cyrilzakka/clinical-trials huggingface dataset:
Efficacy of a Combination of Amlodipine/Valsartan on 24H Blood Pressure Control With One Nocturnal or Diurnal Intake a Day

This study was a multicenter, randomized, PROBE-type (prospective, randomized, open label, blinded end-point) study of 12 weeks duration comprising four visits, carried out in patients with essential arterial hypertension not controlled on four weeks treatment with amlodipine 5 mg alone.


Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years
* Essential uncontrolled or naive hypertensive patients (SBP ≥= 140 mmHG, DBP - \>/=90 mm Hg, or SBP \>= 130 mmHg, DBP \>= 80 mmHg if diabetes or renal impairment) except patients treated with amlodipine, or intolerant of ARBs and/or calcium channel blockers.

Exclusion Criteria:

* Severe hypertension : SBP \>= 180 mmHg, DBP \>= 110mmHg
* Pregnancy
* Allergia to ARBs and/or to calcium channel blockers
* Antihypertensive tritherapy at V1
* History of heart failure, pectoris angina, stroke, myocardial infarction
* Diabetes type I
* Renal impairment
CPR Quality Between Flexible Stretcher and Standard Stretcher in OHCA

This study aims to compare the quality of emergency medical services cardiopulmonary resuscitation between flexible stretcher and standard stretcher during ambulance transport to hospital among out-of-hospital cardiac arrest patients.

Background: Cardiopulmonary resuscitation (CPR) during ambulance transport in Asia has been known to be ineffective for quality and unsafe for emergency medical services(EMS)providers. Small elevators in high rise buildings are the most serious barriers to provide high quality CPR due to too long stretcher cart to enter in the elevators. We developed flexible stretcher cart to be safely used in small elevator through reducing the length of the stretcher. This study aims to compare the quality of EMS CPR between flexible stretcher and standard stretcher during transport to hospital.

Method:

This is a before and after-trial in a metropolis EMS. Study targets are adult out-of-hospital cardiac arrest (OHCA), excluding evident death cases, pregnancy, DNR cases, and too big or too small body size for stretcher cart or mechanical CPR devices. In the before period, the standard stretcher will be used for manual CPR using standard CPR protocol. In the after period, the flexible stretcher will be used with mechanical CPR devices after 3 cycles of standard manual CPR. Individual and Utstein risk factors will be collected. Main outcomes are no-flow fraction (NFF) measured by defibrillators (X-series) and safety will be measured on mechanical error, transportation error, patient injury and EMS provider injury. Sample size were 24 cases for before (12 cases) and after (12 cases) trial from 80% power and 0.05 of alpha error for expecting 20% quality difference (30% NFF inflexible stretcher and 50% NFF in standard stretcher)

Expected impact:

The study will be expected to find the benefit of flexible stretcher cart during CPR in small elevators. This findings will contribute to revise the Asian EMS protocol for improving quality of CPR.

Eligibility Criteria:
Inclusion Criteria:

* All EMS-assessed OHCA in (3-4) selected districts in Seoul
* 18 years or older of age

Exclusion Criteria:

* Do-Not-Resuscitation cases or OHCA occurring in result of terminal diseases
* Signs of evident death (decapitation, evident livor mortis or rigor mortis)
* Pregnant
* Physique too large for mechanical CPR device application
* Chest deformation or injury
* EMS CPR quality not assessed by the defibrillator
* Return of spontaneous circulation (ROSC) before scene departure
* Cardiac arrest cases during transport
Resource Allocation for Alcohol

A total of 150 young adults (ages 21-29) will be randomized to receive a brief alcohol intervention (intended to reduce alcohol-related resource allocation (e.g., time and money spent on alcohol), alcohol consumption, and alcohol related consequences) or an assessment only control condition.

All participants will complete a 3 week monitoring period of daily surveys assessing time spent in various domains, alcohol use, personal goals, and money spent on alcohol and substance-free activities. Those in the intervention condition will receive weekly personalized information summarizing the previous week's resource allocation.

All participants will complete a 1 and 3 month follow up survey. Participants can earn up to $126 for completing all study components.


Eligibility Criteria:
Inclusion Criteria:

* 1)21-29 years old, 2) reside within WA state, 3) report drinking 2+ days per week, on average, in the last six months, 4) report 4+ heavy drinking episodes (4+/5+ for women/men) in the past month,

Exclusion Criteria:

* 1) currently enrolled in a 4-year college, 2) currently in or seeking treatment for alcohol use
Olmesartan in Essential Hypertension

To test the efficacy and safety of olmesartan in patients with essential hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18 (19 if required by local authorities) to 75 years
* Males and females of any race. Female participants must take adequate contraceptive measures (oral contraceptives, I.U.D.), be post-menopausal or surgically sterilized
* Essential hypertension: sitting DBP greater than or equal to 90 and less than 110 mmHg
* Written Informed Consent
* Mentally competent
* Negative pregnancy test in women at a childbearing age at the beginning of the study

Exclusion Criteria:

* Patients with known severe (World Health Organization (WHO) stage III, sitting DBP stable at greater than or equal to 110 mmHg), malignant or secondary hypertension
* Patients who have had a myocardial infarction or percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) within the last 6 months
* Patients with a history or current evidence of congestive heart failure
* Bilateral renal artery stenosis
* Severe renal insufficiency (serum creatinine greater than 200 micro mol/l)
* Severe hepatic impairment or biliary obstruction
Effect of Body Mass on Acyclovir Pharmacokinetics

Studies have shown that different percentages of body fat can alter the way drugs are distributed in the body. This study will use blood samples taken at different time points for patients taking acyclovir to determine if higher body weights affect drug exposure. The information gathered from this study will help understand if patients with higher body weights need a different dosing plan.

Patients receiving acyclovir as standard of care will be enrolled into this study. They will have blood draws once before they take acyclovir and 10 times after they take the acyclovir (over a total of 12 hours). These patients will be in the hospital already and will not need to make additional trips back to have blood drawn. A total of about 4-5 tablespoons of blood will be drawn for this study. 7 obese patients and 7 matched, non-obese patients will be enrolled into this study.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years of age
* Receiving intravenous acyclovir 5 mg/kg (total body weight \[TBW\] for normal weight patients and ideal body weight \[IBW\] for obese patients) as part of their routine care
* Admitted as an inpatient with an expected stay of at least 24 hours
* Weight \> 190% of ideal body weight (IBW) for "obese" patients or weight 80-120% of IBW for matched control patients.

Exclusion Criteria:

* Receipt of acyclovir or similar agents (valacyclovir, ganciclovir, valganciclovir, famciclovir) in the prior 24 hours
* Serum creatinine \> 1.5 mg/dL at time of drug administration
* Hypersensitivity to acyclovir
* Patients requiring ventilator support or vasopressors in the prior 24 hours
* Receipt of probenecid, mycophenolate, tenofovir, or zidovudine in the prior 7 days
* Pregnant or breast-feeding
* Significant anatomical deformities that influence body habitus (i.e. amputation)
* Prior inclusion in this study
Efficacy of Mitomycin C in Endoscopic Dacryocystorhinostomy: A Systematic Review and Meta-Analysis

To assess the efficacy and safety of local application of intraoperative mitomycin C (MMC) at osteotomy site in endoscopic dacryocystorhinostomy(EN-DCR).

Mitomycin C (MMC) is an antineoplastic agent that inhibits the synthesis of DNA, cellular RNA, and protein by inhibiting the synthesis of collagen by fibroblasts. MMC was originally used as a systemic chemotherapeutic agent, it has been widely used in ophthalmic practice both intraoperatively and postoperatively for prevention of pterygium recurrence, enhancing the success rate of glaucoma filtration surgery. Recently, use of MMC has been described in lacrimal drainage surgery. It is postulated that adjunctive use of MMC over the osteotomy site in endoscopic dacryocystorhinostomy(EN-DCR)surgery could inhibit scarring and granulation tissue formation around the osteotomy site or common canaliculus and enhance the success of EN-DCR surgery.

Many controlled trials have investigated adjunctive MMC for primary or revision EN-DCR to augment the surgical success rate, but the results are not completely consistent. To the best of our knowledge, there was no meta-analysis on comparison of success rate of EN-DCR with MMC (MMC group) and endoscopic dacryocystorhinostomy without MMC (control group). Therefore, the aim of this study was to undertake systematic review and meta-analysis to evaluate the efficacy of intraoperative MMC application in EN-DCR surgery and help ophthalmologists to determine whether it is a useful adjuvant in EN-DCR surgery.

Eligibility Criteria:
Inclusion Criteria:

1. comparative studies;
2. adult patients (\> 18 years) with NLDO undergoing primary or revision EN-DCR;
3. all studies included were required to provide the success rates of both MMC and control groups, and the followed up time was more than 6 months.

Exclusion Criteria:

1. studies which did not provide the success rates;
2. studies which included pediatric cases.
Effectiveness of Bariatric Surgery for NAFLD/NASH

This is a prospective, multicenter cohort study, which subjects were obese patients requiring bariatric surgery.

This study aims to explore the the effectiveness of bariatric surgery for NAFLD/NASH with fribrosis, to explore the differences in the effectiveness among sleeve gastrostomy \[SG\], Roux-en-Y gastric bypass \[RYGB\], or one anastomosis gastric bypass \[OAGB\], and to explore the independent effectiveness of bariatric surgery in histological remission of NAFLD/NASH.

The first stage of the cohort was started in 2020, named Base-NAFLD; In May 2024, based on Base-NAFLD, we plan to continue established a secondary cohort, named Base-NASH.


Eligibility Criteria:
Inclusion Criteria:

\[For Base-NAFLD\]

1. Age between 16 and 65 years (all sexes).
2. Diagnosed with obesity according to the World Health Organization criteria for obesity in Asian populations and scheduled for a primary bariatric surgery at the participating centres.
3. Diagnosed with hepatic steatosis preoperatively by radiologic (including ultrasonography, magnetic resonance imaging \[MRI\]-derived proton density fat fraction \[PDFF\]) or pathologic(intraoperative hepatic pathology) examinations.

\[For Base-NASH\]

1. Age between 16 and 65 years (all sexes).
2. Diagnosed with obesity according to the World Health Organization criteria for obesity in Asian populations and scheduled for a primary bariatric surgery at the participating centres.
3. Histologically confirmed NASH with fibrosis:

NAFLD activity score(NAS) ≥4 with at least 1 in each single item and NASH-CRN fibrosis stage ≥F1

Exclusion Criteria:

* any patient who had previously been submitted to any type of bariatric surgery;
* history of excessive drinking: in the past 12 months, the male equivalent of alcohol consumption more than 30g/d, and the female more than 20g/d;
* history of taking amiodarone, methotrexate, tamoxifen, glucocorticoids, etc.；
* history of specific diseases: Gene type 3 hepatitis C virus (HCV) infection, hepatolenticular degeneration, autoimmune hepatitis, total parenteral nutrition, lack of beta lipoproteinemia, congenital lipid atrophy, celiac disease which causing fatty liver, etc.;
* previous major gastrointestinal surgery；
* diagnosed or suspected malignancy；
* poorly controlled significant medical or psychiatric disorders；
* disorders such as a medical history of major pathology;
* can not be able to understand and willing to participate in this registry with signature.
Effect of Bupivacaine Concentration on Ultrasound Guided Pericapsular Group Nerve Block Efficacy in Hip Surgery Patients

Fractures in and around the hip are quite common irrespective of both the young and elderly population groups and are associated with extreme pain.The anterior hip capsule is innervated by articular branches of femoral nerve, obturator nerve and accessory obturator nerve (AON) as reported by previous anatomic studies, suggesting that these nerves should be the main targets for hip analgesia, which can be blocked by Peri-capsular nerve group (PENG).

Fractures in and around the hip are quite common irrespective of both the young and elderly population groups and are associated with extreme pain. A hip fracture is a serious injury, with complications that can be life-threatening and is a common orthopedic emergency in the elderly. Early surgery within 48 h of fracture has shown to decrease the complication and mortality rates.

Spinal anaesthesia is the most common mode of anaesthesia used to fix these fractures. Extreme pain due to fracture does not allow ideal positioning for these procedures. and hence a problem to access the subarachnoid space. Inadequate postoperative analgesia can restrict the limb mobility thereby delaying recovery along with increased consumption of opioids.

Effective perioperative analgesia that reduces the requirement of opioids and its adverse effects is essential in this population.

The anterior hip capsule is innervated by articular branches of femoral nerve, obturator nerve and accessory obturator nerve (AON) as reported by previous anatomic studies, suggesting that these nerves should be the main targets for hip analgesia, which can be blocked by Peri-capsular nerve group (PENG) .

PNB with lower volume and higher concentration of local anesthetic was more efficacious than higher volumes and lower concentrations of local anesthetic of equivalent dose.

Using this information, the investigators will conduct this study to evaluate the efficacy of bupivacaine at three different concentration and doses in equivalent volume used in ultrasound guided PENG block for positioning \& post-operative analgesia.

Eligibility Criteria:
Inclusion Criteria:

* (ASA )classes I and II
* patients of either sex
* above the age of 18 who will undergo hip surgeries( (Dynamic hip screw fixation or hemiarthroplasty)(not older than 2 weeks) with persistent pain and scheduled for surgery under SA with an expected duration of 2.5 hours).

Exclusion Criteria:

* patient's refusal to participate
* any contraindications to SA or peripheral nerve blocks
* history of ischemic heart disease
* patients on opioids for chronic pain
* patients with significant cognitive impairment.
* Patients who have surgery on the hip or spine within 3 months or have no pain while sitting by themselves (resting pain less than 4 on NRS) for SA without any support
Effect of Yoga on Mood and Quality of Life in Patients With Refractory Epilepsy

The purpose of this study is to learn if a structured yoga program can reduce anxiety, improve depression, and improve quality of life in patients with medication resistant epilepsy (MRE).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of unilateral or bilateral temporal lobe epilepsy
* Presence 3 or more seizures per month
* No medical contraindications to yoga
* Willing and able to perform simple non strenuous yoga exercises
* Ability to get on the floor and up again without assistance
* Ambulatory
* Ability to travel to the yoga class twice a week

Exclusion Criteria:

* Any yoga in the last 6 months
* Inability to perform yoga exercises
* History of epilepsy surgery within the last year
* Currently pregnant or less than 6 week postpartum
Ultra-Low Dose Computed Tomography For Diagnosis And Follow-Up Of Patients With Diffuse Parenchymal Lung Disease (DPLD)

The primary intention of this study is to determine the diagnostic performance of ultra-low-dose CT (ULDCT) in diagnosis and follow-up of diffuse parenchymal lung disease (DPLD). We hypothesize that inspiratory and expiratory chest ULDCT has comparable diagnostic yield to standard dose chest High-resolution computed tomography (HRCT) and utility for follow-up of patients with known DPLD. We will study this hypothesis through the following aims:

1. Determine whether inspiratory and expiratory ULDCT are comparable to HRCT in identifying mosaic attenuation due to air-trapping.
2. Determine whether ULDCT is as good as HRCT for follow-up of patients with established DPLD to identify disease progression.


Eligibility Criteria:
Inclusion Criteria:

1. suspected or known DPLD
2. referred to DPLD observation

Exclusion Criteria:

1. other lung related diseases

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Evaluation of Effects of Rosuvastatin 40mg on Myocardial Ischemia in Subjects With Coronary Artery Disease

The purpose of this study is to determine whether treatment with 40mg of Rosuvastatin for 8 weeks will reduce the number of episodes of myocardial ischaemia suffered in subjects with coronary artery disease.


Eligibility Criteria:
Inclusion Criteria:

* Evidence of Coronary arterial disease
* Suffering ischaemic episodes/exercise induced ischaemia
* Not taking any cholesterol lowering medication

Exclusion Criteria:

* Unstable angina or heart attack less than one month before trial entry
* Coronary arterial surgery as defined by protocol
* Uncontrolled hypertension, diabetes, hypothyroidism or laboratory values as defined by the protocol.
Predicting Rupture of AAA by Anatomic and Hemodynamic Markers

The purpose of the study is to investigate imaging findings, which can help us to predict factors contributing to abdominal aortic aneurysm growth and rupture.


Eligibility Criteria:
Inclusion Criteria:

* Individuals between 18 and 80 years old receiving medical care at University of Minnesota Medical Center who have a normal aorta CTA within the previous year
* Or patients with known AAA with growth rate of 0-0.2 cm/year
* Or patients with known AAA with growth rate of greater than 0.5 cm/year.

Exclusion Criteria:

* Subjects with ferromagnetic implants
* Penile implant
* Hip replacement
* History of shrapnel or shot gun injury
* Body mass index ≥ 30
* Cardiac pacemakers
* Severe claustrophobia
* Large tattoos on the torso
A Phase III Study Comparing Two Different Anti-HIV Drug Combinations in HIV-Positive Patients Without Previous Anti-HIV Drug Therapy

The purpose of this study is to see how safe a new protease inhibitor (PI) is and how well it fights HIV infection. A PI is a drug that stops HIV from using healthy cells to make more virus. This study will compare the new PI combination of ABT-378 plus ritonavir (RTV) with another PI, nelfinavir (NFV).

Earlier studies suggest ABT-378/RTV will be just as good as and perhaps better than NFV at fighting HIV infection.

Based on the accumulated studies to date, it is expected that ABT-378/ritonavir will provide efficacy that is at least as good as (or superior to) nelfinavir when used in combination with reverse transcriptase inhibitors.

Patients are equally randomized to one of two treatment arms. In one arm, approximately 330 patients receive ABT-378/ritonavir plus nelfinavir placebo. In the other arm, approximately 330 patients receive nelfinavir plus ABT-378/ritonavir placebo. In both arms, these protease inhibitors are blinded to the investigator, patient, and sponsor. Both arms receive open-label stavudine and lamivudine. Vital sign measurements, physical examinations, ECGs, routine clinical laboratory evaluations, and determinations of antiviral and immunologic activity are performed at intervals throughout the study.

Eligibility Criteria:
Inclusion Criteria

You may be eligible for this trial if you:

* Are HIV positive.
* Have a viral load (level of HIV in your blood) of more than 400 copies/ml.
* Are age 12 or older.
* Agree to practice abstinence or use effective methods of birth control during the study.

Exclusion Criteria

You will not be eligible for this trial if you:

* Have taken anti-HIV drugs for more than 14 days in the past, or if you have ever taken d4T or 3TC.
* Are seriously ill or have an AIDS-related infection.
* Are pregnant or breast-feeding.
* Are taking certain medications.
Effects of Social Skills and Physical Activity Training on Recreational Activities in Youth

The purpose of this study is to examine the effect of social skills training on adolescents physical activity levels. For one week at the beginning and end of the study teens will wear a BioTrainer to measure their activity levels and also wear a pager to communicate the types of activities they are doing throughout the day. For 8 weeks participants will be randomized into one of two groups, a social skills training group or a physical activity group.

The investigators predict that both groups will experience an increase in physical activity and social involvement (decrease time spent alone).


Eligibility Criteria:
Inclusion Criteria:

* Boys and girls ages 12-14
* Youth who encounter problematic relationships with their peers

Exclusion Criteria:

* Youth should have no psychopathology, developmental disabilities, or asthma that would limit participation
* Youth should have no cold or upper respiratory distress or a condition that could influence their activities
* Youth should not be taking medications that could affect their level of activity
Implementation of Practice Standards for ECG Monitoring

The purpose of this study is to test the effect of implementing new practice standards for electrocardiographic (ECG) monitoring on nurses' knowledge and skills, quality of care, and patient outcomes. The investigators hypothesize that increased knowledge and skills of nurses will lead to enhanced quality of care, which will result in improved outcomes for patients.

Despite advances in hospital electrocardiographic (ECG) monitoring technology, monitoring practices are inconsistent and often inadequate. The investigators recently published practice standards for ECG monitoring. The primary purpose of this 5-year multisite randomized clinical trial is to test the effect of implementing these standards on nurses' knowledge and skills, quality of care, and patient outcomes. The investigators expect that increased knowledge and skills of nurses will lead to enhanced quality of care, which will result in improved outcomes for patients. Units serving cardiac patients in 17 hospitals will participate. Hospitals will be randomized to the experimental or control group after baseline measures of knowledge and skills, quality of care, and patient outcomes are obtained. The intervention will include ECG monitoring education and strategies to implement and sustain change. The online education will include 4 modules: essentials of ECG monitoring, arrhythmia monitoring, ischemia monitoring, and QT interval monitoring. The strategies to implement and sustain change in the clinical area include reinforcement of education, incentives, and the designation of "champions" on each unit who will actively promote the implementation of the practice standards.

Eligibility Criteria:
Inclusion Criteria:

* Nurses (and monitor technicians): All nurses (and monitor technicians) working on participating units serving patients with cardiac disease
* Patients: All patients cared for on participating units

Exclusion Criteria:

* Nurses (and monitor technicians): No nurses (or monitor technicians) will be excluded
* Patients: No patients on the participating units will be excluded, even if their primary diagnosis is not cardiac