cyrilzakka/clinical-trials huggingface dataset:
Supercharged TRAM Evaluation in Cervical Esophagogastroplasty After Esophagectomy

Esophagectomy has high rates of morbidity and mortality, in many cases due to esophagus reconstruction. Anastomotic leakage and fistula are the main esophagectomy complications. Many studies underwent to investigate the cause for anastomotic leakage after esophagectomy, however none of them conclude it is related to surgery or suture technique. However, it seems to be triggered by the ischemia caused after stomach mobilization to esophagus reconstruction, or even tension in the anastomosis.

Considering the post esophagectomy with gastroplasty high morbidity and mortality rates, strategies to create a new vascularization source and decrease anastomotic leakage rates is important. In this study researchers will evaluate whether a TRAM flap transfer supercharged is effective on decrease morbidity related to anastomosis ischemia in patients undergoing esophagectomy.

The transfer of muscle parts is one of the main reconstruction techniques used in plastic surgery. Transverse rectus abdominis myocutaneous (TRAM) flap transfers are very considered due to high quality results, wide application in many cases, and small number of reviews in long term.

Beegle, in 1991 published a new technique of using TRAM supercharged in which microsurgical anastomosis are used between TRAM's unipedicled gastroepiploic deep artery and veins and thoracic branches and vessels, such as axillary and thoracodorsal vessels.

Looking for recover tissue blood perfusion and decrease morbidity rates associated with anastomosis ischemia, some studies showed large intestine or jejunum interposition plus an additional blood supply through venous and arterial anastomosis - colon or jejunum supercharged is effective. The isoperistaltic supercharged colon interposition was a good option to rebuild big esophagus parts in which stomach was not available.

Considering the post esophagectomy with gastroplasty high morbidity and mortality rates, strategies to create a new vascularization source and decrease anastomotic leakage rates is important. This is a single-institution, randomized clinical trial with participants recruited in the digestive system surgery clinic, at the Instituto do Câncer do Estado de São Paulo (ICESP). Patients will be randomized to conventional esophagectomy or TRAM supercharged esophagectomy, and researchers will evaluate post-operatory complications in both groups.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of esophageal malignancy cancer;
* Ability to understand and collaborate during treatment;

Exclusion Criteria:

* Previous gastrectomy;
* Previous abdominal surgery with risk of altering stomach vascularization;
* Previous head and neck surgery with risk of alteration of cervical vessels.
Iron Status of Women and Young Children in the United States

This analysis describes the distribution of TBI and the prevalence of iron deficiency (ID) and iron deficiency anemia (IDA) among toddlers, non-pregnant women, and pregnant women.

Background: Total body iron stores (TBI), which are calculated from serum ferritin (SF) and soluble transferrin receptor (sTfR) concentrations, can be used to assess the iron status of populations in the United States.

Objective: This analysis describes the distribution of TBI and the prevalence of iron deficiency (ID) and iron deficiency anemia (IDA) among toddlers, non-pregnant women, and pregnant women.

Design: Investigators analyzed data from NHANES; toddlers aged 12-23 mo (NHANES 2003-2010), non-pregnant women aged 15-49 y (NHANES 2007-2010), and pregnant women aged 12-49 y (NHANES 1999-2010). Investigators used SAS survey procedures to plot distributions of TBI and produce prevalence estimates of ID and IDA for each target population. All analyses were weighted to account for the complex survey design

Eligibility Criteria:
Included:

* Children ages 12-23 months and Women ages 12-49 years
* Those who completed the MEC

Excluded:

- Those missing data on iron biomarkers
Comparing a Home Vision Self-Assessment Test to Office-Based Snellen Visual Acuity in Myopic Children

This study aims to compare a home vision self-assessment test to office-based Snellen visual acuity in myopic children.

Visual impairment is an important public health issue worldwide, with a heavy socioeconomic burden. More than 400 million people globally have mild to severe visual impairment.

Visual acuity (VA) screening is the most basic part of ophthalmic examination. Home vision screening tests have become an important way to obtain a measure of an individual's VA without an office-based clinic visit. Knowing a patient's VA can help ophthalmologists remotely triage acute calls, monitor visual recovery after medical or surgical interventions, and ensure visual stability in follow-up telemedicine visits.

Home vision screening tests have become an important way to obtain a measure of an individual's VA without an office-based clinic visit. Numerous electronic home vision assessment tools exist, but many of these are used through applications on mobile or tablet devices.

Eligibility Criteria:
Inclusion Criteria:

* Age ≤ 18 years.
* Both sexes.
* Patients who completed the home visual acuity test and have a subsequent office-based visual acuity test.

Exclusion Criteria:

* Last in-office visual acuity of 20/125 or worse in both eyes (to allow for a buffer of at least 2 lines of vision from the upper limit of 20/200 on the home vision assessment).
* Lack of access to MyChart.
* History of keratopathy, cataract, glaucoma, retinal detachment, neuro-ophthalmic disease, or other eye diseases.
* History of ophthalmic surgery or trauma.
* History of systemic diseases.
* Severe psychological or psychiatric diseases.
Moxifloxacin in the Prevention of Bacteremia After High-dose Chemotherapy and Transplantation of Peripheral Stem Cells

This study investigates whether the prophylactic use of moxifloxacin during high-dose chemotherapy followed by autologous stem cell transplantation reduces the incidence of clinically significant bacteremia.

Further investigations include time to occurrence of fever, duration of fever, overall survival and antibiotic sensitivity of blood isolates.

Because fluoroquinolones have broad antimicrobial coverage, bactericidal activity, high tissue concentrations, oral bioavailability and adequate tolerability and safety profiles, they are ideal candidates as antibacterial prophylaxis in cancer patients. Randomized trials investigating the effect of an antibiotic prophylaxis on patients with intermediate neutropenia have recently been conducted with levofloxacin. The influence of moxifloxacin on the incidence of bacteremia in patients undergoing autologous hematopoetic stem cell transplantation has not been investigated. Moxifloxacin may be another promising alternative, covering a broader spectrum of gram-positive and anaerobic bacteria than first- or secondary generation fluoroquinolones and for instance it is an agent administered only once daily, thus optimizing compliance, a crucial issue in prophylaxis.

Eligibility Criteria:
Inclusion Criteria:

* High-dose chemotherapy followed by peripheral autologous stem cell transplantation
* Underlying disease: Hodgkin Disease, non-Hodgkin-lymphoma, multiple myeloma or solid tumor

Exclusion Criteria:

* Allogenic stem cell transplantation
* Aplastic anemia
* Antibiotic treatment within seven days prior to randomization
* Signs and symptoms of current infection
Safety and Efficacy Study of Transplantation of EPCs to Treat Idiopathic Pulmonary Arterial Hypertension

Experimental data suggest that transplantation of endothelial progenitor cells (EPCs) attenuates monocrotaline-induced pulmonary hypertension in rats and dogs. In addition, clinical studies suggest that autogolous progenitor cells transplantation is feasible and safe in patients with ischemic disease. This study will investigate the feasibility, safety, and initial clinical outcome of intravenous infusion of autologous EPCs in patients with idiopathic pulmonary arterial hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of idiopathic pulmonary arterial hypertension

  1. in New York Heart Association (NYHA) functional class II to III
  2. a mean pulmonary artery pressure more than 30 mmHg on right heart catheterization
  3. the ability to walk ≥50 m during a standardized 6-minute walk test

Exclusion Criteria:

* Pulmonary hypertension as a result of heart disease, pulmonary disease, sleep-associated disorders, chronic thromboembolic disease, autoimmune or collagen vascular disease, HIV infection, liver disease, NYHA functional class IV, major bleeding requiring blood transfusion, diabetes, renal dysfunction, and evidence for malignant diseases were excluded
PRevalence of Obstructive Sleep apnoEa and Reduction of Promoters in AF

This study aims to identify how many patients who have atrial fibrillation, also have sleep apnoea. This is important because sleep apnoea can be a trigger to atrial fibrillation and it can be corrected with a simple intervention. Therefore it is important to understand its prevalence (how many patients with atrial fibrillation are affected by it). Also, obesity and sleep disorders are often associated, therefore the evolution of atrial fibrillation is studied in patients who also have obesity and have lost weight compared with patients who did not loose any weight or are not obese. As medications or therapy are not changed, this is an observational study.


Eligibility Criteria:
Inclusion Criteria primary outcome:

* 1 episode of atrial fibrillation in the previous year

Inclusion Criteria secondary outcome:

* BMI \> o = 27Kg/m2
* AHI \>30 o con 15\<AHI\<30 associated with other symptoms (sleeplessness, uncontrolled hypertension and cerebral events)

Exclusion Criteria:

* Ejection Fraction \<50%
* HFpEF not related to atrial fibrillation.
* coronary artery disease
* valvular cardiomyopathy
* patient already in treatment for sleep apnoea
* hyperthyroidism
Evaluation of Nocturnal Hypertension and Correlation With Target-Organ Damage

The aim of this study is to evaluate nocturnal hypertension with 24-hour ambulatory blood pressure and home blood pressure (BP) measurements through a) comparison of mean BP and nocturnal dipping assessed with the two methods, b) correlation of those parameters with parameters of target-organ damage and c) comparison of the potential of the two methods to define non-dippers.

It is well known that blood pressure (BP) exhibits diurnal variation. Nocturnal fall of BP normally exceeds 10%. Subjects with such fall of BP during sleep are classified as "dippers" and those with a nocturnal fall of BP less than 10% are classified as "non-dippers". Non-dippers are exposed to a greater cardiovascular risk. To date dipping status is defined with 24-hour ambulatory BP monitoring (ABPM). Many studies have shown that Home BP monitoring (HBPM) can be an alternative to daytime ambulatory BP monitoring and it exhibits similar correlation to markers of hypertension target-organ-damage (TOD). Nocturnal hypertension shows closer correlation with TOD, than daytime hypertension. In this study patients will be provided with a new-technology, reliable oscillometric device for HBPM, equipped with a modified algorithm, which allows scheduled automated BP measurements during sleep (Microlife WatchBP Home Nocturnal). Duplicate morning and evening BP measurements with one-minute interval will be performed by the patient sitting during seven working days. Afterwards a 24-hour ABPM will be performed, using Microlife WatchBP O3 oscillometric device, with a 20-minute interval between measurements. This order may be reversed according to the wish of the patient and devices' availability. Participants will visit site 3 times. Office blood pressure will be measured during two visits. Triplicate measurements with Microlife WatchBP Home Nocturnal will be performed at the sitting position.

TOD will be assessed with:

* cardiac triplex (LVMI)
* carotid triplex (ΙΜΤ)
* pulse wave velocity.
* Albumin/creatinine ratio measured in morning urine sample.

Eligibility Criteria:
Inclusion Criteria:

* Mean 24-hour Systolic BP (SBP) \>130 mmHg and/or Mean 24-hour Diastolic BP (DBP) \>80 mmHg.
* Patients physically and mentally capable of self-measuring BP at home.
* Written informed consent.

Exclusion Criteria:

* Sustained arrhythmia.
* Pregnancy.
* Symptomatic cardiovascular disease.
* Any other serious illness (cardiac, renal, or malignancy).
Cognitive Decline and Underlying Mechanisms in Asymptomatic Intracranial Artery Stenosis Patients

The purpose of this study is to explore the mechanism of cognitive impairment in patients with asymptomatic intracranial atherosclerotic stenosis(ICAS),and to examine the natural history and the pathogenesis of asymptomatic ICAS.

All participants underwent a medical evaluation that included routine laboratory studies before and after 1- and 2-years follow-up. Upon meeting the inclusion criteria and providing informed consent, each participant will complete a battery measure of neuropsychological tests, blood sample collection, and magnetic resonance imaging scan after enrollment and after 1- and 2-years follow-up.

About 100 participants were included in this study. A series of neuropsychological tests were obtained by a trained investigator to assess. The tests include the evaluation of global cognitive function and multiple individual cognitive domains. The various tasks and questionnaires to measure cognition function including Montreal Cognitive Assessment(MoCA), Mini Mental State Examination(MMSE), Chinese Auditory Verbal Learning Test(CAVLT), Digital Span Test(DST), Symbol digital modalities test(SDMT), Stroop color test(Stroop test), Color trail test(CTT), Rey-Osterrieth Complex Figure(ROCF), Judgment of Line Orientation (JoLO), Verbal Fluency Test(VFT), Boston Naming Test (BNT) , Lateralized attention network test(LANT) etc, at the same time, the investigators also pay attention to the evaluation of participants' emotions by Hamilton Anxiety Scale(HAMA),Hamilton Depression Scale(HAMD). Furthermore, the memory as the primary outcome measure, this study focused on the immediate memory, delayed memory and recognition memory of patients with asymptomatic ICAS. Blood sample will be collected for biological multiomics research. The patients will receive a magnetic resonance imaging scan in multi-modalities.

After 1 and 2 years follow-up,the participants will be interviewed to obtain the same assessments, blood sample and magnetic resonance imaging scan in multi-modalities as before.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with intracranial stenosis which was defined as stenosis of 50% or more in Intracranial segment of internal carotid artery(C6-C7) and middle cerebral artery (M1).
2. The degree of stenosis was measured by transcranial doppler, computed magnetic resonance angiography (MRA),tomography angiography (CTA) and digital subtraction angiography (DSA).

Exclusion Criteria:

1. History of stroke,transient ischemic attack,seizures or unexplained loss of consciousness.
2. Organic brain defects on MRI T1 or T2 images.
3. Any history or clinical signs of other severe psychiatric illnesses (like major depression,psychosis or obsessive compulsive disorder).
4. Implanted pacemaker,medication pump,vagal stimulator,deep brain stimulator. History of substance abuse within the last 6 months.
Comparison of the Effects of Two Glaucoma Drugs Over 24 Hours (0507A-137)(COMPLETED)

This study is comparing 2 medications for glaucoma and how effective they are at controlling glaucoma over the course of an entire day.


Eligibility Criteria:
Inclusion Criteria:

* Patients with glaucoma or ocular hypertension

Exclusion Criteria:

* Other eye conditions
* Poor vision
* Recent eye surgery
* Use of contact lenses
* Nursing or pregnant women
* Use of some other selected medications
* Drug or alcohol abuse
* Asthma
* Slow heart beat
* Allergy or previous reaction to study drugs
Desmopressin for Bedwetting in Children With SCD

This study assesses if using the medication desmopressin will decrease nightime bedwetting in children with sickle cell disease.

Night time bedwetting is a common complication of sickle cell disease, and affects up to 30 % of children. Desmopressin is an oral medication that increases water reabsorption in the kidneys. Studies have shown that it is effective in decreasing bedwetting episodes in children without sickle cell disease. Chronic sickling episodes causing damage to the kidneys could cause permanent damage and may make this treatment ineffective in sickle cell disease. This trial will inform pediatric sickle cell doctors if desmopressin is an appropriate treatment for bed wetting in the investigators patients.

This study expanded upon a previously terminated study which had separately registered (NCT02636387, ID: 2014-3768).

Eligibility Criteria:
Inclusion Criteria:

1. Patients with Hemoglobin SS, SC, SB0thal or SB+thal
2. Patients with at least two episodes of primary nocturnal enuresis per week or four episodes over the two weeks prior to enrollment.
3. Patients with secondary enuresis who have been evaluated and cleared by a pediatric urologist as not having other etiologies of enuresis (e.g. overactive detrusor activity, a genitourinary anatomic abnormality)

Exclusion Criteria:

1. Patients with developmental delay or neurologic dysfunction secondary to stroke.
2. Patients with hypertension or underlying renal disease.
3. Patients with genitourinary anatomic abnormalities. Any prior renal ultrasound showing normal genitourinary anatomy is sufficient to clear a patient for the study.
4. Patients with daytime urinary incontinence
5. Patients with glucosuria on urinalysis.
6. Patients with secondary nocturnal enuresis who have not been evaluated by a pediatric urologist to rule out other etiologies of enuresis.
7. Patients who are pregnant.
8. Patients receiving another medicine for nocturnal enuresis (e.g. imipramine).
Study to Evaluate the Safety and Efficacy of Denosumab and Actonel® in Post Menopausal Women Transitioned From Alendronate Therapy

A randomized, open label study to assess the safety and effectiveness of Denosumab, administered every 6 months and Actonel ® (Risedronate), administered monthly in post menopausal women transitioned from weekly or daily Alendronate therapy.


Eligibility Criteria:
Inclusion Criteria:

* Ambulatory, post menopausal women aged 55 years or older at screening. Have received their first prescription of daily or weekly alendronate therapy, for the treatment for post menopausal osteoporosis at least 1 month prior to screening. Use of raloxifene, calcitonin or hormone replacement therapy (HRT) prior to alendronate treatment will be allowed. Prior and/or current use of vitamin D and calcium will be allowed.
* Has stopped oral alendronate therapy (is denoted as non-persistent) before the screening visit or, is still taking oral alendronate therapy but does not take on a regular basis (this will be assessed by the completion of a compliance questionnaire at screening).
* Provide signed informed consent before any study-specific procedures are conducted.

Exclusion Criteria:

* Any prior or current use of medications prescribed for osteoporosis treatment other than oral daily alendronate, calcium and vitamin D. Prior use of raloxifen, calcitonin or HRT before alendronate therapy was started will be allowed.
* Hypersensitivity to Actonel® or any ingredient of Actonel® tablets.
* Contraindicated or poorly tolerant of alendronate therapy.
* Active gastric or duodenal ulcer.
* Known sensitivity to mammalian cell derived products.
* Known intolerance to calcium supplements.
* Malignancy within the last 5 years (except for cervical or basal cell carcinoma).
* Vitamin D deficiency (serum 25-OH vitamin D less than 20ng/mL (equivalent to 49.9 nanomoles per Liter) at screening.
* Current hypo- or hypercalcemia based on the central laboratory reference ranges.
* Uncontrolled hyper- or hypothyroidism (stable on antithyroid therapy or post-ablation is allowed, if the laboratory results from screening show that thyroid stimulating hormone (TSH) is within the normal range).
* Any metabolic bone disease, e.g., osteomalacia or osteogenesis imperfecta, Paget's disease of bone that may interfere with the interpretation of the findings.
* Height, weight or girth which may preclude accurate dual x-ray absorptiometry (DXA measurements).
* Fewer than 2 lumbar vertebrae (L1-L4) able to be evaluated by DXA.
* Known to have tested positive for human immunodeficiency virus.
* Previous participation in clinical trials with denosumab within the last 12 months (regardless of treatment).
* Any laboratory abnormality, physical or psychiatric disorder (including substance abuse in last 12 months) which, in the opinion of the investigator, will prevent the subject from giving written informed consent or completing the study or interfere with the interpretation of the study results.
* Currently enrolled in or within 30 days of ending another investigational device or drug trial(s).
Liberal Versus Restrictive Transfusion Guidelines for Preterm Infants

The purpose of this study was to determine whether restrictive guidelines for red blood cell (RBC) transfusions for preterm infants can reduce the number of transfusions without adverse consequences.

Design, Setting, and Patients. We enrolled 100 hospitalized preterm infants with birth weights 500 to 1300 g into a randomized clinical trial comparing two levels of hematocrit threshold for RBC transfusion.

Intervention. The infants were randomly assigned to either the liberal or the restrictive transfusion group. For each group, transfusions were given only when the hematocrit fell below the assigned value. In each group, the transfusion thresholds decreased with improving clinical status.

Main Outcome Measures. We recorded the number of transfusions, the number of donor exposures, and various clinical and physiological outcomes.

Results. Infants in the liberally transfused group received more RBC transfusions, mean 5.2 (SD 4.5) vs 3.3 (SD 2.9) in the restrictive transfusion group (P=0.025). However, the number of donors to whom the infants were exposed was not significantly different, mean 2.8 (SD 2.5) vs 2.2 (SD 2.0). There was no difference between the groups in the percentage of infants who avoided transfusions altogether, 12% in the liberal transfusion group vs 10% in the restrictive group. Infants in the restrictive group were more likely to have intraparenchymal brain hemorrhage or periventricular leukomalacia (P=0.012), and they had more frequent episodes of apnea (P=0.004), including both mild and severe episodes.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infant
* Birth weight 500-1300 grams

Exclusion Criteria:

* Alloimmune hemolytic disease
* Congenital heart disease
* Other major birth defect requiring surgery
* Chromosomal abnormality
* Thought to be facing imminent death
* Parental philosophical or religious objections to transfusion
* More than 2 transfusions before enrollment
* Participation in other research study with potential impact on this study