control in Hypertensive Patients Inadequately Controlled by Telmisartan Monotherapy

A Multicenter, Prospective, Randomized, Open-label, Phase 4 Trial Designed to Evaluate the Efficacy of the Timing of the Administration of a Telmisartan/S-Amlodipine(Telminuvo®Tab. 40/2.5mg) on 24-hour BP Control in Hypertensive Patients Inadequately Controlled by Telmisartan Monotherapy

Eligibility Criteria:
Inclusion Criteria:

1. More than 20 years in hypertension patient
2. Hypertension is satisfied with the Clinic blood pressure that was measured at the time of screening

   * Treatment-Naive: Clinic Mean sitting diastolic blood pressure ≥ 100mmHg.
   * Treatment-Experienced: Clinic Mean sitting diastolic blood pressure ≥ 90mmHg.
3. Hypertension is satisfied with the Clinic blood pressure that was measured at the time of randomization

   * Clinic Mean sitting diastolic blood pressure ≥ 90mmHg
4. Patient who decided to participate and signed on an informed consent form willingly

Exclusion Criteria:

1. Clinic Mean sitting systolic blood pressure ≥ 180mmHg or Clinic Mean sitting diastolic blood pressure ≥ 115mmHg at the time of Screening and Randomization
2. As night workers who sleep during the day and whose working hours including 00:00 to 04:00
3. Secondary Hypertension
4. Severe heart disease(Heart failure; New York Heart Association(NYHA) class 3, 4) and recent unstable angina or myocardial infarction or valvular heart disease or arrhythmia requiring treatment within the past 3 months
5. Severe cerebrovascular disorders such as cerebral infarction, cerebral hemorrhage within 6 months
6. type 1 diabetes mellitus or Uncontrolled type 2 diabetes mellitus(HbA1c \> 8.0%)
7. Severe or malignant retinopathy
8. Abnormal laboratory test results

   * Aspartate aminotransferase/Alanine aminotransferase \> Upper normal limit X 2
   * Serum creatinine \> Upper normal limit X 2
9. Acute of chronic inflammatory status requiring treatment
10. Need for other antihypertensive drugs during the trial
11. Need for prohibited medication specified in the protocol
12. A history of angioedema with ACE inhibitors or angiotensin-Ⅱ receptor blockers
13. Severe hypersensitivity to amlodipine or telmisartan
14. History of drug or alcohol abuse within 6 months
15. Surgical or medical conditions

    * History of major gastrointestinal surgery
    * History of active inflammatory bowel syndrome within 12 months
    * Abnormal pancreatic functions
    * Gastrointestinal/rectal bleeding
    * Urinary tract obstruction
16. Administration of other Investigational Product within 30 days
17. Pregnant, breast-feeding and childbearing age who don't use adequate contraception
18. History of malignant tumor within 5 years (including leukemia and lymphoma)
19. Another clinical condition in investigator's judgement
Intraoperative Angioembolization in the Management of Pelvic Fracture-Related Hemodynamic Instability

Mortality associated with pelvic fractures resulting from blunt trauma ranges between 6 and 18%. In cases where hemodynamic instability is also present, the mortality rate is significantly greater, and has been reported as high as 60%. There is no general consensus among traumatologists as to the initial management of this complicated subgroup of patients. It is largely debated whether emergent orthopedic fixation or angiographic embolization should be the first line of treatment for pelvic hemorrhage

Pelvic fractures are not usually isolated injuries and it is common that these severely injured patients have concomitant abdominal or thoracic trauma further complicating their management. In situations where multiple sources of hemodynamic instability exist, the need to control hemorrhage quickly becomes imperative. In patients where emergent laparotomy or thoracotomy is indicated, the time until pelvic bleeding sources are addressed is prolonged. Some would argue that the best initial management of the pelvic fractures should be surgical stabilization, while others would support immediate angioembolization of actively bleeding pelvic vessels. The main drawback of angiographic embolization is that it occurs in a separate Angio Suite facility, with concerns being time lost to patient transport and an environment less capable of managing these extremely unstable patients.

At Hershey Medical Center, ten patients suffering pelvic fractures with associated hemodynamic instability between 2003 and 2007 were managed with intraoperative angioembolization (in the Operating Room as opposed to the Angio Suite). Extensive review of published orthopaedic, trauma surgery, and radiology journals yielded no other literature regarding intraoperative angioembolization as a management approach for these patients. Whether or not this approach has been carried out at other medical institutions, it is undoubtedly rare and results have yet to be reported in widely available literature. This novel approach has the potential to stop pelvic bleeding sooner and in a more controlled environment, where surgical stabilization can also be accomplished simultaneously. Statistical analysis and review of these patients has not been done, but may possibly show improvements in survival, shorter length of hospital stay, less time to embolization, and decreased need for supportive measures such as blood or platelet transfusion.

Eligibility Criteria:
Inclusion Criteria:

* Patients with pelvic fractures and associated hemodynamic instability
* Treatment at Hershey Medical Center
* Patient management involved angioembolization in Operating Room

Exclusion Criteria:

* Patients below 18 years of age
Comparing The Effect of Tadalafil 5 mg/Day to Sildenafil 25 mg/Day on Neutrophil-Lymphocyte and Platelet-Lymphocyte Ratios in Erectile Dysfunction Patients; and Comparison of Clinical Response

1- To evaluate the effect of using tadalafil 5mg/day or sildenafil 25mg/day in the treatment on these ratios and its clinical effect in erectile dysfunction patients.

Erectile dysfunction (ED) is an inability to provide adequate erection to initiate or maintain any sexual activity. The ED prevalence in adult males is approximately 20%. Cardiovascular diseases, diabetes mellitus(DM), chronic systemic diseases, smoking and obesity are among the aetiology of ED .In recent years, publications indicating that active inflammatory processes cause ED are increasing. In these studies where neutrophil- lymphocyte (NLR) and platelet-lymphocyte ratios (PLR) were used as signs of inflammation, a significant relationship was found between diseases with these proportions .Neutrophil-to-lymphocyte ratio (NLR) is a simple parameter to assess easily the inflammatory status of a subject. It has proven its usefulness in the stratification of mortality in major cardiac events , as a strong prognostic factor in several types of cancers , or as a predictor and a marker of inflammatory or infectious pathologies (such is pediatric appendicitis) and postoperative complications. Through enhanced production of cytokines and expression of cellular adhesion molecules, the dysfunctional endothelium promotes inflammation within the vascular wall and sets the stage for initiation and progression of atherosclerotic lesions in both penile vasculature and in peripheral and coronary blood vessels. It has been shown that patients with vasculogenic ED have increased inflammatory activation compared to subjects without ED.There are numerous studies suggesting that phosphodiesterase-5(PDE-5) inhibitors, which are the first-line therapy of ED, might be effective in reversing generalized endothelial dysfunction. Chronic treatment restores endothelium-dependent relaxations at various sites of the vascular tree, even up to one week after cessation of the treatment . Previous studies reported a chronic effect of sildenafil and tadalafil on endothelial function and pro-inflammatory markers/mediators including intercellular and vascular cell adhesion molecules-1 (ICAM-1 and VCAM-1, respectively), high sensitivity C-reactive protein (hsCRP), and interleukin-6

Eligibility Criteria:
Inclusion Criteria:

* Male patients with mild,moderate and severe erectile dysfunction.
* Age from 25 to 60 years.

Exclusion Criteria:

* · Severe uncontrolled medical condition(DM,HTN).

  * Patients under treatment with sublingual nitrate .
  * Patients with blood diseases that affect sexual function (Leukaemia).
  * Patients using cytotoxic drugs or immunosuppressive drugs.
  * Single patient.
Study of a Neuroprotective Drug to Limit the Extent of Damage From an Ischemic Stroke

The primary aim of this study is to find out which of 4 different doses of minocycline are safe and well tolerated so that we will know the optimal dose to test in future patients.

Minocycline is a widely used antibiotic and is approved by the Food and Drug Administration (FDA) for treatment of infections and acne. However, doctors do not know whether minocycline will work in stroke patients. Its use in stroke patients is experimental. There is a lot of information from experimental stroke studies in animals that minocycline lessens the damage from a stroke and the animals recover better. Since minocycline is generally a very safe drug in humans and does not have a lot of side effects, investigators at Georgia Health Sciences University (formerly the Medical College of Georgia) believe that it might be a safe and effective drug to improve the outcome in patients with stroke.

Eligibility Criteria:
Inclusion Criteria:

* over 18 years of age
* acute onset focal neurologic deficit consistent with acute ischemic stroke, or computed tomographic scan consistent with acute cerebral ischemia
* onset of symptoms less than 6 hours
* measurable neurologic deficit (National Institutes of Health \[NIH\] Stroke Scale \>/= 1)

Exclusion Criteria:

* allergy to tetracycline antibiotics
* women of child-bearing potential
* known hepatic and/or renal insufficiency
* Thrombocytopenia
* history of intolerance to minocycline
* dizziness at the time of stroke or in the past month (by self-report)
* aphasia likely to interfere with patients ability to report adverse effects
* previous functional disability
* stuporous or comatose
* presence of another serious illness likely to confound the study
* unlikely to be available for 90 day follow-up
* severe stroke (National Institutes of Health \[NIH\] Stroke Scale \>22)
* undergoing an interventional neuro-radiological intervention in first 12 hour
Comparison Between Colloids and Crystalloids on Coagulation and Blood Loss

Infusion of intravenous fluids is mandatory especially in major and prolonged surgeries. However, there is no available optimum ideal type of fluid nor a fixed amount suitable for transfusion but it must be individualized for every patient to minimize the side effects of fluids.

Ringer's lactate as an example of crystalloids, causes a transient hypercoagulable state after its infusion, disappears in less than 6 hours of infusion and the coagulation profile returns to its state before Ringer's.

Voluven (Hydroxyehthyl starch 130/0.4) a colloid causes a hypocoagulable state after its infusion, and its effect is prolonged to more than 6 hours after infusion.

The effects of hydroxyethyl starch are not dose-dependent, but they can be remarkable even with mild to moderate amount of blood dilution applying nearly a restrictive fluid transfusion strategy and a goal-directed fluid therapy mode.

The amount of needed crystalloids is much more than that of colloids to maintain patients hemodynamically stable.

When considering the optimum fluid of choice to achieve hemodynamic stability and the least morbidity, colloids have a theoritical and intuitive advantage. Being composed of molecules \>35 kDa, colloids have traditionally been thought to have greater fluid efficacy (i.e. they remain in the intravascular space for longer ,thus contributing a greater effect on cardiac output) compared with crystalloids. These theoritical benefits of colloids led to their routine use in goal-directed therapy (GDT).

Studies in healthy volunteers have demonstrated that crystalloids tend to expand the intravascular volume by about 20% of the infused volume ;however when physiological endpoints have been used in clinical studies , the fluid efficacy of crystalloids increases up to 60%. This discrepancy may be explained by a number of factors, including the time taken for fluid to equilibrate throughout the extracellular fluid , the vaodilating effect of anethetic-indused hypotension on vascular capacitance, and the impairment of fluid elimination because of the surgical stress response.

While colloid has been the default fluid choice in most GDT studies to date, recent evidence from both the perioperative anesthestic setting and from intensive care have raised concerns that these agents may produce adverse effects on renal function and coagulation . recent studies have sought to compare the use of crystalloid solutions with colloids for GDT.

Eligibility Criteria:
Inclusion Criteria:

* age between 18 to 75 years
* undergoing elective colorectal surgery

Exclusion Criteria:

* refusal by the patient
* patient with cardiac disease
* hepatic disease
* renal disease
* blood disease
* patient on regular anticoagulant drug
DuoTrav APS Versus XALACOM® in Ocular Surface Health

To demonstrate superiority of DuoTrav APS over XALACOM® in Ocular Surface Health in patients with open angle glaucoma or ocular hypertension.


Eligibility Criteria:
Inclusion Criteria:

1. Patients ≥ 18 years of age.
2. Must have a clinical diagnosis of open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component), or ocular hypertension in at least one eye.
3. Must be willing and able to discontinue use of any topical ocular medication other than the study medication for the duration of the study.
4. Must have had IOP controlled with mono-therapy using XALACOM for at least 1 continuous month prior to Visit 1.
5. Women of childbearing potential must meet all specific conditions at Visit 1:

Exclusion Criteria:

1. Any abnormality preventing reliable applanation tonometry in the study eye(s).
2. Presence of any ocular pathology in either eye seen during the slit lamp or fundus exams that may preclude the safe administration of test article or safe participation in this study.
3. Dry eye or KCS which has been, or is currently being, treated with the use of punctal plugs, punctal cautery, Restasis®, or topical ocular corticosteroids.
4. Patients who have undergone keratorefractive ocular laser procedures, corneal surgery or surgery to the corneal surface, within 1 year prior to Visit1
5. Any other ocular laser surgery in either eye within 3 months
6. Patients who have undergone intraocular or extra-ocular surgery, in either eye, within 6 months prior to Visit 1.
7. History of other progressive retinal or optic nerve disease.
8. Severe central visual field loss in either eye based upon the clinical judgment of the investigator.
9. Any history of, or current evidence of, infectious or inflammatory ocular conditions
10. Ocular trauma within 6 months prior to Visit 1 in either eye, as determined by patient history and/or examination.
11. History or evidence of corneal transplant or transplant variant procedures
12. Patients with suspected or diagnosed Sjogren's syndrome.
13. History of or current bronchial asthma, or severe chronic obstructive pulmonary disease
14. History of or current severe, unstable or uncontrolled cardiovascular, hepatic, or renal disease.
15. History of spontaneous or current hypoglycemia or uncontrolled diabetes.
16. History of or current severe allergic rhinitis and bronchial hyper reactivity.
17. Intolerance/hypersensitivity to any component of the medication
18. Use of any systemic medications on a chronic basis that have not been on a stable dosing regimen for at least 30 days prior to Visit 1, or an anticipated change in dosing regimen of medications during the course of the study.
19. Use of ocular medications other than XALACOM® within 7 days
20. Use of corticosteroids within 30 days of Visit 1, or any anticipated use of corticosteroids during the course of the study.
21. Use of contact lenses within 30 days of Visit 1. Concomitant use of contact lenses is also excluded for the duration of the study.
Safety and Feasibility of the ELIOS System in POAG Patients

Evaluation of the safety and effectiveness of the ELIOS System procedure to reduce intraocular pressure (IOP) in adult subjects with mild to moderate primary open-angle glaucoma (POAG)


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of mild to moderate POAG
* Medicated IOP of \<=24 mmHg
* Shaffer angle grade of III or IV
* CD ratio \<=0.8
* At least 45 years old

Exclusion Criteria:

* Closed-angle and secondary glaucomas
* Prior incisional glaucoma surgery, intraocular surgery, or corneal surgery
* Cannot undergo medication washout in the study eye
* Diagnosis of degenerative visual disorders Non-study eye with BCVA worse than 20/80 Known corticosteroid responder Pregnant or nursing women; or women of childbearing potential not using medically acceptable birth control
Computer Aided Detection of Polyps in Colonoscopy

The aim of this study is to evaluate the clinical benefit and safety of using a computer aided detection device, Skout, for real-time polyp detection in colonoscopy procedures with the indication of screening or surveillance. One of the reasons for the development of interval colorectal cancers is polyps missed during colonoscopy. Our hypothesis is that with the aid of Skout, the adenomas detected per colonoscopy will increase, and it is plausible to believe that this increase in detection could reduce the incidence of interval cancers.


Eligibility Criteria:
Inclusion Criteria

Participants will be eligible for this study if they are:

* Undergoing colonoscopy with screening, surveillance, or diagnostic indications.
* Undergoing a procedure by a participating endoscopist.
* Have given informed consent.

Exclusion Criteria

Participants will not be eligible for this study if they:

* Have a history of inflammatory bowel disease.
* Have a history of familial adenomatous polyposis.
* Are under the age of 40.
* Have had a colonoscopy within the previous three (3) years.
* Undergoing diagnostic colonoscopy with high-risk indications including iron deficiency anemia, abnormal CT imaging, unexplained weight loss, Lynch Syndrome, blood in stool or FIT positive test.
* Entered with poor bowel preparation (inadequate for procedure as assessed by the Investigator).
* Use anti-platelet agents or anticoagulants that preclude the removal of polyps during the procedure.
Intensive Longitudinal Assessment of Stress and Stress-related Concepts Across a Behavioral Weight Loss Intervention

Examine the association between variability in individual stress and related concepts with weight loss, physical activity, and sleep across a behavioral weight loss program


Eligibility Criteria:
Inclusion Criteria:

* Enrolled in a KUMC community-based weight loss program centered in a metropolitan area of a Midwest state. Based on this criteria, we will anticipate participants are greater than 18 years of age, and have obesity
* Must own a smart phone and be willing to download the mobile application to receive text messages

Exclusion Criteria:

* Report a current medical condition or treatment for a medical condition that could affect body weight.
* Current psychological condition that is untreated, hospitalization for a psychological condition within the past 12 months, or not being on a stable dose of treatment for at least 6 months.
* Clinically diagnosed depression.
* Is not fluent in writing or speaking the English language.
* Mobility limitations so they are unable to perform physical activity.
* Family member currently enrolled in the study or has a family member that previously participated in the study.
Study to Assess Adverse Events When Ubrogepant Tablets in Combination With Atogepant Tablets Are Used to Treat Adult Participants With Migraine

Migraine is a neurological disease characterized by moderate or severe headache, associated with nausea, vomiting, and/or sensitivity to light and sound. This study will assess the safety and efficacy of the combination use of ubrogepant for the acute treatment of migraine headache in participants taking atogepant once daily for preventive treatment of migraine.

Ubrogepant is an approved drug for the acute treatment of migraine. Atogepant is an approved drug for the preventive treatment of migraine. Approximately 235 adult participants with EM will be enrolled in approximately 45 sites in the United States.

Participants will receive oral atogepant tablets once daily (QD) for 12 weeks followed by continued atogepant treatment with ubrogepant tablets taken as needed for the next 12 weeks.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* At least 1-year history of migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders (ICHD)-3, 2018.
* History of 4 to 14 migraine days per month on average in the 3 months prior to Screening (Visit 1) in the investigator's judgment.

Exclusion Criteria:

- Clinically significant hematologic, endocrine, cardiovascular, cerebrovascular, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.
Combination Therapy With Myo-inositol and Folic Acid Versus Myo-inositol Alone

Previous studies have demonstrated that Myo-inositol is capable of restoring spontaneous ovarian activity, and consequently fertility, in most patients with PCOS. The aim of our study is to investigate the role of folic acid conteined in the inositol preparation. The study group included 50 patients, randomly allocated to subgroup A (myo-inositol 1500 gr) and subgroup B (myo-inositol 2000 gr + folic acid 200 mcg). The investigation include menstrual pattern and hirsutism score evaluation, hormonal assays, oral glucose tolerance test, euglycemic hyperinsulinaemic clamp and lipide profile at baseline and after six months of treatment.


Eligibility Criteria:
Inclusion Criteria:

* women with PCOS diagnosed in accordance with Rotterdam Consensus Conference Criteria 2003
* BMI \> 25 kg/m2
* age 18-35 years

Exclusion Criteria:

* pregnancy
* significant liver or renal impairment
* other hormonal dysfunctions (hypothalamic, pituitary, thyroidal or adrenal causes for the clinical signs)
* neoplasms
* unstable mental illness
* diagnosis of diabetes mellitus or impaired glucose tolerance
* use of drugs able to interfere with gluco-insulinaemic metabolism for at least three months prior entering the study.