cyrilzakka/clinical-trials huggingface dataset:
3D Printing for Nodule Localization

Implementation of lung cancer screening using low-dose computed tomography has increased the rate of detection of small peripheral pulmonary nodules. However, it is hard to localize these nodules by palpation because of their small volume and long distance to the nearest pleural surface. To further clarify the confounding factors, we developed our own 3D printing localization procedure. In contrast to traditional CT-G percutaneous puncture localization, our procedure was performed in the operating room without CT scan evaluation.

Pulmonary wedge resection is one of the most common types of operations performed by thoracic surgeons, especially given that more and more patients with ground glass nodules are being detected recently. One of the most significant current discussion concerning wedge resection is nodule localization. At present, a commonly used localization method is the CT-guided percutaneous lung puncture methylene blue staining marker localization, but this method has two main disadvantages: 1. the methylene blue dye is easy to spread, affecting the intraoperative judgment of nodule position by surgeon; 2. patients often suffer additional CT radiation. In recent years, the three-dimensional (3D) printing technique has been gradually applied to clinical therapy. However, 3D-printed template-guided (3D-G) localization required pre-evaluation by CT scanning. If deviation of more than 2 cm was found on the CT scan, the 3D-G method was regarded as a failure and traditional CT-G hookwire localization was used. To further clarify the confounding factors, the investigators developed their own 3D printing localization procedure. In contrast to traditional CT-G percutaneous puncture localization, the 3D printing localization procedure was performed in the operating room without CT scan evaluation.

Eligibility Criteria:
Inclusion Criteria:

* a maximum target lung nodule diameter ≤20 mm;
* a target nodule consolidation/tumor ratio (CTR) \<0.25, or a minimum distance from the outer edge of the nodule to the nearest pleural surface \>10 mm if the target nodule CTR was \>0.25.

Exclusion Criteria:

* Inability to comply with research protocols or research procedures
* Any unstable systemic disease (including active infections, uncontrolled high blood pressure, unstable angina, angina pectoris that has started within the last 3 months, congestive heart failure (≥ New York Heart Association \[NYHA\] Level II ), cardiac infarction (6 months before enrollment), severe arrhythmia requiring medication, liver, kidney or metabolic disease
* Active bleeding; Inability to withstand lying flat; Inability to cooperate through breathing during puncture
* Pregnant or lactating women
* Other circumstances that the investigator believes are not suitable for enrollment
Evaluation of Executive Function With Virtual Reality Among People With Schizophrenia

This Cross-sectional Study Included Patients that diagnosed with schizophrenia, aged 18-55, 20 of which hospitalized in mental health department and 20 in medical follow-up.

Different test will be administered, in two or three sessions, to evaluate cognitive ability, function ability and participation.

The results of the VIS shopping task performance (statically \& dynamically) and its correlation with the cognitive and function tests as well as the participation questionnaire will be examined. These findings will indicate whether the shopping task is valid to assess executive functions for people with schizophrenia and whether it is ecologically valid.

Background:

Schizophrenia often reflect by decrease in executive functions that may cause difficulty in Instrumental Activities of Daily Living (IADL). We've found it very difficult to simulate these functions with the existing tools in the clinic and to assess IADL accordingly.

The use of Virtual Reality (VR) became popular in the last decade to overcome these limitations in clinical practice and assessment of functioning in IADL. VR is a computer program that simulates a functional environment in which the subject impacts on events through various actions. Recent studies indicated that VR can be used to assess cognitive abilities and functioning of population with schizophrenia. As far as we know, no researches were performed using Virtual Interactive Shopping (VIS) in this population, nor did dynamic evaluation was used to identify potential learning abilities. The aim of this study is to examine the validity of the shopping task in the VIS, performed statically and dynamically, in order to assess executive function, and the ability to reflect cognitive, functional and participation ability among people that diagnosed with schizophrenia.

Method:

This Cross-sectional Study Included Patients that diagnosed with schizophrenia, aged 18-55, 20 of which hospitalized in mental health department and 20 in medical follow-up.

Different test will be administered, in two or three sessions, to evaluate cognitive ability, function ability and participation.

The results of the VIS shopping task performance (statically \& dynamically) and its correlation with the cognitive and function tests as well as the participation questionnaire will be examined. These findings will indicate whether the shopping task is valid to assess executive functions for people with schizophrenia and whether it is ecologically valid.

Eligibility Criteria:
Inclusion Criteria:

* Schizophrenia or Scizoeffective diagnosis, Hebrew language proficiency, three weeks of anti-psychotic drug treatment

Exclusion Criteria:

* score of under 70 in the 3MS (screen test), physical disability, neurological diagnosis (ex. dementia)
Trauma Heart to Arm Time

In the prehospital setting it would be helpful to assess primary changes in central blood volume or preload (venous return, stroke volume, diastolic ventricular volume) that occur during the stability phase following injury when regulatory mechanisms are still functioning.

Obviously in this setting a non invasive bedside beat-to-beat index would be helpful.

Pulse Transit Time (PTT) is the sum of Pre-Ejection Period (PEP), the time interval between the onset of ventricular depolarization and the ventricular ejection, and Vascular Transit Time (VTT), the time it takes for the pulse wave to travel from the aortic valve to the peripheral arteries (Obrist et al. 1979). PEP variations are known to correlate with reductions in central blood volume induced by head-up tilt (Chan et al., 2007b, 2008). The same authors also demonstrated that PTT variations follow closely PEP variations and therefore central blood volume variations (Chan et al., 2007b). Following central blood volume reductions induced by head-up tilting ventricular diastolic filling time increases involving an increase in PEP and PTT. Chan et al. (Chan et al., 2007b) concluded that PTT could have been used to assess early central hypovolemia and suggested that joint analysis of PTT and RR intervals could help in predicting the extent of blood volume loss. The investigators hypothesized that sympathetic drive associated with trauma would act on cardiac contractility through beta activity thus shortening PTT without reducing RR interval to the same extent in healthy hearts. We also hypothesized that progressive hypovolemia would lead to a rising of PTT (augmented diastolic filling time) and a RR interval shortening (relative tachycardia). In this study the investigators propose and index based on the beat-to-beat PTT/RR ratio to assess central hypovolemia in traumatic patients enrolled by our Helicopter Emergency Medical System (HEMS) in a prehospital setting.


Eligibility Criteria:
Inclusion Criteria:

* all trauma victims enrolled by our Helicopter Emergency Medical System (HEMS)

Exclusion Criteria:

* need of immediate life-saving manoeuvres as decided by onboard physician following Prehospital Trauma Care (PTC) criteria (CITATION PTC)
* Cardiac arrest
* presence of preexisting chronic illnesses involving the autonomic nervous system such as hypertension, diabetes and any neurological disease
* any preexisting medical therapy including those administered by the emergency medical team as defined in point 1)
* presence of supraventricular ectopic beats more than 5% of total recorded beats
* absence of sinus rhythm
* presence of intraventricular or bundle branch blocks or artificial pacemaker
* spinal chord trauma above D2
* patient age \<18 years
* presence of burns not allowing monitoring
Preoperative Chlorhexidine Gluconate (CHG) Cloth on Healthy Subjects

Evaluate the effects of Chlorhexidine Gluconate (CHG) cloth on the reduction of bacteria on the skin.

Examine the antimicrobial cloth effects on normal flora bacteria of the abdomen and groin areas post CHG application.

Eligibility Criteria:
Inclusion Criteria:

* Males or Females
* 16 years of age or older
* Signed informed consent
* Good Health
* Six inches of abdomen and groin areas without tattoos, or skin disorders

Exclusion Criteria:

* Dermatological Conditions
* Sensitivity to latex
* Sensitivity to CHG
Bridging the Gap: Using Video Art to Document the Human Face of Disease & Predict Quality of Life Assessments in Brain Tumor Patients

The goal of this study is to explore whether facial expression changes in visual portraits correlate with Quality of Life (QOL) questionnaire responses before and after pet therapy sessions and to compare scores of QOL questionnaires before and after pet therapy.

Through this pilot study, the investigators propose to create new intersections between video art and clinical care by photographing and videotaping patients with brain tumors before, during and after pet therapy sessions. This exploratory scholarship has two equally compelling goals. First, the artistic component of the project aims to create compelling slow motion video portraits of patients' willing to share their experiences of what it is like to confront such a grave illness. The goal is to put a human face on disease and share the endurance of the human spirit through art. Second, the scientific component will assess the potential of using facial video portraits as a novel and innovative way to measure Quality of Life (QOL) in lieu of questionnaires in brain tumor patients. In addition, the project will evaluate the effects of pet therapy on the QOL of these patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with brain tumors
* Willingness to participate in a brief pet therapy session with a dog
* Willingness to allow photographs, pictures and audio used in an art exhibit

Exclusion Criteria:

* Allergy to dogs
* Concurrent disease or condition that would make the patient inappropriate for study participation or any serious medical or psychiatric disorder that would interfere with the subject's safety
Medial Peel Release Technique TKA Randomized Clinical Trial

Medial subperiosteal release is a commonly performed technique to improve surgical exposure and aid in joint balancing. This is a routine step during primary total knee arthroplasty that will be conducted on every enrolled patient. This is commonly performed both via scalpel (aka sharp medial peel) or electrocautery. The intervention will be randomly assigning subjects undergoing TKA into two groups, one receiving subperiosteal release using a scalpel (aka sharp medial peel) and the other via electrocautery.

Medial release is a commonly performed technique to improve surgical exposure and aid in joint balancing. It is thought to be linked to the postoperative incidence of pes bursitis. However, the effect of scalpel vs electrocautery techniques for subperiosteal release has not been examined for their potential effect on the rates of pes bursitis. This randomized clinical trial will assign patients undergoing TKA for osteoarthritis (OA) into either scalpel or electrocautery release groups for their operation and will be followed postoperatively at 3 weeks and 3,6, and 12 months in order to determine the effect of release technique on rates of pes bursitis. This study will take place at Emory Orthopaedics. Subjects will not be compensated. Patients presenting to the clinic for evaluation of TKA will be screened for their eligibility in this study and recruited as well as consented in the clinic. This study can advance current clinical knowledge by evaluating two common surgical techniques to determine which may lead to better outcomes for patients undergoing TKA, a common orthopedic procedure, and reduce dissatisfaction as well as pain following operation.

Eligibility Criteria:
Inclusion Criteria:

* Patients over age 18
* Patients undergoing primary TKA for osteoarthritis

Exclusion Criteria:

* Patients undergoing revision TKA
* Any patients not undergoing TKA for non-OA diagnosis
* Adults unable to consent
* Pregnant women
* Prisoners
Emotional Brain Networks & Cognitive Functioning in Depression and Anxiety

This study aims to 1) examine common and specific emotional and cognitive dysfunctions between Major Depression and generalized anxiety disorder; 2) Examine emotional and cognitive dysfunctions between the two disorders and healthy controls; 3) Examine the biomarkers predicting successful therapy or not.


Eligibility Criteria:
Inclusion Criteria:

* GAD:

  1. Diagnosis of Generalized Anxiety Disorder (GAD) according to DSM V criteria in a structured clinical interview for DSM-V Axis I disorders (SCID I; APA, 2014) and a confirmatory clinical interview
  2. Duration of the current episode \> 3 weeks
* MDD:

  1. Diagnosis of current major depressive disorder in a structured clinical interview for DSM-V Axis I disorders (SCID I; APA, 2014) and a confirmatory clinical interview
  2. Duration of the current episode \> 4 weeks

Exclusion Criteria:

* GAD: diagnosis of any other psychiatric Axis I disorder (except GAD) as a principal diagnosis within the past six months
* MDD: diagnosis of any other psychiatric Axis I disorder (except MDD) as a principal diagnosis within the past six months
Real-World Evidence and Treatment Patterns: Head and Neck Cancer

This study will be focused on HNC patients who have been diagnosed with HNC between 01-Jan-2013 and 30-Sep-2016.


Eligibility Criteria:
Inclusion Criteria:

* HNC or undefined histology (not otherwise specified \[NOS\]) HNC diagnosis from 01-Jan-2013 to 30-Sep-2016 using Japanese disease code
* Age 18 years or older at initial diagnosis of HNC regardless of staging

Exclusion Criteria:

* Diagnosis of another malignancy on or before the initial diagnosis of HNC with the exception of non-melanoma skin cancer and metastatic cancer
* Diagnosis of HNC before 01-Jan 2013 or after 30-Sep-2016
Enhancing Recruitment, Linkage to Care and Treatment for HIV-Infected MSM in the United States

The purpose of this study is to develop and assess the efficacy of an integrated strategy that includes feasible and scalable interventions to identify, recruit, link to care, retain in care, attain, and maintain viral suppression among HIV-infected men who have sex with men (MSM) in the United States (US).

This study will use deep-chain respondent driven sampling (DC-RDS) and direct recruitment (DR) to identify and recruit HIV-infected MSM who are not virally suppressed. A subset of these men will be enrolled into one of two study arms. The intervention arm will provide a Case Manager (CM) intervention package designed to enhance linkage to care, antiretroviral treatment (ART) initiation, treatment adherence and retention in care. The control arm will provide the standard of care (SOC) for linkage to care, initiation of ART, treatment adherence and retention in care. The primary outcome of the study is viral suppression 12 months after enrollment. Phylogenetic methods will be used to evaluate the relationship between viruses in study participants. Mathematical modeling will be performed using demographic, behavioral, and clinical data generated from this study and other sources to estimate the population-level impact of the CM intervention on HIV incidence and to estimate the level of identification, linkage, ART coverage and viral suppression that would be required to achieve a substantial reduction in HIV incidence among MSM in the US settings where the study is conducted.

Eligibility Criteria:
Inclusion Criteria:

Individuals who meet all of the following criteria are eligible for study screening:

* Biological male (at birth)
* Self-report of history of anal intercourse with another man
* 16 years or older

Individuals who are eligible for screening and who meet all of the following criteria are eligible for enrollment into the CM intervention and SOC control arms:

* HIV-infected, as defined in the HPTN 078 Study-Specific Procedures (SSP) Manual
* Not virally suppressed (defined as HIV VL ≥ 1000 copies/ml)
* Can receive HIV care at one of the participating clinics (as chosen by each site)
* No current plan to relocate in the 24 months following enrollment

Exclusion Criteria:

Individuals who meet any of the following criteria will be excluded from study screening:

* Unable or unwilling to provide consent/assent for study participation.
* Active or previous participation in an HIV vaccine trial.
* Any condition that, in the opinion of the Investigator of Record (IoR), would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.

Individuals who are eligible for screening, but who meet the following criteria are excluded from enrollment into the CM intervention and SOC control arms:

• Current participation in a linkage or ART adherence study
Essential Pro PMCF Study ( rEPIC04E )

Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Essential Pro to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with Essential Pro.

The objective of this multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study is to confirm and support the clinical safety and performance of the Essential Pro in a NON-SELECTED, Real World population under daily clinical practice when used as intended by the manufacturer to meet EU Medical Device regulation requirements for post-market clinical follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Patient treated with Essential Pro according to routine hospital practice and following instructions for use
* Informed consent signed

Exclusion Criteria:

• Not meet inclusion criteria
Safety and Efficacy of Mipomersen (ISIS 301012) As Add-on Therapy in High Risk Hypercholesterolemic Patients

The purpose of this study is to evaluate the safety and efficacy of dosing with mipomersen for 26 weeks in patients with high cholesterol who are on a maximally tolerated dose of statin and who have a diagnosis that puts them at least at high risk of coronary heart disease (CHD).

Hypercholesterolemia is characterized by markedly elevated low density lipoproteins (LDL). Elevated LDL is a major risk factor for CHD.

Mipomersen is an antisense drug that reduces a protein in the liver cells called apolipoprotein B (apo-B). Apo-B plays a role in producing low density lipoprotein cholesterol (LDL-C) (the "bad" cholesterol) and moving it from the liver to one's bloodstream. High LDL-C is an independent risk factor for the development of CHD or other diseases of blood vessels. It has been shown that lowering LDL-C reduces the risk of heart attacks and other major adverse cardiovascular events. The purpose of this study is to determine whether mipomersen safely and effectively lowers LDL-C in patients with high cholesterol who are at high risk for CHD and who are already on the maximally tolerated dose of statin.

This study consisted of a 26-week treatment period and a 24-week post-treatment follow-up period. Participants who finished treatment or who discontinued prematurely from the study for any reason were assessed for safety for 24 weeks after the last study drug dose.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of hypercholesterolemia (LDL-C ≥ 100 mg/dL)
* At high risk of CHD
* On stable, maximally tolerated statin therapy for 8 weeks
* On stable, low fat diet for 12 weeks
* Stable weight for 6 weeks

Exclusion Criteria:

* Significant health problems in the recent past including heart attack, stroke, coronary syndrome, unstable angina, heart failure, significant arrhythmia, hypertension, liver disease, cancer, type I diabetes.
Prevention of Lateral Incisional Hernia After Stomal Closure Using P4HB Retro-muscular Mesh

The aim of the study is to determine whether the use of the P4HB retro muscular mesh can prevent the lateral incisional hernia after stomal closure.


Eligibility Criteria:
Inclusion Criteria:

* patients \> 18 y.o.
* stomal closure
* elective surgery

Exclusion Criteria:

* patients \< 18 y.o.
* emergency surgery
Vectors Post Market: A Study to Assess Pain Relief Using Spinal Cord Stimulation

This is a prospective, single-arm, multi-center study evaluating the efficacy of spinal cord stimulation (SCS) therapy for pain relief using high dose (HD) stimulation parameters delivered to neural targets identified during current commercial trial stimulation procedures. The study will evaluate changes in back and leg pain from baseline to 3, 6, and 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Candidate per labeling for an SCS system as an aid in the management of chronic, intractable low back and leg pain
* Presence of low back and leg pain
* Moderate to crippled disability due to pain
* Stable pain medications for back and leg pain for at least 28 days prior to enrollment
* Willing and able to not increase pain medications through the 3-Month visit

Exclusion Criteria:

* Previously trialed or implanted with stimulator or intrathecal drug delivery system
* Current diagnosis of moderate to severe central lumbar spinal stenosis
* Major psychiatric comorbidity or other progressive diseases
* Serious drug-related behavioral issues
* Pregnant or planning on becoming pregnant
* Unable to achieve supine position
Efficacy of Diclofenac Suppository for Pain Control in Ultrasound Guided Biopsy of Prostate

Transrectal ultrasound guided biopsy of prostate (TRUS-Bx) is widely used as accepted mode of investigation for prostate cancer in current urology practice. It is considered a minor procedure, which most of the patients tolerate, however 20% of patients refuse to undergo the redo procedure without any analgesia or anesthesia but on the other hand, some authors reveal that 65 to 90% of patients report pain ranging from mild to severe in intensity. Diclofenac is a local and systemic anti-inflammatory drug and it reduces local mediators involved in local pain.The purpose of this study is to find out the role of rectal administration of diclofenac suppositories as an adjunct to 2% xylocaine gel in alleviating intra and post procedural pain in prostatic biopsy with adequately calculated sample size and excluding the patients with contraindication to procedure or diclofenac administration as these were the shortcomings of previous studies.


Eligibility Criteria:
Inclusion Criteria:All male patients undergoing ultrasound guided prostate biopsy due to any one of the following:

* Raised prostate-specific antigen level (\>4.0ng/ml) and palpable nodularity on digital rectal examination
* Palpable nodularity on digital rectal examination
* Hypo echoic lesion as compared to surrounding prostate on transrectal ultrasound

Exclusion Criteria:

* History of previous prostate biopsy
* Acute and/or chronic prostatitis or chronic pelvic pain syndrome
* Anal fissure, hemorrhoids, anal surgery
* Concomitant analgesic medication
* Chronic renal failure
* Allergy to diclofenac