cyrilzakka/clinical-trials huggingface dataset:
Severe Sepsis in Children - IMPRESS-C

Sepsis is the most common cause of childhood death worldwide. Millions of children survive, but are left with impaired health. Sepsis-related Acute Kidney Injury (sAKI) is increasingly recognized as a significant factor associated with long-term mortality among different patient populations. Renal dysfunction and subsequent chronic kidney disease is implicated in the development of hypertension and cardiovascular disease. The investigators overall hypothesis is that, in the pediatric population, sepsis-related AKI will have unrecognized, long-term consequences with regard to kidney function, endothelial function, blood pressure control, and overall health.

This will be a two-arm cross-sectional control-cohort outpatient evaluation. Subjects with sAKI and control subjects (age and gender matched) will be recruited from neurology service. Subjects will be asked to come in to the Clinical Research Center for 24-hour monitoring and participate in the outpatient study where urinary and serum studies to measure glomerular filtration rate, renal plasma flow followed by blood pressure monitoring, peripheral arterial and applanation tonometry.

Eligibility Criteria:
Inclusion Criteria:

For all patients:

* Ability to assent (age 7-17 at time of participation in the study)
* If taking antihypertensive medication, prescribing practitioner's written approval to participate

For sAKI patients:

* Hospitalization with a diagnosis of sepsis from 1998-2014
* Severe AKI as defined by the pEDRIFLE criteria during incident sepsis admission
* Participation in cognitive survey study with completion of the PedsQL survey

For healthy control patients:

• Patients from the neurology service undergoing MRI with gadolinium as a part of their clinical care

Exclusion Criteria:

For all patients:

* Known pre-existing CKD as defined by history of kidney transplant or long-term dialysis
* Age greater than 17 years at the time of incident sepsis admission
* AKI from primary kidney disease including acute glomerulonephritis and obstructive uropathy
* Pregnancy at the time of enrollment
* Known or suspected allergy to gadolinium based contrast
* Known or suspected allergy to iodohippurate will be excluded from RPF measurement with iodohippurate
* Heart failure or condition whereby the administration of 0.9% normal saline would be contraindicated
* If taking antihypertensive medication, lack of prescribing practitioner's written approval to participate

For healthy control patients:

* Chronic kidney disease
* History of acute kidney injury or GFR \<100 History of chronic illnesses deemed to predispose to renal or cardiovascular dysfunction or abnormalities Suspicion of infection
* Neuro-vascular history such as encephalitis, meningitis, vascular anomalies of the brain or spinal cord or cerebrovascular infarct or ischemia will be excluded .
* No indication for gadolinium administration for MRI
The Impact of Community Exercise on Social Connectedness and Falls in Older Adults: Leveraging Exercise to Age in Place

The goal of this study is to reduce risk of falls and social isolation in older adults age 50+ through participation in community based health and exercise programs.

PRIMARY HYPOTHESES: In community-dwelling ambulatory older adults (age ≥50 years) participation in a community-based group program will improve the Duke Social Support Index (DSSI) score by four points measured after six to eight participation in the program when compared to the DSSI score prior to participation in the program. This increase will be sustained at 26 week follow-up.

SECONDARY HYPOTHESES: Participants in the community-based group exercise activities will have decreased fall risk when measured after six to eight weeks participation in the program when compared to pre-participation as based on responses to the fall risk questionnaire. Cedars-Sinai patients who participate in the community-based programs will have a decrease in health care utilization (as measured by physician visits, Emergency Department visits, and hospitalizations) in the 26 weeks after program enrollment compared to the 26 weeks prior to program enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Must be cognitively stable and must be 50 years or older

Exclusion Criteria:

* \<50 years
* Cognitive impairment
Neuronal and Behavioral Effects of an Implicit Priming Approach to Improve Eating Behaviors in Obesity

The purpose of this study is to determine how different behavioral interventions designed to alter food perceptions and behaviors affect brain responses to food, eating behaviors, and body weight.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old
* BMI of 27 or greater

Exclusion Criteria:

* MRI contraindications (e.g., metal or electronic devices in the body)
* Pregnancy
Active Video Games on Physical Activity (Main Trial)

The purpose of the study is to test the effects of different versions of active video games (AVGs) on body composition, cardiometabolic risks, and cognitive functions among overweight/obese children over 6 months.

The study aims to explore the effects of narrative-enhanced AVG on (1) body composition, (2) cardiometabolic risks, and (3) cognitive functioning among overweight/obese 8-12 years old children over 6 months.

A total of 210 children will be recruited from Tufts Floating Hospital, Boston Children's Hospital, and Martha Eliot Health Center. The investigators divided the participants into three groups to evaluate the effect of using active game consoles and stories to motivate children to exercise: A third of them have standard clinical care only; a third of them have the same standard clinical care plus an Xbox and active games; the remaining third of them have the same standard clinical care, an Xbox and active games, plus the stories delivered to their Xbox consoles.

Each child, accompanied by their guardian, will be asked to visit the Northeastern University Exercise Science Laboratory over the 6-month period. Blood samples, body composition (using Dual-energy X-ray absorptiometry, or DEXA Scan), and cognitive and affective evaluations of the active video games (AVGs) will be collected. Additionally, parents will be asked to fill out questionnaires related to their child's physical activity behaviors. Children would also be required to wear two accelerometers (essentially, a "smart watch" or activity tracker) on their wrist and waist for 7 consecutive days after the three visits within the 6 months.

Eligibility Criteria:
Inclusion Criteria:

* 8-to-12-year-old
* Being overweight or obese (BMI% \>=85)
* Speak and understand English
* Are willing and able to complete all measures
* Equal numbers of both genders will be recruited
* One child per household will be eligible to participate

Exclusion Criteria:

* Not between 8 and 12
* Not being overweight or obese
* Do not speak and understand English
* Have medical or physical problems that prevent them from playing AVGs, such as epilepsy
* Use orthopedic devices
Risk for Subsequent Osteoradionecrosis in A Transferred Fibula Flap in Head and Neck Cancer Patients Undergoing Segmental Mandibulectomy: a Cohort Study

A retrospective analysis of 329 patients at one single institution between January 2014 and December 2019 who underwent free fibula flap reconstruction was conducted. A variety of clinicopathological postoperative parameters were identified and assessed.

The study was conducted as a monocentric, retrospective study. Patients who underwent a mandibular reconstruction with a free fibula flap due to head and neck cancer through January 2014 to December 2019 at one single institution in Taiwan were identified. All charts including surgical records, progress notes, nursing records, clinic notes, imaging study after surgery were reviewed. Data extraction was performed for the following variables: Patient demographics, primary diagnosis, cancer location and staging, treatment prior to index surgery, postoperative hemoglobin and albumin, operating time, flap type, mandibular defect length, type of the defect according to Jewer's classification, ischemia time, number of fibula segments, plate type, re-exploration, time of hospitalization, postoperative radiotherapy and/or chemotherapy, ORN cases, identification time of ORN and management for ORN. The patients were then organized into two groups: ORN and non-ORN. This research was approved by the Institutional Review Board of our hospital (No. 201800172B0), which was available until 2022/02/28. The investigators completed data analysis before 2022/02/28 and then initiated manuscript preparing.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent a mandibular reconstruction with a free fibula flap due to head and neck cancer through January 2014 to December 2019.

Exclusion Criteria:

* Cases with incomplete medical records.
* Patients who did not attend at least 6 months of follow ups.
A BRIDGING STUDY OF PF-06439535 (CN) PLUS PACLITAXEL-CARBOPLATIN VERSUS BEVACIZUMAB PLUS PACLITAXEL-CARBOPLATIN IN NSCLC

The current study will compare the efficacy, safety, pharmacokinetics and immunogenicity of PF-06439535 (CN) in combination with paclitaxel and carboplatin versus bevacizumab sourced from the European Union (bevacizumab-EU) with paclitaxel and carboplatin in Chinese participants with advanced non-squamous NSCLC in the first-line treatment setting.


Eligibility Criteria:
Inclusion Criteria:

* Male and female participants age at least 18 years of age.
* Newly diagnosed Stage IIIB, IIIC or IV non small cell lung cancer (NSCLC) (according to American Joint Committee on Cancer (AJCC) Staging Manual, 8th Edition, last updated 05 June 2018) or recurrent NSCLC.
* Histologically or cytologically confirmed diagnosis of non-squamous NSCLC.
* At least one measurable lesion as defined by RECIST v1.1.
* Be eligible to receive bevacizumab, paclitaxel, and carboplatin based on local standard of care, for the treatment of advanced or metastatic non-squamous NSCLC.

Exclusion Criteria:

* Small cell lung cancer (SCLC) or combination SCLC and NSCLC. Squamous-cell tumors and mixed adenosquamous carcinomas.
* Evidence of a tumor that compresses or invades major blood vessels or tumor cavitation that, in the opinion of the investigator, is likely to bleed.
* Known EGFR activating mutations (for example, exon 19 deletion or exon 21 L858R substitution mutations) or ALK rearrangements.
* Prior systemic therapy for advanced NSCLC; prior neoadjuvant or adjuvant therapy is allowed if surgical resection for primary disease was performed.
Effectiveness and Safety of Limbal Relaxing Incisions for Correcting Post Phacoemulsification High Astigmatism

To compare the effect of Limbal relaxing incisions (LRIs) plus spectacle correction versus spectacle correction alone on subjective and objective improvement in visual function for correcting post phacoemulsification high astigmatism .

Astigmatism is one of the commonest refractive errors encountered during our clinical practice. Surgically induced astigmatism is the main obstacle to achieve good uncorrected visual acuity following cataract surgery. It is estimated that corneal astigmatism of more than 1.0 diopter (D) is found in up to 40% of patients presenting for cataract surgery, 1.5D or more is present in over 20% and above 2.0D in 10%.

Astigmatism induces distortion of the image leading to compromise quality of vision. In order to achieve better visual results, the effect of postoperative astigmatism should be minimized, management options for corneal astigmatism include glasses, contact lenses, and surgery such as Limbal relaxing incisions (LRIs), refractive laser surgery, toric lenses or rarely corneal grafting. The LRIs technique involves the placement of incisions corresponding to the steep meridian, resulting in corneal flattening and the reduction of astigmatic power. LRI is a safe and an inexpensive procedure, which is simple for experts to perform. Although most of the nomograms recommended that LRIs technique can correct up to 3 D of astigmatism ,it has been found that it is possible to correct even more than 4 D if the incisions were performed on high degrees of astigmatism.

Eligibility Criteria:
Inclusion Criteria:

* Conventional phacoemulsification was done at least one month earlier.
* Clear cornea with corneal astigmatism more than 3.0 D.

Exclusion Criteria:

* History of corneal surgeries (e.g., keratoplasty, refractive surgery, and corneal wound repair).
* Ocular trauma.
* Other intraocular surgery.
* Patient with corneal opacities.
* Thin cornea .
* Any significant ocular disease causing diminution of vision (e.g., optic atrophy, diabetic retinopathy, and age-related macular degeneration), autoimmune disease, and peripheral corneal disease.
Evaluation of the Utility of an EEC for Assessing Efficacy of SIT in Pivotal Clinical Trials

The study will explore how allergy symptoms experienced during the grass pollen season compare to symptoms experienced in the Environmental Exposure Chamber (EEC).

There are 2 treatments in this study. Both treatments are injected under the skin. Allergovit® Grasses works by helping the body's immune system get used to grass-pollen before the grass pollen season begins which may lead to decreased sensitivity and reduced allergy symptoms during the grass season. Placebo treatment does not contain grass pollen mixture, and is not expected to reduce allergic symptoms overtime.

This is a Phase II trial, with a one year observational/baseline phase followed by a one year double-blind placebo-controlled, randomized, treatment phase. Approx. 137 grass pollen-allergic subjects and 20 non-allergic subjects will be enrolled in the baseline phase of the study. The primary objective of the trial is to investigate the relationship between allergy symptoms experienced by subjects (allergic and non-allergic) upon exposure to grass pollen-allergen in the EEC and the allergy symptoms experienced by subjects during the grass pollen season.

Eligibility Criteria:
Inclusion Criteria:

* IgE-mediated seasonal allergic rhinitis/rhinoconjunctivitis with or without allergic asthma
* positive skin prick test
* specific IgE ≥ 0.70 kU/L to mixture of grass pollen allergens
* symptom score of at least 4 per day during the week following the peak-pollen count in the baseline season

Exclusion Criteria:

* undergone previous specific immunotherapy with grass pollen allergens in any formulation less than 5 years prior to the screening date
* currently undergoing any sort of immunotherapy, or has ever undergone specific immunotherapy with unknown allergen
* allergens which are expected to interfere with the grass pollen season
* uncontrolled or partly controlled asthma
* patients with contraindications for SIT
Transplantation of Cultivated Limbal Epithelium on Amniotic Membrane for Limbal Stem Cell Deficiency

To evaluate the effectiveness of autologous (tissue from fellow eye) transplantation of cultivated limbal epithelium on amniotic membrane to treat severe surface irregularity and scarring of the corneal surface.

The corneal epithelium is under constant cell-turnover,and it has been shown that the limbus is the ultimate source of epithelial renewal. Significant damage to limbal cells causes a disease state called limbal stem cell deficiency(LSCD),characterized by different extents of conjunctival overgrowth onto cornea, vascularization, chronic inflammation, and poor epithelial integrity.

In unilateral LSCD, the damaged corneal surface may be reconstructed using two large segments of healthy limbal tissue (of approximately 6-8mm by 1mm) from the fellow eye in the procedure of conventional limbal transplantation.This may however compromise ocular surface integrity of the healthy eye depending on the amount of donated limbus. In more recent years, it has been possible to "save" limbal tissue by obtaining only a very small limbal biopsy (2mm by 1mm) from the fellow healthy eye which is "expanded" into a viable sheet of limbal cells via laboratory cultivation.This cultivated sheet of cells is transplanted to treat the damaged ocular surface.

This study is a prospective nonrandomized trial which evaluates the efficacy of transplantation of autologous ex-vivo expanded limbal epithelium on intact amniotic membrane for unilateral total limbal stem cell deficiency.

Eligibility Criteria:
Inclusion Criteria:

* unilateral total limbal stem cell deficiency with normal fellow eye, or minimally damaged fellow eye (less than 1/3 limbus affected)

Exclusion Criteria:

* systemic disease affecting both eyes such as Stevens-Johnson syndrome
PK Study of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution in Patients Undergoing Vitrectomy

The purpose of this study is to evaluate the pharmacokinetics (PK) of dexamethasone phosphate ophthalmic solution delivered via the EyeGate® II Drug Delivery System (EGDS) in patients undergoing vitrectomy for macular hole repair or epiretinal membrane peeling

This is an open-label, multi-center, single-dose, Phase 1 clinical trial designed to evaluate the pharmacokinetics (PK) of dexamethasone phosphate ophthalmic solution delivered via the EyeGate® II Drug Delivery System (EGDS) in the vitreous humor taken from patients undergoing vitrectomy for macular hole repair or epiretinal membrane peeling

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 to 85 years
2. Receive, understand, and sign a copy of the written informed consent form

Exclusion Criteria:

-
Japanese BAY88-8223 Monotherapy Phase II Study

To evaluate the efficacy and safety of the best standard of care plus BAY88-8223 in Japanese patients with CRPC and bone metastases after a multiple administration


Eligibility Criteria:
Inclusion Criteria:

* Have received docetaxel or not eligible for the first course of docetaxel, i.e. patients who are not fit enough and willing.
* Histologically or cytologically confirmed adenocarcinoma of the prostate
* Multiple bone metastases
* Either regular (not occasional) analgesic medication use for cancer-related bone pain or treatment with external beam radiotherapy (EBRT) for bone pain.
* Best standard of care(BSoC) is regarded as the routine standard of care.

Exclusion Criteria :

* Treatment with cytotoxic chemotherapy within previous 4 weeks, or planned during the treatment period
* History of visceral metastasis, or presence of visceral metastasis
The Prevalence of Radial Artery Occlusion in Diagnostic Cardiac Catheterization and Percutaneous Intervention

The purpose of this study is to establish the rate of radial artery occlusion post transradial cardiac catheterization through different modalities.

The study hypothesis is that specialized imaging can provide specific information to help identify hand complications after cardiac catheterization through the wrist.

The purpose of this study is to establish the rate of radial artery occlusion post diagnostic/interventional cardiac catheterization through different modalities, and to compare current assessment methods (such as Allen's test, Modified Barbeau test and duplex ultrasonography) to specialized imaging techniques for sensitivity and specificity of radial artery occlusion detection post transradial catheterization.

The study hypothesis is that specialized imaging can provide a specific focused analysis of hand characteristics to identify physiologic abnormalities as a result of radial artery occlusion post transradial catheterization.

Eligibility Criteria:
Inclusion Criteria:

* Adult subjects over the age of 18 who present to the Jesse Brown VA cath lab for a diagnostic radial artery angiogram or percutaneous intervention will be considered for the study.

Exclusion Criteria:

* Any subject who is unable to give informed consent or declines to participate will be excluded.
* Patients who have previously had a cardiac catheterization through the radial artery will be excluded because it will not be known if the changes to the circulation of the hand is secondary to the current or previous transradial catheterization.
Determination of the Utility of Pfizer's Pneumococcal Urine Antigen Test in Children 5 Years of Age or Younger With Community Acquired Pneumonia in Guatemala

This prospective case-control study aims to evaluate the utility and establish laboratory thresholds for a multi-serotype urine antigen test for the diagnosis of pneumococcal community acquired pneumonia in children 5 years of age or younger in Guatemala.


Eligibility Criteria:
CASES:

Inclusion Criteria:

* Age older than 1 month (31 days) and up to 71 months and 28 days.
* Diagnosis of radiologically confirmed pneumonia per WHO criteria in the ED or hospital within 48 hours of hospital admission
* Signed informed consent by parents or legal guardian to participate in the study

Exclusion Criteria:

* Known immunodeficiency
* Major congenital malformation (e.g., hemodynamically compromised congenital heart malformation or any malformation leading to recurrent pneumonia) or serious chronic disorder
* Significant neurological disorder
* Hospitalization within the previous 30 days for pneumonia or respiratory infection
* Use of parenteral antibiotics for current illness (leading to diagnosis of pneumonia)
* Transferred to the study hospital after already being hospitalized at a different location for ≥ 48 hours

CONTROLS:

Inclusion Criteria:

* Age 1 to 71 months and signed informed consent by parents or legal guardian

Exclusion Criteria:

* Known immunodeficiency
* Major congenital malformation (e.g., hemodynamically compromised congenital heart malformation or any malformation leading to recurrent pneumonia) or serious chronic disorder
* Significant neurological disorder
* Fever or suspicion of community-acquired pneumonia or other respiratory infectious disease (symptoms of cough, congestion, tachypnea, indrawing, etc.)
* Hospitalization within the previous 30 days for pneumonia or respiratory infection
Comparison of 4 Tactical Tourniquets Used in War Medicine

Bleeding remains the leading cause of death in combat, and the literature suggests that tourniquetable hemorrhage is the second leading cause of preventable death, behind non- tourniquetable hemorrhage.

Currently, most Western armed forces recommend the use of the tactical tourniquet in combat for the management of tourniquetable hemorrhage.

The SOFTT® tourniquet (Tactical Medical Solutions, Anderson) is the tactical tourniquet currently in use by the French armed forces. As the contract will soon come to an end, the question of its renewal arises.

The purpose of this study is to compare 4 commercially available tactical tourniquets in healthy volunteers.

The hypothesis of the research is that one of the 4 tourniquets compared is faster to set up than the others.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years;
* Student of the Military Health School of Lyon Bron (Ecoles Militaires de Santé de Lyon Bron; EMSLB);
* Periodic medical examination up to date with the mention "fitness for duty";
* Holder of the "Combat Rescue Level 1" training.

Exclusion Criteria:

* Vascular pathology;
* Current progressive pathology of any kind;
* History of thrombo-embolic disease;
* Presence of cardiovascular risk factors (diabetes, hypertension, dyslipidemia, smoking \> 1 cigarette/day, BMI \> 25);
* Iliofemoral and axillary vascular abnormalities detected by systematic Doppler ultrasound;
* Presence of symptoms suggestive of COVID-19;
* Positive COVID-19 antigen test;
* In contact with a person diagnosed positive for COVID-19 within 15 days prior to inclusion;
* Pregnant or breastfeeding woman.