cyrilzakka/clinical-trials huggingface dataset:
The Effect and Safety of Different Intensity Anticoagulation Therapy in Elderly Patients With Non-valvular Atrial Fibrillation

Current guidelines recommend standard warfarin anticoagulation international normalized ratio (INR) goal of 2.0-3.0 in adults with non valvular atrial fibrillation (NVAF). The investigators hypothesized that low-intensity warfarin (INR 1.5-2.0) has the same effectiveness and better security in elderly patients (\>75) with NVAF.

Atrial fibrillation is the commonest chronic arrhythmia in clinical practice, especially in octogenarians. Nonvalvular atrial ﬁbrillation increases the risk of ischemic stroke by approximately 5-fold and these strokes result in higher mortality and disability. Warfarin is recommended as ﬁrst line anticoagulation treatment in patients with NVAF who are at moderate or high risk of stroke,while antiplatelet agents, such as aspirin, give a more convenient but less effective alternative in the prevention of ischemic stroke and are recommended in low risk patients.Current guideline about warfarin anticoagulation therapy recommend that target INR value must be maintained between 2.0 and 3.0,which not only reduces the frequency of ischaemic stroke but also its low incidence of major bleeding. However, the current status of anticoagulation therapy for elderly Chinese AF patients, particularly in aged over 80 years, is not clear. The purpose of the present study was to test the hypothesis that an INR target of 1.5-2.0 can provide the same efficacy and better safety as compare with a standard target of 2.0-3.0 in patients over 75 with NVAF.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of atrial fibrillation
2. Echocardiography confirmed a non-valvular heart disease
3. Age≥75 years

Exclusion Criteria:

1. Unable to cooperate with doctors
2. Life expectancy of less than 1 year
3. Rheumatic heart disease or dilated cardiomyopathy
4. History of artificial valve replacement surgery
5. Infectious endocarditis
6. Stroke or transient ischemic attack(TIA) within the last 6 months
7. Previous history of intracranial hemorrhage, gastrointestinal, respiratory or urogenital bleeding
8. Previous intolerance/allergy to warfarin or aspirin
9. Blood pressure greater than 180/110 mmHg
10. Chronic liver dysfunction, alanine aminotransferase above the normal reference value of the upper limit 3 times
11. Chronic renal failure, serum creatinine clearance rate (Ccr) less than 30 ml / min
12. Patient was receiving antiplatelet or anticoagulant therapy due to other reasons
A Study Comparing Duloxetine to Other Antidepressants in the Treatment of Severe Depression

The purpose of this study is to compare duloxetine with other antidepressants in the treatment of severe depression.


Eligibility Criteria:
Inclusion criteria:

* At least 18 years of age
* Have major depression and are currently in a severe depressive episode
* Have a degree of understanding such that patient can communicate with the investigator and study staff
* All females must test negative for pregnancy
* Females of childbearing potential must use reliable method of birth control during the study and for 1 month after taking the last dose of study drug

Exclusion criteria:

* Have not responded to duloxetine for depression in the past
* Have a history of bipolar disorder, a psychotic disorder (such as schizophrenia), a cognitive disorder (such as moderate or severe dementia), or obsessive-compulsive disorder (OCD)
* Are at significant risk for suicide
* Have not responded to 2 or more adequate trials of antidepressant medications during the current depressive episode
* Have a serious, unstable medical condition
* Have a current or recent history of substance abuse or dependence
* Have had electroconvulsive therapy (ECT), transcranial magnetic stimulation (rTMS), or vagus nerve stimulation (VNS) in the past year
* Have started psychotherapy within 6 weeks prior to study entry
* Have a serious medical illness or clinically significant laboratory abnormality that is not stabilized or is anticipated, in the judgment of the investigator, to require hospitalization or use of an excluded medication during the course of the study
Efficacy, Safety and Tolerability of AEB071 Versus Cyclosporine in the Novo Renal Transplant Recipients

This study will assess safety and efficacy of AEB071 combined with everolimus in a CNI-free (calcineurin inhibitor) regimen in renal transplant recipients.


Eligibility Criteria:
Inclusion criteria

* Male and female patients 18 years or older
* Recipients of first kidney transplant from a deceased or living not related donor

Exclusion criteria

* Need for medication prohibited in the study
* Patients with heart disease (own or family history)
* Patients or donor HIV, Hepatitis B (HBsAg) or Hepatitis C (HCV) positive
* Patients with high immunological risks
* Patients with a history of cancer
* Other protocol-defined inclusion/exclusion criteria may apply
Coenzyme Q10 Role in Prevention of Contrast Induced Nephropathy in Acute Coronary Syndrome Patients.

In this study the investigators aim to study the effect of supplementation of CoQ10 in decreasing the incidence of contrast induced acute kidney injury in patients with acute coronary syndrome undergoing coronary angiography.

Patients who fulfilled the inclusion criteria and agreed to participate in the study will be randomly divided into 2 groups using their computer generated random numbers that group a will receive the coenzyme Q10 in addition to the standard preventive measures and group b will receive only the standard preventive measures without the coenzyme Q10.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are 18 years or older.
* ST-elevation myocardial infarction (STEMI).
* Non ST-elevation myocardial infarction( NSTEMI).
* Unstable Angina (UA)

Exclusion Criteria:

* Renal transplant patients.
* Preoperative bleeding .
* Intraoperative bleeding or hypotension.
* Patients taking any nephrotoxic medications
Circulatory Function in Laparoscopic Radical Cystectomy for Bladder Cancer

To optimize the perioperative management of patients undergoing laparoscopic radical cystectomy(LPC) for bladder cancer through observation of perioperative changes of Brain Natriuretic Peptide(BNP), stroke volume variation(SVV), central venous pressure(CVP) and the use of transthoracic echocardiography(TTE).

Long term pneumoperitoneum and steep trendelenburg in LPC for bladder cancer influence perioperative circulatory function, resulting in a series of pathophysiological changes. BNP is of high sensitivity and specificity in the evaluation of cardiac function. SVV and CVP are dynamic and static indices to predict fluid responsiveness. TTE is a good indicator of volume and cardiac function.Thus, we conducted the trial to assess the perioperative circulatory function in patients undergoing LPC. We hypothesized that long term pneumoperitoneum and steep trendelenburg in LPC for bladder cancer would increase perioperative blood volume and influence cardiac function.

Eligibility Criteria:
Inclusion Criteria:

* undergoing laparoscopic radical cystectomy for bladder cancer
* ASA I-II

Exclusion Criteria:

* Cardiac insufficiency
* Hepatic insufficiency
* Renal insufficiency
Tetrandrine Tablets Used in the Treatment of COVID-19

The study is expected to treat patients with mild and severe neo-coronary pneumonia through standard treatment regimens in combination with tetrandrine tablets, thereby reducing the clinical progress of some patients, improving prognosis, reducing the incidence of pulmonary fibrosis during rehabilitation, and improving patients' quality of life.

Since December 2019, a number of cases of pneumonia infected with the new coronavirus have been found in wuhan, hubei province.Has now become a global epidemic of crisis.

After recent frontline anti-epidemic experience, the diagnostic and treatment specifications for new coronary pneumonia have been updated several times. In the latest country, "Specifications for the Diagnosis and Treatment of New Types of Coronary Pneumonia (Trial Version 6)", the traditional Chinese medicines have again emphasized For the treatment of patients, traditional Chinese medicine preparations such as Xuebijing and Qingfei Paidu Decoction have been recommended, but the introduction of anti-fibrosis related drugs is still lacking.Tetrandrine is a traditional Chinese medicine. Previous research has shown that it is an antagonist of calmodulin, has anti-tumor, anti-inflammatory effects, and can effectively inhibit fibroblasts, thereby inhibiting pulmonary fibrosis.The study is expected to treat patients with mild and severe neo-coronary pneumonia through standard treatment regimens in combination with tetrandrine tablets, thereby reducing the clinical progress of some patients, improving prognosis, reducing the incidence of pulmonary fibrosis during rehabilitation, and improving patients' quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Patients with mild and severe cases who have been diagnosed with new coronavirus pneumonia according to the "Pneumonitis Diagnosis and Treatment -
* Plan for New Coronavirus Infection"
* Age 18 to 75 years;
* Sign the informed consent voluntarily.

Exclusion Criteria:

* With active tuberculosis, idiopathic pulmonary fibrosis, bronchial asthma, bronchiectasis, pulmonary embolism, patients with chronic respiratory failure or other severe respiratory disease;
* According to the "pneumonia diagnosis and treatment program for new coronavirus infection" (trial version 6), critically ill patients
* With severe patients with disease of heart head blood-vessel, malignant arrhythmia, unstable angina, acute myocardial infarction and death, cardiac function level 3 and above, stroke, cerebral hemorrhage, etc.);
* With severe liver and kidney diseases (severe liver disease refers to cirrhosis, portal hypertension and varices bleeding, severe kidney disease including dialysis, kidney transplantation);
* Pregnant and lactating women;
* Severe cognitive and mental disorders;
* Clinical investigators who were participating in other interventions within 1 month prior to inclusion
A Study of the Immune Response to Vaccines and Ixekizumab (LY2439821) in Healthy Participants

The purpose of this study is to compare the body's immune response when vaccines are given alone versus when vaccines are given along with the study drug called ixekizumab. The vaccines protect against pneumonia and tetanus. This study will last about 6 weeks with follow-up at 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males and females without compromised immune system
* Have a body mass Index of 18 to 32 kilograms per square meter (kg/m²)

Exclusion Criteria:

* Previously completed or withdrawn from an ixekizumab study or a study investigating interleukin-17 (IL-17) antagonists
* Have participated, within the last 30 days, in a clinical trial involving an investigational product. If the previous investigational product has a long half-life, 3 months or 5 half-lives (whichever is longer) should have passed
* Have known allergy or hypersensitivity to any biologic therapy
* Past vaccination allergy or Arthus-type hypersensitivity
* Received a tetanus toxoid-containing vaccine within the last 5 years
* Severe allergic reaction to Boostrix
* Allergic to latex
* Have been immunized with pneumococcal vaccine
* Known hypogammaglobulinemia
* History of Guillain-Barre Syndrome
* Active infectious disease
* Had a live vaccination within 1 year prior to screening, or intend to have a live vaccination during the course of the study
* Evidence of a significant uncontrolled neuropsychiatric disorder -
* Have a score of 3 on Item 12 of the Quick Inventory of Depressive Symptomatology-Self Report (16 Items) at screening
* Evidence of Human Immunodeficiency Virus infection, Hepatitis C, B
* Had symptomatic herpes zoster within 3 months of screening
* Women who are lactating
Assessment of the Efficacy and Barrier Protection of Two Cosmetic Products

The aim of the study was to assess the long-term efficacy and barrier protection properties of two cosmetic products on the volar forearms of 20 elderly subjects after four weeks of treatment compared to two untreated test areas.


Eligibility Criteria:
Inclusion Criteria:

* Written Informed Consent to participate in the study
* Willingness to actively participate in the study and to come to the scheduled visits
* Female and male (at least 30% male subjects)
* From 50 to 75 years of age, equally distributed

Exclusion Criteria:

* Female subjects: Pregnancy or lactation
* Drug addicts, alcoholics
* AIDS or infectious hepatitis if known to the subjects
* Conditions which exclude a participation or might influence the test reaction/ evaluation
* Participation or being in the waiting period after participation in similar cosmetic and/or pharmaceutical studies
* Active skin disease at the test area
* One of the following serious illnesses that might require regular systemic medication: insulin-dependent diabetes
* Moles, tattoos, scars, irritated skin, hairs, etc. at the test area that could influence the Investigation
A Clinical Study Evaluating the Safety and Efficacy of IDP-115 in Patients With Rosacea

The purpose of this study is to assess the safety and effectiveness of IDP-115 in treating patients with rosacea.


Eligibility Criteria:
Inclusion Criteria:

* Presence of facial rosacea
* Presence of inflammatory lesions

Exclusion Criteria:

* Dermatological conditions of the face that could interfere with clinical evaluations
* Known history of photosensitivity disorders (such as lupus erythematosus or polymorphous light eruption)
* Female subjects who are pregnant, nursing, planning a pregnancy, or become pregnant during the study
Treatment for Giant Cell Arteritis With Tocilizumab and 8 as Compared to 26 Weeks of Prednisone

The GISCO study plans to determine whether 8-week therapy is just as effective as 26-week cortisone therapy for treating giant cell arteritis

* with tocilizumab,
* while using less cortisone.

The aim of this randomized clinical trial investigates whether 1) a shortened GC 8-week regimen is as effective as the current 26-week regimen and 2) associated with less GC exposure when introducing a GC-sparing agent in the treatment of GCA.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with giant cell arteritis
* Start of tocilizumab treatment at baseline as part of routine clinical practice
* Receive ≥ 20 mg/day prednisone (or equivalent) at baseline
* Written informed consent

Exclusion Criteria:

* Treated with any investigational drug of chemical or biologic nature within a minimum of 30 days or 5 half-lives (whichever is longer) prior to the first dose of tocilizumab.
an Educational Program About Abdominal Compartment Syndrome

Early detection of intra-abdominal hypertension is essential to the prevention of abdominal compartment syndrome and requires close surveillance of intra-abdominal hypertension in patients at increased risk. intra-abdominal hypertension measurements are often taken by the bedside nurse, and in some cases, initiation of serial intra-abdominal hypertension monitoring is prompted by critical care nurses.

Measurement of intra-abdominal pressure is simple, inexpensive, safe and accurate method in determining the presence of intra-abdominal hypertension. This measurement can guide patient management. Monitoring intra-abdominal pressure and abdominal per-fusion pressure.

for signs of abdominal compartment syndrome has become an inexpensive and useful diagnostics tool for identifying complications. An integrated approach to screening and monitoring for intra-abdominal hypertension may improve patient outcomes and decrease hospital costs. Due to the high incidence of intra-abdominal hypertension and abdominal compartment syndrome, it is essential for critical care nurses to regularly monitor intra-abdominal pressure and abdominal per-fusion pressure.

Critical care nurses have the ability to identify intra-abdominal hypertension and abdominal compartment syndrome, implement and evaluate management interventions. Nursing practice should be centered on evidence based practice guidelines . Nurses should provide a standard of care in managing patients who are at risk of intra-abdominal hypertension and abdominal compartment syndrome from pre hospital, emergency, operating room and intensive care areas

Eligibility Criteria:
Inclusion Criteria:

* all nurses that have more than one years experience in the trauma ,general and gastrointestinal ICU

Exclusion Criteria:

* nurses less than one year experience
Comparison Study for Bioelectrical Impedance Device to Measure Human Body Composition

The purpose of this study is to determine if the ElectroFluidGraph(tm) (EFG) impedance analyzer is comparable to a predicate device in measuring human body composition.

The purpose of this study is to determine if the ElectroFluidGraph(tm) (EFG) impedance analyzer is comparable to a predicate device in measuring human body composition under normal patient conditions. Specifically, the goal of this study is to compare impedance measurements (R and Xc) determined by using each bioelectrical impedance device and the estimated body compositional estimates \[total body water (TBW); fat-free mass (FFM); and fat mass (FM)\] calculated by using the same prediction equation (models) as the predicate device.

Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals

Exclusion Criteria:

* None
Frequency of Metabolic Syndrome in Down Syndrome Patients

The aim of this study is to assess the frequency of metabolic syndrome in Down syndrome patients because the prevalence of diabetes mellitus and obesity is higher in individuals with Down syndrome than in the general population.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Down syndrome

Exclusion Criteria:

* History of congenital cardiac defects requiring open-heart surgery
* History of gastroenterologic anomalies requiring bowel resection and/or ongoing medical intervention
* History of leukemia or other cancer
* History of hypothyroidism requiring thyroid hormone replacement
Effectiveness of a Psychoeducation Program in Patients With Severe Mental Disorder

Patients with Severe Mental Disorder (SMD) show a life expectancy of 13 to 30 years lower than the general population. Among the factors that determine this expectancy are cardiovascular risk and the metabolic syndrome. The objective of the present study will be to evaluate the effectiveness of a rehabilitative intervention comprinsing a psychopharmacology and psychoeducation program on cardiovascular risk, metabolic syndrome, independency for activities of daily living and psychopathological symptoms.

It will be selected sixty patients diagnosed with SMD from a community Mental Health Unit from Spain. It will be implemented a intervention program consisted of psychopharmacology + psychoeducation on healthy living habits during three months. The patients will be evaluated at the beginning, at three months and at six months follow-up for weight, waist circumference, waist-hip ratio, body mass index, cardiovascular risk, independency and psychopathology.

Eligibility Criteria:
Inclusion Criteria:

* Over 40 years old,
* A body mass index higher than 30
* Psychopathologically stabilized

Exclusion Criteria:

* Cognitive impairment
Study To Evaluate The Effect Of Renal Impairment On The Pharmacokinetics Of PF-04991532

The primary purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of a single oral dose of PF-04991532 in subjects with renal impairment.


Eligibility Criteria:
Inclusion Criteria:

* Stable renal function defined as \<20% difference between two measurements of serum creatinine obtained on two occasions separated by at least 72 hours to 14 days; the second determination must be obtained within the 28-day period prior to the start of study medication administration. CrCl value at Screening (average of two values obtained within two weeks apart before dosing) will be used for study enrollment.
* Body Mass Index (BMI) of 17.5 to 40 kg/m2; and a total body weight \>50 kg (110 lbs).
* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

* Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of nonhormonal contraception as outlined in this protocol from at least 14 days prior to the first dose of study medication.
* Subjects with recent (within the last 6 months) history of myocardial infarction, unstable angina, coronary revascularization, stroke or transient ischemic attack (TIA).
* Subjects with severe heart failure (New York Heart Association Functional Class IV) at Screening.
* Subjects with acute renal disease.
Therapeutic Drug Monitoring Study of Reduced-Dose Efavirenz (400 mg) in Combo Tablet for Patients Receiving Atripla With Viral Suppression in Taiwan

Prospective, Therapeutic Drug Monitoring Study of Reduced-Dose Efavirenz (400 mg) Plus Tenofovir Disoproxil Fumarate (TDF) and Lamivudine in a Fixed-Dose Combination Tablet (Combo) for Patients Receiving Co-Formulated TDF, Emtricitabine and Efavirenz (Atripla) with Viral Suppression in Taiwan

Efavirenz (EFV) is the most widely used non-nucleoside reverse transcriptase inhibitor (NNRTI). The recommended dose of EFV is 600 mg daily; however, a phase II study showed no significant difference in viral suppression rates across the different EFV groups (200 mg, 400 mg, and 600 mg) at 24 weeks. The week 96 analysis of ENCORE 1 study confirmed the durable virological non-inferiority of EFV 400 mg to the standard 600 mg dose when given as initial therapy with tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC). Fewer EFV-related adverse events (AEs) and fewer treatment discontinuations were also observed in the reduced dose group. The efficacy and safety findings provide robust evidence to redefine the EFV dose for HIV treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are receiving co-formulated TDF/ FTC/ EFV (600 mg) and have achieved an undetectable plasma viral load (\<50 copies/mL) for 6 months or longer at screening visit.
* Having C12 EFV of 1 mg/L or greater at screening.
* (C12 EFV will be determined by using blood sample collected 12 ± 1 hour after previous dosing of co-formulated TDF/ FTC/ EFV (600 mg).
* No known treatment failure to regimens containing TDF, 3TC or FTC, plus EFV.
* Infected with HIV harboring no known resistance-associated mutations to EFV, TDF, 3TC or FTC.
* No known allergies to EFV, TDF, 3TC or FTC.
* Aged ≧20 years.
* Calculated creatinine clearance (ClCr) ≥ 50 mL/min (Cockcroft-Gault formula).
* Provision of written informed consent.

Exclusion Criteria:

* The following laboratory values:

  * Absolute neutrophil count (ANC) \<500 cells/μL
  * Hemoglobin \<7.0 g/dL
  * Platelet count \<50,000 cells/μL
  * Serum alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) levels \>5x upper limit of normal (ULN)
* Pregnant women or nursing mothers.
* Active opportunistic or malignant disease not under adequate control.
* Use of immunomodulators within 30 days prior to screening visit.
* Use any of the prohibited medications: bepridil, astemizole, terfenadine, dihydroergotamine, ergometrine, ergotamine, systemic cytotoxic chemotherapy, amodiaquine, pimozide, midazolam, triazolam, cisapride、St John's Wort、 Elbasvir/Grazoprevir and Simeprevir.