cyrilzakka/clinical-trials huggingface dataset:
A Study of Changes in Heart Function and Blood Flow in People Receiving Anesthesia

The purpose of this study is to understand changes in heart function (how the heart pumps blood) and blood flow in people who receive general anesthesia during surgery. The researchers are particularly interested in the heart function and blood flow changes in people who experience low blood pressure (hypotension) after receiving anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients ≥ 18 years of age requiring general anesthesia for surgery
* Intubation required for anesthetic management / surgery
* Anticipated prep time before incision of 20 minutes
* Baseline MAP \>70mmHg

Exclusion Criteria:

* History of coronary artery disease
* History of cardiac disease (e.g., HTN, arrythmias, valvular and structural abnormalities)
* History of peripheral artery occlusive disease
* Beta-blocker use
* Anti-hypertensive medication use
* Patients with epidural, spinal, paravertebral, serratus blocks preoperatively
* Patients requiring rapid sequence induction (where intubation occurs concurrently with induction)
* Emergency surgery
Use of Concomitant Medications in HIV-1 Infected Patients in a Large Community Practice in Sydney, Australia

For the majority of patients, management of HIV-1 infection involves effective and well tolerated antiretroviral therapy with simplified pill load and dosing, exemplified by the availability of single tablet regimens (STRs) with single tablet once daily dosing. STR therapy has been shown to improve adherence and reduce hospitalisations (Cohen et al., 2013; Sax et al., 2012).

However, the aging of the HIV cohort in Australia and globally has raised issues of increasing co-morbidities and consequent polypharmacy to manage these (Jansson \& Wilson, 2012; Edelman et al., 2013).

Polypharmacy may not only impact on adherence, but also increases the potential for drug-drug interactions (Holtzman et al., 2013).

Stribild, a highly effective STR, contains cobicistat to boost the levels of the component integrase inhibitor, elvitegravir. Cobicistat does not have antiretroviral activity, but acts by inhibiting Cyp3A4 of the cytochrome p450 metabolic pathway. Other drugs metabolized via this pathway may be affected by this drug-drug interaction (Rogatto et al., 2014). Additionally there is evidence of increased risk of nephrotoxicity with co-administration of tenofovir and non-steroidal anti-inflammatory medication (NSAIDS) (Marcotte et al., 2008).

Data on use of concomitant medications in Australian patients with HIV is sparse. This study aims to determine, in a large caseload community HIV practice, the use of concomitant medications in HIV, patient pill load and dosing frequency, and potential drug-drug interactions with stribild.


Eligibility Criteria:
Inclusion Criteria:

* Documented HIV-1 infection
* Attendance during the study period for at least 2 visits \>3 months and \<12 months apart with measured laboratory virological or immunological markers (either on-site or at a co-management site).

Exclusion Criteria:

* Attendance by patient with HIV infection who does not have laboratory markers of HIV viral load or CD4 count
* Incomplete/inaccessible patient records
Study of SCH 527123 in Subjects With Severe Asthma (Study P05109AM1)

Given the strong inhibition of SCH 527123 on neutrophil migration to sites of inflammation, there is a theoretical reason for its use in patients with severe asthma where neutrophils are thought to play a significant role in the pathophysiology of the disease.


Eligibility Criteria:
Inclusion Criteria:

* Subject must have severe asthma, be at least 18 to less than or equal to 70 years of age, of either sex, and any race.

Exclusion Criteria:

* Subject who has been diagnosed with COPD or any other clinically relevant lung disease, other than asthma (eg, cystic fibrosis, pulmonary fibrosis, bronchiectasis).
Breast Health in Chinese American Women

This four-and-a-half-year study will test the efficacy of viewing a theoretically based and culturally sensitive video followed by group discussion (vs. single viewing) in increasing mammography use. The results of this study will lead cancer control efforts to effectively decrease breast cancer screening disparities experienced by Chinese-America women.

We will conduct a 4.5-year community-based RCT to study the impact of intervention approaches (small-group video discussion vs. single video mode) on mammography used among Chinese immigrant women. The small-group video discussion will be led by trained Chinese community health educators and trained bilingual research staff using a standardized structured protocol at all sites. In the single video mode, we will mail the intervention materials to women to view and/or read at home. We will recruit 974 Chinese women through our strong and well-established Chinese community partnerships in the metropolitan areas of Washington, DC (Lead PI: Dr. Judy Wang, Georgetown University-GU), New York (Site PI: Dr. Grace Ma at Temple University), and southern California (Site PI: Dr. Annette Maxwell, University of California, Los Angeles-UCLA). Participants' eligibility are listed under "eligibility criteria". We will not enroll US-born Chinese women as they are least likely to face cultural and language barriers to mammography and less likely to engage in our small-group discussion, which will be conducted in Chinese languages. Also, we will not enroll short-term visitors as our study involves four interviews over a 2-year period.

Eligibility Criteria:
Inclusion Criteria:

1. First generation Chinese women
2. Aged 42 and older
3. Have not had a mammogram in the past 2 years
4. Have never had breast cancer
5. Lived in the metropolitan DC, southern CA, and NY suburb; AND
6. Have no mammography screening scheduled in the next 6 month from time of enrollment

Exclusion Criteria:

1. Short-term visitors
2. US-born Chinese Americans
Effect of Virtual Reality Glasses Use During Episiotomy Repair Related

H1-1: Watching video with virtual reality glasses during episiotomy repair reduces the level of pain.

H1-2 Watching video with virtual reality glasses during episiotomy repair reduces the level of anxiety.

H1-3: Watching video with virtual reality glasses during episiotomy repair increases the level of satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* 18 years and over,

  * Able to speak Turkish and express himself in Turkish,
  * There is no visual or hearing impairment,
  * Being open to communication, spiritually and mentally healthy,
  * 37- 42 weeks of gestation
  * Single pregnancy,
  * Primiparity,
  * Vaginal delivery,
  * Vertexpresentation
  * Media lateral episiotomy,
  * Uncomplicated newborn
  * Newborns between 2500 and 4000 g.
  * Those with episiotomy between 4-8 cm

Exclusion Criteria:

* Presence of obstetric or non-obstetric complications,
* Presence of bleeding requiring urgent measures,
* Administration of sedative drugs before and during episiotomy repair, spinal anesthesia, epidural anesthesia, pudendal block (except for local infiltration of the perineum),
* Lacerations other than episiotomy (anal sphincter injury or Grade 3 or 4 tear),
* Instrument delivery (with vacuum or forceps),
* Postpartum complications in newborns,
* Chronic disease (diabetes mellitus, thyroid disease and hypertension),
* Having a psychiatric diagnosis
Objective Evaluation of Postoperative Positioning in Macular Hole Surgery

The macular hole formation takes place in the centre of the retina. A closure of the macular hole is believed to take place if the central retinal area is kept dry in the postoperative period. Therefore the eye is filled with a gas mix and the patients are urged to avoid the supine position in the first postoperative days. The investigators have developed a positioning measuring device which can measure the extent of supine positioning time. Patients are to carry the positioning measuring device during the first postoperative 24 hours. Hereby the investigators search new knowledge concerning patients compliance and its relation to macular hole closure.


Eligibility Criteria:
Inclusion Criteria:

* Primary macular hole
* Duration less than 24 months
* Informed consent

Exclusion Criteria:

* Secondary macular hole i.e. trauma, excessive myopia (more than 6 dioptres)
* Previous vitreomacular surgery
* Age under 18 years
* Unable to sign
Once-daily Oral Direct Factor Xa Inhibitor BAY59-7939 in Patients With Acute Symptomatic Deep-vein Thrombosis

The purpose of this study is to determine the optimal dose of BAY 59-7939 and to compare the safety and effectiveness of this new drug with the standard way of treatment of deep vein thrombosis (heparin infusion plus one of the vitamin K antagonists), taking into account new events of thrombosis and pulmonary embolism and bleeding risk.

Within the U.S., Johnson \& Johnson is sponsor.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed acute symptomatic DVT, i.e. proximal or extensive calf-vein thrombosis involving at least the upper third part of the calf veins, without concomitant symptomatic PE
* Written informed consent

Exclusion Criteria:

* Legal lower age limitations (country specific)
* Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT
* Other indication for VKA than PE/DVT
* More than 36 hours pre-randomization treatment with therapeutic dosages of (LMW) heparin or more than a single dose of VKA prior to randomization
* Participation in another pharmacotherapeutic study within the prior 30 days
* Creatinine clearance \< 30 mL/min, impaired liver function (transaminases \> 2 x ULN), or bacterial endocarditis
* Life expectancy \< 3 months
* Active bleeding or high risk for bleeding contraindicating treatment with (LMW) heparin
* Uncontrolled hypertension: systolic blood pressure \> 200 mmHg and diastolic blood pressure \> 110 mmHg
* Pregnancy or childbearing potential without proper contraceptive measures
* Any other contraindication listed in the labeling of warfarin, acenocoumarol, phenprocoumon, fluindione, UFH, enoxaparin, or tinzaparin
* Systemic treatment with azole compounds or other strong CYP3A4 inhibitors (e.g. ketoconazole, fluconazol, itraconazole, HIV protease inhibitors) within 4 days prior to randomization and during the study
Preservative-Free MK2452 (Tafluprost) for Open-Angle Glaucoma/Ocular Hypertension (MK2452-001)(COMPLETED)

This study was to compare the safety and efficacy of the preservative-free formulation of 0.0015% MK2452 (tafluprost) and preservative-free 0.5% timolol maleate in patients with open-angle glaucoma and ocular hypertension. This study was to demonstrate that the preservative-free formulation of 0.0015% tafluprost is non-inferior to preservative-free 0.5% timolol maleate.


Eligibility Criteria:
Inclusion Criteria:

* Patient has been diagnosed with primary open-angle glaucoma, pigmentary glaucoma, capsular glaucoma/pseudoexfoliation, or ocular hypertension
* Patient has a mean (or median) IOP of \>=23 and =\<36 in at least one eye at the 0800 hours time point at the Baseline Visit.
* Patient has \<5 mmHg difference in mean (or median) IOP between eyes at each time point (0800 hours, 1000 hours, and 1600 hours) at Baseline.
* Patient is currently using a prescribed ocular hypotensive medication and has been on a stable dose for 30 days prior to screening, or patient is drug-naive (those who have never used or who have not used ocular hypotensive medication for at least 4 weeks prior to screening)
* Patient is able to safely discontinue current ocular hypotensive medication during up to the 4-week washout period
* Patient has vision corrected to 20/80 or better in each eye
* Patient is willing and able to avoid wearing contact lenses from 4 weeks prior to dosing through 24 hour after final dosing
* Patient is willing and able to self-administer or has an able person available on a daily basis to assist with administration of study medications
* Patient is not pregnant and not planning to become pregnant during the study
* Patient is male or female ≥18 of age on the day of signing the informed consent

Exclusion Criteria:

* Patient is unable to use study medication in the affected eye(s)
* Patient has a history of inflammatory ocular surface disease or anterior or posterior uveitis in either eye
* Patient has a history of retinal detachment, diabetic retinopathy, or other progressive retinal disease
* Patient has experienced significant visual field loss within the last year
* Patient has had intraocular surgery in either eye in the last 4 months
* Patient has a history of glaucoma surgery or refractive surgery in either eye
* Patient is currently taking two or more anti-glaucoma medications (except Cosopt™ or its generic formulation)
* Patient has previously used tafluprost
* Patient has a history of cardiovascular disorder within 6 months prior to screening
* Patient has a history of bronchial asthma, wheezing, pneumonia, COPD, other pulmonary disease, or abnormal chest x-ray
* Patient has a mean (or median) IOP \>36 mmHg in either eye at the Screening Visit or at any time point (0800 hours, 1000 hours, and 1600 hours) of the Baseline Visit.
High-Volume Vs Low-Volume Preparation in Emergency Department

The primary endpoint of this study was to compare the intestinal cleansing of patients with LGIB requiring colonoscopy, prepared with High-Volume or with Low-Volume who have to perform colonoscopy, directly from the ED. The intestinal cleansing was evaluated with the standardized Boston Bowel Preparation Scale (BBPS).

The secondary endpoint was to evaluate the tolerability and compliance of patients prepared with High-Volume in comparison to Low-Volume in the ED.


Eligibility Criteria:
Inclusion Criteria:

* males or females
* \> 18 years and \<85 years,
* hemodynamically stable,
* able to sign informed consent
* requiring colonoscopy
* anemia (loss of at least 2 g/dl of Hb) with or without active bleeding

Exclusion Criteria:

* suspected or confirmed pregnancy,
* hemodynamically unstable patients,
* patients unable to swallow or with known or suspected gastrointestinal obstruction or perforation,
* toxic megacolon,
* major colonic resection,
* heart failure (Class III or IV NYHA),
* severe liver failure,
* end-stage renal disease
Effect of Alkali Therapy on Vascular and Graft Function in Kidney Transplant Recipients

Lower serum bicarbonate levels, even within the normal laboratory range, in kidney transplant recipients (KTRs) are associated with an increased risk of graft loss, cardiovascular events and mortality. Because acid retention is common in KTRs, it is plausible that alkali therapy in KTRs may also result in improved vascular and graft function. The investigators will perform a randomized, double-blinded, placebo-controlled, 12 month study in 120 KTRs to examine the effect of sodium bicarbonate therapy on surrogate markers of CVD and graft function. The overall hypothesis is that treatment with bicarbonate will improve indicators of vascular and graft function in KTRs by decreasing complement activation.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years
* Serum bicarbonate 16-24 mEq/L on 2 separate measurements (at least 1 day apart)
* Kidney transplant received 1 year prior to randomization
* eGFR ≥ 45 ml/min/1.73m2 by CKD-EPI equation
* Blood pressure \<130/80 mm Hg prior to randomization
* BMI \< 40 kg/m2 (FMD measurements can be inaccurate in severely obese patients).
* Able to provide consent
* Immunosuppression regimen consisting of tacrolimus, mycophenolate mofetil and prednisone (95% of patients at University of Colorado are on this regimen)
* Stable immunosuppression regimen for at least three months prior to randomization
* Stable anti-hypertensive regimen for at least one month prior to randomization
* Not taking medications that interact with agents administered during experimental sessions (e.g. sildenafil interacts with nitroglycerin).

Exclusion Criteria:

* Significant comorbid conditions that lead the investigator to conclude that life expectancy is less than 1 year
* Use of chronic daily oral alkali within the last 3 months (including sodium bicarbonate, calcium carbonate or baking soda)
* Uncontrolled hypertension
* Serum potassium \< 3.3 or ≥ 5.5 mEq/L at screening
* New York Heart Association Class 3 or 4 heart failure symptoms, known EF ≤30%, or hospital admission for heart failure within the past 3 months
* Nephrotic range proteinuria (urine complement activation fragment measurements may not be accurate with severe proteinuria)
* Factors judged to limit adherence to interventions
* Current participation in another research study
* Pregnancy or planning to become pregnant or currently breastfeeding
* Chronic use of supplemental oxygen
* Use of anticoagulants
AquaLase Capsule Wash for Pediatric Eyes

To determine whether AquaLase capsule wash reduces posterior capsule opacification (PCO) in pediatric eyes.

Dramatic advances have occurred in the treatment of childhood cataracts in the last 10 years. Intraocular lens (IOL) implantation has been universally accepted as the standard of care for most children undergoing cataract surgery beyond infancy. Despite advances in cataract surgery in children, PCO remained a significant complication following pediatric cataract surgery. In addition to being visually disturbing, it also induces amblyopia in children and if not treated at the earliest, irreversible visual changes may occur. The younger the child, the more acute is the problem: PCO occurs faster and the effect of amblyopia is more pronounced.

To prevent opacification of the visual axis after cataract surgery, primary posterior capsulectomy and vitrectomy are routinely needed while managing pediatric cataract. This surgical step is not routinely used in adult cataract surgery, where we prefer an intact posterior capsule. Researchers are constantly trying to find a way to avoid the need for invasive procedures like posterior capsulectomy and vitrectomy for pediatric eyes. Use of AquaLase technology has shown some capability in cleaning the capsular bag during cataract surgery. Observations of this include anecdotal observation from users. AquaLase for cataract removal with the Infiniti Vision System has been used since 2003, is registered, and the FDA clearance is 510(k) number K980292. AquaLase uses pulses of warmed balanced salt solution to gently emulsify and facilitate aspiration of cataracts. The device under evaluation falls under the same FDA clearance. The unique aspect is the application tip which is intended to allow more thorough capsular bag cleaning or removal of more residual lens material than is currently being achieved. The energy source, controls, and materials are all identical to the currently marketed product. The difference is in the geometry of the distal most end of the application tip.

Eligibility Criteria:
Inclusion Criteria:

* Bilateral cataract in a child aged 6-15 years old
* Informed consent from the parents/legal guardian.

Exclusion Criteria:

* traumatic cataract
* fellow eye - visually not significant cataract
* fellow eye surgery not scheduled within 3-month period after first eye surgery
* dense posterior capsule plaque
* preexisting posterior capsule defect
* subluxated cataract
* high myopia (defined as axial length \>24 mm)
* child with multiple disability where it may not be feasible to perform YAG laser capsulotomy in the office, if needed
* Participants with a strong likelihood of non-adherence (difficulties in adhering to follow-up schedule due to geographic distance from clinical center)
Preoperative Transhepatic Arterial Chemotherapy (TAC) in the Treatment of Liver Metastasis of Resectable Colorectal Cancer

The purpose of this study is to investigate whether preoperative TAC is able to improve progression free survival and overall survival in patients receiving liver metastasis resection of colorectal cancer.

We administered TAC(oxaliplatin,FUDR and MMC) 7 days before liver metastasis resection of colorectal cancer. The study endpoints were progression free survival and overall survival as evaluated by intent-to-treat analysis.

Eligibility Criteria:
Inclusion Criteria:

* age \<= 75 years
* resectable liver metastasis
* remnant liver volume \>= 70%
* without other organ metastasis or peritoneum metastasis
* without contradiction of cardiac and pulmonary diseases

Exclusion Criteria:

* age \> 75 years
* unresectable liver metastasis
* remnant liver volume \< 50%
* with other organ metastasis or peritoneum metastasis
* with contradiction of cardiac and pulmonary diseases
The Impact of a Customized Informative Video Prior to Induction of Labor on Anxiety Relieve.

To determine whether watching a personalized video prior to medically indicated labor induction among term parturients reduces anxiety levels according to the STAI questionnaire, compared to a standard counselling.

The prevalence of induction of labor (IOL) has increased over the last decade, reaching between 15 to 30% of all deliveries in developed countries. IOL is commonly carried out using an extra-amniotic balloon (mechanical induction) or prostaglandins (pharmacological induction). Medical indications for IOL include maternal and fetal indications, where inducing labor results in improved maternal and neonatal outcomes compared with conservative management.

The process of labor induction can be associated with anxiety, especially in women undergoing IOL for the first time. Previous studies have focused on IOL success, examining the vaginal delivery rate or the time to delivery. Only a few studies have addressed the discomfort and anxiety that might accompany the procedures of IOL. A previous study from Australia found that women undergoing IOL wished to be presented with choice options, and receive more information about the process and its possible risks. A Swedish study found that the birth experience of women who underwent labor induction was less positive than that of women who gave birth spontaneously, with the former expressing greater concern for the baby's health.

Personalized video technology allows for the creation of a customized instructional videos, that may help reduce anxiety and decrease the element of uncertainty regarding IOL process and the expected fetal health. A possible advantage of this technology is that it may better engage patients and explain the medial intervention in a simple and clear manner. Many studies have examined the effect of presenting video clips, whether standardized or personalized, before medical procedures. These studies have shown significant effectiveness in improving adherence and strengthening the individual's commitment to the procedure, as well as creating a deeper understanding of the future events when using this technology. This technology is a simple method that does not involve pharmacological or invasive medical interventions to alleviate pain and anxiety.

The aim of this study is to examine whether using a personalized video reduces patients level of anxiety during induction of labor.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women, aged 18-45, undergoing medical IOL at term.
* Unfavorable cervix (BISHOP score \<6).
* Cervical ripening with either prostaglandin E2 (PGE2) tablets or extra-amniotic balloon (EAB).
* Provided consent to participate in the study.
* No language barrier preventing completion of the questionnaire.

Exclusion Criteria:

* Sensitivity to PGE2.
* Preterm labor.
* Premature rupture of membranes.
* Stillbirth.
* Elective pregnancy termination.