cyrilzakka/clinical-trials huggingface dataset:
Classification of COVID-19 Infection in Posteroanterior Chest X-rays

The objective of this study is to assess three configurations of two convolutional deep neural network architectures for the classification of COVID-19 PCX images.

The December 2019 outbreak of COVID-19 has now evolved into a public health emergency of global concern. Given the rapid spread of infection, the rapid depletion of hospital resources due to high influxes of patients, and the current absence of specific therapeutic drugs and vaccines for treatment of COVID-19 infection, it is essential to detect onset of the disease at its early stages. Radiological examinations, the most common of which are posteroanterior chest X-ray (PCX) images, play an important role in the diagnosis of COVID-19. The objective of this study is to assess three configurations of two convolutional deep neural network architectures for the classification of COVID-19 PCX images. The primary experimental dataset consisted of 115 COVID-19 positive and 115 COVID-19 negative PCX images, the latter comprising roughly equally many pneumonia, emphysema, fibrosis, and healthy images (230 total images). Two common convolutional neural network architectures were used, VGG16 and DenseNet121, the former initially configured with off-the-shelf (OTS) parameters and the latter with either OTS or exclusively X-ray trained (XRT) parameters. The OTS parameters were derived from training on the ImageNet dataset, while the XRT parameters were obtained from training on the NIH chest X-ray dataset, ChestX-ray14. A final, densely connected layer was added to each model, the parameters of which were trained and validated on 87% of images from the experimental dataset, for the task of binary classification of images as COVID-19 positive or COVID-19 negative. Each model was tested on a hold-out set consisting of the other 13% of images. Performance metrics were calculated as the average over five random 80%-20% splits of the images into training and validation sets, respectively.

Eligibility Criteria:
Inclusion Criteria:

* Single PCX images collected from patients over 18 years of age

Exclusion Criteria:

* CT scans composed of multiple concerted X-rays
* Single PCX images collected from patients under 18 years of age
This Study Will Evaluate Efficacy and Safety of Deferasirox in Patients With Myelodysplastic Syndromes (MDS), Thalassemia and Rare Anemia Types Having Transfusion-induced Iron Overload.

This study will evaluate the efficacy and safety of deferasirox in patients with MDS, thalassemia and rare anemia patients with transfusion iron overload.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 2 years
2. Primary Diagnosis: Myelodysplastic Syndrome (presenting with low or intermediate-1 IPSS risk), thalassemia or rare anemias patients (anemia Diamond-Blackfan, Fanconi's anemia, Sideroblastic anemia, Red cell aplasia)
3. ECOG Performance Status ≤ 2
4. Transfusion overload confirmed with ferritin level \>1000 µg/l.
5. No severe concomitant uncontrolled disease (uncontrolled diabetes mellitus, heart failure, renal failure).
6. Serum creatine level \> ULN
7. No proteinuria
8. Liver enzymes level \< 5 ULN.
9. No pregnancy or lactation
10. Signed informed consent by adults. In case inclusion of children under 18 years old, the informed consent should be signed by parents.

Exclusion Criteria:

1. Age \< 2 years
2. No iron overload (Ferritin level \<1000 µg/l).
3. Primary iron overload (hereditary hemochromatosis)
4. Severe concomitant disease (uncontrolled diabetes mellitus, heart failure, renal failure)
5. Elevated serum creatinine \> ULN or/and proteinuria
6. Liver enzymes level \>5 ULN.
7. Pregnancy or lactation.

Other protocol-defined inclusion/exclusion criteria may apply
Evaluation of the Parietex TM Parastomal No Hole Mesh for Repair of Parastomal Hernias in End-colostomies

Short Title: PHARAOH study: LAPAROSCOPIC PARASTOMAL HERNIA REPAIR WITH A NO HOLE MESH.

Objectives:

Evaluation of operative complications, colostomy function, Quality of Life and recurrence rate after laparoscopic repair of parastomal hernias in end-colostomies with a ParietexTM Parastomal No Hole mesh.

Principle Investigators:

Prof. Dr. Frederik Berrevoet, University Hospital Ghent Dr. Filip Muysoms, AZ Maria Middelares Ghent

Patient selection:

Adult consecutive patients, men or women, aged above 18, planned for primary elective laparoscopic hernia repair of an end-colostomy. A logbook will be kept of adult patients undergoing a parastomal hernia repair in the participating centers during the study period that are not entered in the study, including the reason for non inclusion. A total of 100 patients will be included during 24 months or until the sample size has been reached.

Exclusion criteria: previous repair of a parastomal hernia at the same site, emergency operations, open parastomal hernia repair, parastomal hernias at an ileostomy or an ileal conduit stoma, loop colostomies, patients under the age of 18 years, pregnant women, ASA score 4 or more, no informed consent of the patient, patients unable to complete the stoma Quality of Life assessment.

Primary Endpoint:

Evolution of Quality of Life with the Stoma-QoL score assessment of patients: preoperatively, at 1 month, 12 months and 24 months postoperatively.

Secondary Endpoints:

Quality of Life of the patients with the EuraHS QoL score: preoperatively, at 1 month, 12 months and 24 month postoperatively. Recurrence rate at 12 and at 24 months postoperatively evaluated by clinical examination and if available computer tomography. Intra-operative and post-operative complications, post-operative hospital stay, operation time.

Primary Endpoint:

Evolution of Quality of Life with the Stoma-QoL score assessment of patients: preoperatively, at 1 month, 12 months and 24 months postoperatively.

Secondary Endpoints:

Quality of Life of the patients with the EuraHS QoL score: preoperatively, at 1 month, 12 months and 24 month postoperatively. Recurrence rate at 12 and at 24 months postoperatively evaluated by clinical examination and if available computer tomography. Intra-operative and post-operative complications, post-operative hospital stay, operation time.

Eligibility Criteria:
Inclusion Criteria:

- adult patients, planned for primary elective laparoscopic hernia repair of an end-colostomy.

Exclusion Criteria:

* previous repair of a parastomal hernia at the same site
* emergency operations
* open parastomal hernia repair
* parastomal hernias at an ileostomy or an ileal conduit stoma
* loop colostomies
* patients under the age of 18 years
* pregnant women
* ASA score 4 or more
* no informed consent of the patient
* patients unable to complete the stoma Quality of Life assessment
Home-based Exercise Program With Smart Rehabilitation System

A lot of patients suffer the balance and gait disorders after stroke. Many rehabilitation therapies have been provided to improve the balance and gait function in stroke patients. However, most rehabilitation therapies are performed in only hospitals, in spite of the difficulty of moving from home to hospitals for stroke patients. Home-based smart rehabilitation system (Uincare®, D-gate Co.) can provide the specific rehabilitation training program to stroke patients in their home. This study aims to investigate the effects of the home-based exercise program with smart rehabilitation system on balance and gait functions in stroke patients.

The total 100 patients with stroke will be divided into each the intervention group and the control group. The intervention group will be provided the home-based smart rehabilitation system for 4 weeks, and the control group will be educated the conventional home rehabilitation exercise at once. The immediate effects of the home-based smart rehabilitation system on the balance and gait function will be assessed at 4 weeks after exercise and the long-term carry-over effects will be also assesed at 4 weeks after cessation of exercise.

Eligibility Criteria:
Inclusion Criteria:

* adult stroke patients (more than 18 years old)
* less than 6 months after stroke onset
* discharged to home or the plan to discharge to home less than 3 days
* independent ambulatory function on even level (4 or more than 4 in Functional Ambulatory Category)

Exclusion Criteria:

* Advanced liver, kidney, cardiac, or pulmonary disease
* A terminal medical diagnosis consistent with survival \< 1 year)
* Pre-existing and active major neurological disease
* Pre-existing and active major psychiatric disease
* Severe language disorders
* Severe cognitive disorders (10 or less than 10 in K-MMSE)
A Novel Intertransverse Plane Block: a Magnetic Resonance Imaging and Volunteer Study

Intertransverse process block (ITPB) is a thoracic nerve block technique where the LA is injected into the thoracic "intertransverse tissue complex" posterior to the superior costotransverse ligament (SCTL). It may be an attractive alternative to a TPVB for unilateral surgery on the thorax, when considering the risk for pleural puncture, since it does not require direct needle access to the thoracic paravertebral space. However, although ITPB is ultrasound guided, the LA is frequently injected using surrogate bony landmarks in the sagittal sonogram, and in most cases without even identifying the SCTL.

The knowledge regarding the spread of local anesthetic is a major prerequisite for a safe and effective use of all regional anesthetic methods in clinical practice. The primary outcome is the spread of injectate which will be evaluated on axial three-dimensional MRI with contrast medium. The secondary outcome is the sensory dermatomal blockade of this novel ITPB block.

Eligibility Criteria:
Inclusion Criteria:

* healthy Thai men with no diseases

Exclusion Criteria:

* inability to cooperate or communicate in Thai
* BMI ≥ 30 kg/m2 or body weight ≤ 45 kgs
* allergy to local anesthetics or contrast agents
* infection in the block area
* previous surgery or anatomical abnormalities of thoracic spines closed to block area
* coagulation disorder/thrombocytopenia/anticoagulation therapy
* contraindications to magnetic resonance imaging (MRI) (metal implants - pacemaker and others, claustrophobia)
Visceral Artery Aneurysm Embolization by the Penumbra Ruby™ Coil System

The primary objective of this study is to gather post market data on the Penumbra Ruby Coil System in the treatment of visceral artery aneurysms and arteriovenous malformations. This study is a prospective, multi-center study of patients with visceral artery aneurysms and visceral arteriovenous malformations who are treated by the Penumbra Ruby Coil System. Data for each patient are collected up to 12 months post-procedure for the study.


Eligibility Criteria:
Inclusion Criteria:

* Patients enrolled in this study must be those treated according to the cleared indication for the Penumbra Ruby Coil System for visceral arterial and venous embolizations.

Exclusion Criteria:

* Patients in whom endovascular embolization therapies other than Penumbra Coils are used will be excluded from this study.
Utilization of the TAD Device for Dispensing Pain Medications in Hospice Patients

A novel device, TAD, has been developed to aid adherence to prescribed regimens and may have a roll in hospice pain management. This study aims to assess medication adherence relating to missed doses or improperly timed doses with and without the aid of a mobile device as a primary endpoint. Secondary endpoints will be patient, nursing, and provider satisfaction.

This study is a randomized crossover study in which patients will be randomized to start with or without a mobile device assisting the patient or caregiver in using the device. The investigators aim to enroll 20 patients across 3 sites. Each patient is expected to participate in the study for 12 weeks. After the first 2 weeks of participation, the patient will either begin using the mobile device to assist or will stop using the mobile device for the next 2 weeks. after the initial 4 weeks, the patient will choose to continue with or without using the mobile device.

Eligibility Criteria:
Inclusion Criteria:

* any patient taking morphine ER or Oxycontin on one of three hospice home teams

Exclusion Criteria:

* pregnancy
* inability to demonstrate competent use of the device
* age less than 18
Therapeutic Instrumental Music Performance With Sensory-Enhanced Motor Imagery in Chronic Post-Stroke Rehabilitation

Research has shown that music engages the brain bilaterally throughout cortical and subcortical regions, accessing extended sensorimotor, cognitive and affective networks. This research explores the hypothesis that use of these shared neural networks allows neurologic music therapy interventions targeting upper extremity motor control to promote plasticity and functional improvements in persons recovering from a cerebrovascular accident. The potential therapeutic benefits of these interventions on attentional processes and affective responding will also be examined.

More individuals are surviving and living with the effects of stroke, a trend that is expected to continue. Upper extremity limitations present a common, persistent challenge for stroke survivors, impacting quality of life. In addition, links have been found between physical impairment and depression, and depression and stroke-induced cognitive impairment. Music has been shown to exert multimodal effects on individuals and may be used as a mediating stimulus to promote therapeutic change. Furthermore, motor imagery may enhance the effectiveness of upper extremity interventions by engaging the same brain areas that are active in physical movement. The purpose of this study is to investigate the effects of therapeutic instrumental music performance and sensory-enhanced motor imagery on upper limb movement, affect and cognition following a stroke. Participants will be assessed at two baselines, and randomly assigned to one of three intervention groups: therapeutic instrumental music performance, therapeutic instrumental music performance and sensory-enhanced motor imagery, or therapeutic instrumental music performance and motor imagery without sensory enhancement.

Eligibility Criteria:
Inclusion Criteria:

* hemiparesis following a unilateral stroke (hemorrhagic or ischemic), sustained more than 6 months prior, with at least minimal volitional movement of the affected limb
* permission from a physician to participate in an upper extremity rehabilitation program, including confirmation that the following disorders are not present: rheumatoid arthritis, upper extremity fracture, apraxia, neuropathy, somatosensory impairment
* adequate language comprehension and neurocognitive function to understand and follow simple instructions

Exclusion Criteria:

* currently enrolled in an upper extremity rehabilitation program or another upper extremity study
* comorbid neurological disorder (e.g. multiple sclerosis, Parkinson's disease)
* evidence of perceptual or cognitive impairment; e.g., unilateral spatial neglect, significant hearing impairment, Montreal Cognitive Assessment score of 25 or less
* presence of aphasia
* injections for spasticity within three months of participation
Daily Protein Intake Patterns on Energy Metabolism and the Motivation to Snack

The purpose of this study is to determine if when one eats protein can change how the body uses food for energy. Researchers will also test if eating a high protein breakfast can change one's craving for snack foods.

The purpose of this study is to determine if consuming 30 g of high-quality protein at each meal can increase fat utilization and shift between-meal snack choices. While the benefits of high-protein diets are well known, little is known about the optimal amount of protein that should be eaten at each meal. Most Americans eat little protein at breakfast and lunch and most of their protein at the evening meal. Current guidelines for protein are based on body weight; however, recent evidence indicates that absolute amounts of protein at each meal are needed to maintain metabolically active fat-free mass. This suggests that a more even protein consumption pattern across daily meals may positively influence energy metabolism. In addition, recent evidence indicates that protein may reduce activity in the food reward areas of the brain. This suggests that protein may influence between-meal snacking by decreasing the relative reinforcing value (RRV) of highly rewarding snack foods. The RRV of a food is an empirical measure of its motivating value and energy-dense foods are highly reinforcing, especially for obese individuals. This study will be the first to investigate the role of the daily distribution of protein intake on energy metabolism and modifying snacking behavior.

Eligibility Criteria:
Inclusion Criteria:

* BMI \< 25 kg/m2
* BMI ≥ 30 kg/m2 but \< 34.5 kg/m2
* able to understand and sign the informed consent
* able to provide own transportation to the Center
* free of any major illness/disease
* usual protein intake within the acceptable macronutrient distribution range (10 to 30%)
* constant habitual activity patterns within the last 3 months
* females of childbearing age must be on birth control for a minimum of 3 months prior to study start and have regular menstrual cycles

Exclusion Criteria:

* unable or unwilling to consume animal products
* have had more than a 10% change in body weight within the past 2 months
* are participating in a weight loss diet/exercise program
* are consuming a specialized diet
* currently or planning on becoming pregnant during the study timeline
* lactating
* have a metabolic illness/disease
* have uncontrolled hypertension
* have ever had cancer
* have an infectious disease
* suffer from alcohol or drug abuse
* use tobacco and e-cigarette products on a regular basis
* have the presence of acute illness
* taking medications known to affect energy expenditure and appetite
The Effect of Reflexology on Radiation-related Fatigue in Breast Cancer Patients

Oncologic patients often report increased fatigue during and after radiation therapy. Reflexology treatment has been demonstrated to alleviate symptoms of fatigue, nausea, and anxiety in oncologic patients treated with chemotherapy. The aim of the study is to evaluate the effect of reflexology on fatigue, quality of life, and quality of sleep of breast cancer patients during and after radiation therapy.

Reflexology (foot massage) is a complementary medicine technique which is performed by manual pressure on specific areas of the feet. Reflexology is based on a system of zones and reflex areas that are believed to reflect an image of the body on the feet with a premise that such work effects a physical change to the body.

The effect of reflexology on fatigue, quality of life, and quality of sleep of 20 breast cancer patients during and after radiation therapy will be compared to age-matched control group of 20 breast cancer patients treated by radiation therapy.

Eligibility Criteria:
Inclusion Criteria:

* Breast cancer adult patients scheduled to receive adjuvant radiation therapy

Exclusion Criteria:

* Open wounds or evidence of metastases on the lower limbs
* Touch therapy or other complementary therapy other than intervention procedure
Intrapartum Maternal Oxygen Supplementation: Effects on the Mother and Neonate

Approximately 2/3 of laboring women receive supplemental oxygen (O2) in an attempt to reverse perceived fetal hypoxia on electronic fetal monitoring (EFM). O2 supplementation is most commonly used in patients with Category II EFM, a class of EFM patterns designed in part to identify fetal acidemia. This liberal use of O2 in laboring patients is concerning because hyperoxygenation in infants is associated with adverse outcomes including retinopathy and abnormal neurodevelopment. Furthermore, excess O2 exposure is linked to free radical generation and subsequent oxidative cell damage. This calls for a closer look at the safety of intrauterine O2 exposure. The proposed project explores potential mechanisms for harm with maternal O2 supplementation in laboring patients with Category II EFM. Specifically, this project will determine the effect of O2, compared to room air (RA), on umbilical cord and maternal levels of malondialdehyde (MDA) and 4-hydroxynonenal (4-HNE), markers of free radical-induced oxidative stress. The study will also explore the correlation between urinary and blood markers of oxidative stress. Banked specimens will be used to investigate the potential effect of peripartum O2 exposure on placental oxidative stress in the future.


Eligibility Criteria:
Inclusion Criteria:

* Singleton
* Gestational age ≥37 weeks
* Spontaneous labor or induction of labor
* English speaking
* Ability to give informed consent

Exclusion Criteria:

* Major fetal anomaly
* Multiple gestation
* Category III electronic fetal monitoring
* Maternal hypoxia
* Preeclampsia
* Intrauterine growth restriction
* Pregestational diabetes
* Tobacco use
Gene Therapy for IGHMBP2-Related Diseases

Open-label, single intrathecal injection study of a AAV9 vector carrying the IGHMBP2 gene for IGHMBP2-related diseases.


Eligibility Criteria:
Inclusion Criteria:

* Confirmation of two pathogenic variants in the IGHMBP2 gene from a CLIA-certified lab
* Pre-ambulant (not yet walking and less than 18 months) or ambulant (as defined by the ability to walk 10 meters without assistance) or non-ambulant (inability to walk more than 10 meters unassisted)
* Ability to cooperate with functional assessments as per PI's discretion

Exclusion Criteria:

* Prior participation in a gene or cell therapy program for any kind.
* Immunizations of any kind in the month prior to the study.
* Active infection based on clinical observations
* Serological evidence of HIV infection, or Hepatitis B or C infection
* Diagnosis of (or ongoing treatment for) an autoimmune disease
* Persistent leukopenia or leukocytosis (WBC ≤ 3.5 10\^3/μL or ≥ 20.0 10\^3/μL) or an absolute neutrophil count \< 1.5 10\^3/μL
* Abnormal liver function as indicated by an elevated GGT (\>2X normal if no other laboratory abnormalities), bilirubin and/or abnormal PT/INR
* Concomitant illness or requirement for chronic drug treatment that in the opinion of the PI creates unnecessary risks for gene transfer
* AAV9 binding antibody titers \> 1:50 as determined by ELISA immunoassay performed by Athena Diagnostics
* Abnormal laboratory values in the clinically significant range, based upon normal values in the Nationwide Children's Hospital Laboratory
* Diagnosis of any other systemic illness that increases the risk of gene transfer per the PI's opinion; Has a medical condition or extenuating circumstance that, in the opinion of the PI, might compromise the subject's ability to comply with the protocol required testing or procedures or compromise the subject's well-being, safety, or clinical interpretability
* Any requirement for immune modulatory therapy and for which it would be unsafe for the subject to undergo an appropriate wash out period
* Contraindication for intrathecal injection
* A positive JCV antibody test of \>0.40