cyrilzakka/clinical-trials huggingface dataset:
A Trial of Mechanical Axis vs Kinematic Alignment in Total Knee Replacement

This is a prospective, randomized, longitudinal study of the clinical outcomes of osteoarthritis patients treated by two different alignment philosophies for total knee replacement. In this study ShapeMatch® cutting guides will be compared to the conventional approach.


Eligibility Criteria:
Inclusion Criteria:

* The patient is a male or non-pregnant female between the ages of 40-80 years.
* The patient requires a primary total knee replacement and is indicated for computer-assisted surgery.
* Patient is deemed appropriate for a cruciate retaining knee replacement.
* The patient has a primary diagnosis of osteoarthritis (OA).
* The patient has intact collateral ligaments.
* The patient is able to undergo MRI scanning of the affected limb.
* The patient has signed the study specific, ethics-approved, Informed Consent document.
* The patient is willing and able to comply with the specified pre-operative and post-operative clinical and radiographic evaluations.

Exclusion Criteria:

* The patient has a history of total, unicompartmental reconstruction or fusion of the affected joint.
* Patient has had a previous osteotomy around the knee.
* The patient is morbidly obese (BMI ≥ 40).
* The patient has a deformity which will require the use of stems, wedges or augments in conjunction with the Triathlon Total Knee System.
* The patient has a varus/valgus malalignment ≥ 15° (relative to mechanical axis).
* The patient has a fixed flexion deformity ≥ 15°.
* The patient has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
* The patient has a systemic or metabolic disorder leading to progressive bone deterioration.
* The patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements.
* Patient has a cognitive impairment, an intellectual disability or a mental illness.
* The patient is pregnant.
* The patient has metal hardware present in the region of the hip, knee or ankle (as this is known to create geometrical distortion in the region of the implant).
* The patient has any known contraindications for undergoing assessment by MRI (e.g. ferrous implants, metallic clips, magnetically activated implanted devices such as cardiac pacemakers, etc).
A Comparison Between Child-Pugh and Albumin-Bilirubin Scores

To compare Child-Pugh and Albumin-Bilirubin scores in patients with spontaneous rupture of hepatocellular carcinoma

To compare Child-Pugh and Albumin-Bilirubin scores in patients with spontaneous rupture of hepatocellular carcinoma. And to determine which is better in predicting long-term survival and short-term survival.

Eligibility Criteria:
Inclusion Criteria:

* Be diagnosed as hepatocellular carcinoma pathologically; had a tumor rupture confirmed by Intraperitoneal exploration or clinical signs and symptoms in combination with imaging examination.

Exclusion Criteria:

* Be diagnosed as not hepatocellular carcinoma pathologically；had repeated transcatheter arterial chemoembolization(TACE) or a long history (more than 1 year) of cancer treatment; loss of follow up or without complete data.
The Effectiveness of Silver Alginate (Algidex) Patch in the Prevention of Central Line Infections in Very Low Birth Weight Infants

The purpose of this study is to determine whether silver alginate (Algidex) patch is effective in the prevention of central line infections in very low birth weight infants.

With rapid technological advancement, the increased use of vascular catheters has not only improved patient care strategies, but also contributed to the risk of infection. Unfortunately, catheter related blood stream infections still remain one of the major causes of morbidity in VLBW infants. In the United States, approximately 850,000 infections are attributed to catheters annually, occurring primarily in intensive care unit patients. The National Institute of Child Health and Human Development stated that 20% of infants less than 1500 grams will have at least one positive blood culture delaying their stay in the neonatal intensive care unit (NICU).

One approach to reducing the incidence of infection could be utilizing the antimicrobial properties of silver. Silver alginate has been proven safe and beneficial in the adult population in preventing catheter related infections. Studies done in mice and rats suggest acute toxicity occurring when the animals were given 23 mg of silver acetate/kg of body weight and chronic toxicity noticed when animals were given 1.5 mg/kg/day (5) Chronic toxicity in humans was shown with ingestion of 13 mg/kg/day (3) In our recently concluded pilot randomized controlled trial done in VLBW infants, safety of silver alginate was demonstrated by lack of skin reactions to the patches and mild increase in serum silver level ( Khattak et al; Pediatrics research March 2008, clinicaltrials.gov id: NCT00593684 ). However, there is no clinical evidence of efficacy in VLBW neonatal population. Based on the data from our pilot safety study, we hypothesize that using silver alginate dressing in this population will be efficacious in the prevention of blood stream infections. Although initial studies suggest that absorbed silver is not in a range toxic to human infants, we will continue to monitor silver levels in certain infants.

Eligibility Criteria:
Inclusion Criteria:

1. Infants with birth weights between 500 and 1500 grams admitted to the NICU with any of the following lines will be eligible for inclusion in this study

   1. umbilical arterial line (UAL)
   2. umbilical venous line (UVL)
   3. peripheral arterial line (PAL)
   4. peripheral long line (PLL)
   5. central venous line (CVL)
2. Each eligible subject will be randomized to receive either standard of care or silver alginate dressing. Dressings will be changed every 7 days in accordance to current facility protocols.

Exclusion Criteria:

1. Any infant born with a lethal abnormality or who has received topical Silver therapy will be excluded from the study.
Immediate Effect of Electrical Noise Stimulation on Neuromuscular Adaptation of Balance

Noise stimulation had an immediate effect on improving balance control. The present study aimed to clarify the immediate neuromuscular adaptation induced by noise stimulation and find the correlation between neuromuscular adaptation and functional performance.

The mechanism behind noise stimulation is called Stochastic Resonance which improves the detectivity of sensory input with the presence of noise, making sub-sensory threshold input detectable. Noise stimulation had been proved to improve postural control, Ia afferent sensitivity, and muscle activity of the tibialis anterior. With this evidence of the effect of noise stimulation on balance enhancement, the neuromuscular adaptation induced by noise stimulation has not been researched yet. Therefore, the present study aims to clarify the immediate effect of noise on neuromuscular regulation during postural control.

Eligibility Criteria:
Inclusion Criteria:

* age between 20 and 40 years old
* without ankle injury history in 1 year
* without musculoskeletal or neurological diseases that would affect balance performance
* without visual impairment (except vision correction or no visual problems)
* without vestibular impairment.

Exclusion Criteria:

* subject who cannot tolerate the cutaneous electrical stimulation to induce H reflex
* single-leg stance (SLS) without support is shorter than 80 secs
Study 1 Replication and Extension of Prior Work

The goal of this research is to explore abilities to learn word meanings from overheard conversations in children with ASD (and, as a control, typically developing children).

Specific Aim 1 (Experiment 1): Subaim 1a: Identify child characteristics associated with learning from overhearing. In a prior study, the investigators found that 13 children with ASD were able to learn the meanings of novel words that they heard used in a conversation involving two adults. In the current study, the investigators aim to study a larger sample to identify what child characteristics are associated with good learning in an overhearing situation as compared to a situation in which the child is directly taught the new word. Subaim 1b: Assess retention and generalization of words learned from overhearing. The investigators will re-test children on their knowledge of the word meanings after a 10-minute delay to see if they both retain the word meanings and can generalize the new words to new situations.


Eligibility Criteria:
Inclusion Criteria:

* children with or without a diagnosis of ASD between 18 to 71 months of age

Exclusion Criteria:

* native language is not English
* born premature (\< 36 weeks)
* has uncorrected hearing or vision impairments
* has developmental disorders or medical conditions other than ASD that affect language or cognition (excepting psychiatric conditions often comorbid with ASD such as ADHD)
* has a history of photosensitive epileptic seizures
Randomized Comparison of Catheter-based Strategies for Interventional Access Site Closure During Transfemoral Transcatheter Aortic Valve Implantation

The aim of the study is to evaluate the clinical efficacy of 2 different vascular closure device (VCD) strategies during transfemoral transcatheter aortic valve implantation (TAVI). The study hypothesizes that the choice of one over the other VCD in patients undergoing transfemoral TAVI may demonstrate relevant differences in the rate of peri-procedural complications and effectiveness of vascular closure.

Use of a plug-based VCD in patients undergoing transfemoral TAVI as compared to a suture-based VCD.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with an indication for transfemoral TAVI as judged by the local heart team.
2. Transfemoral access route and a commercially-available transcatheter aortic valve is selected by the local heart team.
3. The patient is willing to provide written informed consent and comply with protocol- specified follow-up evaluations.

Exclusion Criteria:

1. Vascular access site anatomy not suitable for percutaneous vascular closure.
2. Vascular access site complications prior to the TAVI procedure.
3. Known allergy or hypersensitivity to any VCD component.
4. Unstable active bleeding/ bleeding diathesis or significant unmanageable anemia.
5. Absence of computed tomographic data of the access site before the procedure.
6. Systemic infection or a local infection at or near the access site.
7. Life expectancy of less than 6 months due to non-cardiac conditions.
8. Patient cannot adhere to or complete the investigational protocol for any reason.
9. Pregnant or nursing subjects.
10. Participation in any other interventional trial.
HRS9531 Injection in Obese Subjects With Heart Failure With Preserved Ejection Fraction

This was a multicenter, randomized, double-blind, placebo-parallel-controlled Phase II clinical study to evaluate the efficacy and safety of HRS9531 Injection compared to placebo in obese subjects with heart failure with preserved ejection fraction.

A total of 200 obese subjects with heart failure with preserved ejection fraction would be enrolled. Eligible subjects were randomly assigned to either HRS9531 group or placebo group and were treated with HRS9531 injection or placebo, respectively, for 52 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, age above or equal to 18 years at the time of signing informed consent.
2. Body mass index (BMI) greater than or equal to 28.0 kg/m\^2
3. New York Heart Association (NYHA) Class II-IV;
4. Left ventricular ejection fraction (LVEF) greater than or equal to 45 percentage at screening

Exclusion Criteria:

1. Medical history of myocardial infarction, acute decompensated heart failure, heart failure requiring hospitalization or urgent heart failure visit, unstable angina, stroke, or transient ischemic attack within 30 days prior to or at screening;
2. Haemoglobin A1c (HbA1c) greater than or equal to 11.0% at screening.
Contrast Induced Acute Kidney in Patients With Acute Stroke

Computed tomographic angiography (CTA) is recommended for identifying eligible patient with acute ischemic stroke (AIS) to receieve endovascular treatment. We are going to conduct this prospective corhot study to observe if sequential use contrast in CTA examination and in endovascular treatment will cause acute kidney injury.


Eligibility Criteria:
Inclusion Criteria:

* All patients who are suspected with AIS.
* Non-contrast head CT excludes intracranial hemorrhage.

Exclusion Criteria:

* Lacking of pre-CTA Creatinine
* Lacking of post-angiography Creatinine with 24-48 hours
Johns Hopkins Weight Management Center Patient Data

Patient records from Johns Hopkins Weight Management Center historical files

Examination of historical patient files from the Johns Hopkins Weight Management Center, to be conducted by a study team led by the attending physician and director of the Center. Analyses will examine weight-related outcomes based on participation in the Weight Management Center program.

Eligibility Criteria:
Inclusion Criteria:

* enrolled as a patient at the Johns Hopkins Weight Management Center

Exclusion Criteria:

* none
Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis Patients Infected With Burkholderia Cepacia Complex

The objective of this study is to determine if tobramycin inhalation powder (TIP) can reduce the amount of Burkholderia Cepacia Complex (BCC) species - type of bacteria, in the sputum of cystic fibrosis patient.


Eligibility Criteria:
Inclusion Criteria:

* Age 6 years or older
* Diagnosis of CF based on the following: sweat chloride\>60 mEq/L or genotype with 2 identifiable mutations consistent with CF; and one or more clinical features consistent with CF.
* Chronically infected with a Burkholderia cepacia complex species (\>50% of respiratory specimens positive in the 24 months prior to screening).
* Able to produce sputum (expectorated or induced).
* Able to reproducibly perform pulmonary function testing.
* Written informed consent provided.

Exclusion Criteria:

* Post lung transplantation.
* Pregnancy.
* Acute exacerbation requiring IV or oral antibiotics within 14 days
* Patients currently receiving inhaled tobramycin/TOBI
* A septic or clinically unstable patient, as determined by the investigator.
Dynamic Management of Excess Residual Limb Pressure With New Smart Socket Technology/Intelligent Prosthetic Socket With Variable Volume and Elevated Vacuum Systems

This study centers around the imaging of internal structures of residual limb by means of modern radiographic imaging techniques (Dynamic Radiography-DRSA).

The purpose of our research is to further study the behavior of bones and soft tissue of the socket-stump interface during dynamic tasks such as walking or brisk walking. In the long term this research could prove a basis for improvements in the general design of sockets for the new generation of prosthetic devices.

There is very little known about the dynamic conditions inside a prosthetic socket, despite several research efforts based on pressure sensors, static X-ray images and/or computer simulations (FEM). The man reason is the inability of current measuring devices to track with enough resolution the in-vivo high speed kinematics of the stump-socket interface. Socket manufacturing and rectification in the field still relies on the experience and skill of the technician and feedback from the patient. This results in considerable dissatisfaction among the users and poor quantification of the socket fitting problems.

For lower extremity amputees, a well-fitting socket is an important element for a successful rehabilitation. The socket provides the interface between the prosthesis and residual limb, which is designed to provide comfort, appropriate load transmission, and efficient movement control. Attaining these objectives is extremely challenging, with up to 55% of lower limb amputees reporting dissatisfaction with socket comfort, residual limb pain, and/or skin breakdown. In addition, current techniques used to produce sockets with suitable characteristics are labor and cost intensive, and depend on the work of skilled prosthetists that are relatively scarce compared to the number of amputees. Currently, there are more than 500,000 lower limb amputees in the U.S. alone, with 60,000 new ones every year. For upper extremity amputees the issues related to the efficiency of movement, load transmission and comfort become even more challenging due to the different nature of the associated motor skills and performing tasks. Similarly there are l7,350 annual upper limb amputations distal to elbow in individuals under 21 years of age in the US. In most developed countries there are 1.55 amputees per 1000 people. Most amputees wear a prosthesis for about 70 hr/week and use crutches or wheelchairs as alternative assistive devices when performing certain tasks. Current solutions do not meet the patient specific needs.

It is suggested that our findings can further the understanding of the effects of slippage or harmful relative motion between stump and socket. Eventually new - and scientific based - guidelines for the fitting of artificial limbs could be recommended.

Eligibility Criteria:
Inclusion Criteria:

* trans-tibial amputation, proficiency in prosthesis use

Exclusion Criteria:

* pregnancy, balance impairment, stump skin breakdown
Diagnosis of ON With or Without MS or NMOSD

This is both a prospective and retrospective study of patients with a known diagnosis of optic neuritis (ON) only, multiple sclerosis (MS) with ON, or neuromyelitis spectrum disorder (NMOSD) with ON. There will be no requirement for blinding (patient or assessor) and data collected with the Reflex app will be compared against other data that track optic nerve functional status, such as optical coherence tomography (OCT), visual fields (VF), low-contrast sensitivity, MRI orbits/brain and visual evoked potentials (VEP). Patients who have any diagnosis of ON, with or without a diagnosis of MS or NMOSD and who have had testing using other modalities such as VEPs, VF, low-contrast sensitivity studies, OCT, and MRI of brain or orbits will be included as retrospective subjects in the study. In this cohort, RAPD assessments will be completed and compared to against the data that has accrued as noted.

The purpose of this research is to gather information on whether using quantitative- or numerical measurements of pupil changes as an alternative to qualitative- or observation based- testing can be done to assess optic nerve dysfunction in ON, MS with ON, and NMOSD with ON. One way this is done is through evaluating relative afferent pupillary defect (RAPD), which is a clinical sign that is used to detect an injury or defect in the pupil's pathway and this often involves the retina of the eye, which focuses light, and the optic nerve, which sends visual information to the brain. When shining a light into each eye, the eye with RAPD shows a slowed response to light, and when the light moves to the normal eye, the pupil of RAPD eye will dilate. Observational evaluations of RAPD are very common in clinical neurology to detect these optic nerve diseases. As technology has advanced, to lessen the observation errors, numerical measurement of RAPD is now possible through a web based app called Reflex (Brightlamp Inc., Purdue University), which is a FDAapproved class I regulated medical device. In this study, the investigator will compare the results of a participant's app recording to other data that has been collected which also tracks optic nerve function status.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients ages 18-90 years
2. Signed informed consent
3. Have been diagnosed with optic neuritis (ON) only, MS and ON, or NMOSD and ON
4. Have had at least one previous test to track optical nerve function

Exclusion Criteria:

1. Are pregnant or nursing
2. Are children (age \<18 years)
3. Do not have a diagnosis of optic neuritis (ON)
4. Have a diagnosis of MS or NMOSD without a diagnosis of ON as well
The Analysis of Correlation About the Spot Urine Sodium and the Blood Pressure in General Population According to the Income Level

Increasing sodium intake raises blood pressure. And high salt intake could hinder the management of chronic disease. Much previous research has confirmed that dietary habits are affected by economic status. So we compared sodium intake with economic status. We investigated the prevalence, extent and management, and the relevance of sodium intake with income level.


Eligibility Criteria:
Inclusion Criteria:

* all the patient who participated in the national survey

Exclusion Criteria:

* no pregnancy
* malignancy
A Mammography FastTrack Program in Increasing the Number of Women Undergoing Breast Cancer Screening

RATIONALE: Screening may help doctors find breast cancer cells early and plan better treatment for breast cancer. The Mammography FastTrack program may be effective in increasing the number of patients who undergo mammography.

PURPOSE: This randomized clinical trial is studying the use of a Mammography FastTrack program to increase the number of women who undergo mammography.

OBJECTIVES:

* Classify all patients within the Massachusetts General Primary Care-Practice Based Research Network (MGPC-PBRN) according to patient-primary care provider (PCP) linkage status.
* Develop a breast cancer screening intervention program called Mammography FastTrack that facilitates the ordering of mammograms to be used either by PCPs (for PCP-linked patients) or by practice managers (for practice-linked patients).
* Compare the impact of the Mammography FastTrack program on mammography screening rates in PCP-linked vs practice-linked patients overdue for breast cancer screening.

OUTLINE: This is a randomized, multicenter study.

Mammography-eligible women are linked to either a provider or a practice within the Massachusetts General Primary Care Practice-Based Research Network (MGPC-PBRN). Practices within the MGPC-PBRN are stratified according to baseline mammography screening rates (high vs low) and practice type (community health center vs hospital-based vs community-based) and are randomized to 1 of 2 arms.

* Arm I: Physicians and practice managers receive e-mail alerts at months 1 and 3 informing them of the availability of mammography screening data for their panel of primary-care patients. A hyperlink refers the provider to a web-portal for the Mammography FastTrack program that lists all eligible patients who have not undergone mammography. The provider may then click a button to schedule, defer (providing reason for deferral), or provide the date of a recent mammogram.
* Arm II: Practices continue standard care. At the end of 12 months, electronic report and billing data and a review of electronic health records are used to determine the completion of mammograms.

PROJECTED ACCRUAL: A total of 6,730 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Any outpatient at a participating Massachusetts General Primary Care Practice-Based Research Network (MGPC-PBRN) practice within the past 3 years

  * No patient who the Massachusetts General Hospital system lists as having a primary care provider who is not in one of the MGPC-PBRN networks (linking patients with a provider or practice)
  * No patient who is not linked to specific provider or practice (randomized portion of study)
* Billing, scheduling, and clinical electronic data sources required
* No mammogram within the past 2 years (randomized portion of study)
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Age 42 to 69 years (randomized portion of study)
* Female
* Menopausal status not specified

PRIOR CONCURRENT THERAPY:

* No prior bilateral mastectomy (randomized portion of study)