cyrilzakka/clinical-trials huggingface dataset:
Comparison of Pain-Related Changes in Cerebral Blood Volume in Burn Patients With Neuropathic Pain

The investigators will observe increased or decreased CBV in patients with thermal injury compared with the CBV in healthy controls.

Prevalence of chronic pain has been shown to be high after thermal injury. Post-burn neuropathic pain causes chronic disabilities that is often difficult to treat effectively.

To study changes in the pain network associated with neuropathic pain, magnetic resonance imaging(MRI) will be used to evaluate cerebral blood volume(CBV) in patients who was injuried by burn. Over the fifty participants will be recruited. The participants will be comprised 30 subjects with neuropathic pain caused by thermal injury and 20 healthy contols. The 30 patients with neuropathic pain will be comprised divided into 15 electrical injury group and 15 non-electrical burn injury group. The patients are included the patients with severe neuropathic pain that is rated at least 5 on the visual analogue scale (VAS), despite treatments with gabapentin medication and other physical modalities. The intensity of neuropathic pain will be measured using the visual analogue scale(VAS). Depressive mood will be assessed using the Beck Depression Scale. CBV maps will be compared between burn patients and controls. And the relationship between individual participant CBV(measured in voxels), BDS and VAS score will be also examined.

Eligibility Criteria:
Inclusion Criteria:

* Burn patients
* severe neuropatic pain rated at least 5 on the 10-point numerical rating scale (NRS).

Exclusion Criteria:

* cardiac arrest history
* history of neurologic disease or brain surgery
* unstable heart disease or presence of a cardiac pacemaker
* psychiatric disorder
* diabetes mellitus
* abnormal renal function
* contraindication for MRI
* pregnancy.
Evaluation of the Incidence of Cerebral Lesions Post Pulmonary Vein Ablation Catheter (PVAC)

The purpose of the study is to determine the rate of diffusion weighted (DW)-MRI cerebral lesions following a Pulmonary Vein Ablation Catheter (PVAC) ablation procedure performed using best practices, including optimized procedural techniques and anti-coagulation therapy.


Eligibility Criteria:
Inclusion Criteria:

* Subject is at least 18 years old
* Subject has been diagnosed with atrial fibrillation (AF)
* Subject is indicated for a pulmonary vein ablation using PVAC
* Subject (or subject's legally authorized representative) is able and and willing to give informed consent.

Exclusion Criteria:

* Subject has permanent AF
* Subject has a left atrial thrombus detected on TEE
* Subject has had a prior left atrial ablation
* Subject has a intracardiac thrombus
* Subject is contraindicated for Warfarin (Coumadin)
* Subject has a cardiac valve prosthesis
* Subject has a significant congenital heart defect corrected or not including atrial septal defects or pulmonary vein abnormalities but not including minor PFO)
* Subject has presence of any pulmonary vein stents
* Subject has presence of any pre-existing pulmonary vein stenosis
* Subject has had a cerebral ischemic event (strokes or transient ischemic attacks \[TIA\]) which occurred during the 6 month interval preceding the Consent Date
* Subject is a woman known to be pregnant
* Subject is unwilling or unable to comply fully with study procedures and follow-up
Study to Evaluate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years And Older With Moderate to Severe Atopic Dermatitis

B7451012 is a Phase 3 study to evaluate PF-04965842 in patients aged 12 years and older with a minimum body weight of 40 kg who have moderate to severe atopic dermatitis. The efficacy and safety of two dosage strengths of PF-04965842, 100 mg and 200 mg taken orally once daily, will be evaluated relative to placebo over 12 weeks of study participation. Eligible patients will have an option to enter a long-term extension study after completing 12 weeks of treatment.


Eligibility Criteria:
Inclusion Criteria:

* 12 years of age or older with a minimum body weight of 40 kg
* Diagnosis of atopic dermatitis (AD) for at least 1 year and current status of moderate to severe disease (\>= the following scores: BSA 10%, IGA 3, EASI 16, Pruritus NRS 4)
* Recent history of inadequate response or inability to tolerate topical AD treatments or require systemic treatments for AD control

Exclusion Criteria:

* Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study
* Prior treatment with JAK inhibitors
* Other active nonAD inflammatory skin diseases or conditions affecting skin
* Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q wave interval abnormalities, current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator
* Pregnant or breastfeeding women, or women of childbearing potential who are unwilling to use contraception
Providing an Optimized and Empowered Pregnancy for You (POPPY) Aim 3: Randomized Controlled Trial

The PᵌOPPY study is designed to support the American Heart Association's mission to improve maternal/infant health outcomes and address inequities in maternal/infant health care. The P3OPPY Project is one of five projects within the American Heart Association P3 EQUATE Network. The overarching goal of the P3 EQUATE American Heart Association Health Equity Research Network (HERN) is to promote equity in Maternal and Infant Health outcomes by identifying innovative and cost-effective strategies to enhance access to quality health information, care, and experiences during pregnancy, postnatal and postpartum/preconception periods, particularly for Black and under-served populations. Collectively, the investigators will collaborate with pregnant and postpartum individuals and their families, hospitals, and communities to discover ways to reduce racism and social problems that contribute to poor health outcomes. In this trial, 400 non-Hispanic Black participants will be randomized to see if 2 promising interventions (digital health interventions and community health workers) reduce adverse pregnancy outcomes.

The aim of this trial is to assess whether an existing Digital Heath Intervention (DHI) and/or a Community Health Worker (CHW) Intervention will reduce adverse maternal and perinatal outcomes. A 2 x 2 factorial randomized controlled trial of Non-Hispanic Black (NHB) patients living in high area deprivation index (ADI) communities will be conducted. Participants (n=400) will be randomized 1:1:1:1 to one of 4 arms: 1) standard prenatal care (PNC) alone, or 2) standard PNC plus DHI, or 3) standard PNC plus CHW, or 4) standard PNC, plus DHI and CHW.

The PᵌOPPY study is designed to support the American Heart Association's mission to improve maternal/infant health outcomes and address inequities in maternal/infant health care. The promise of digital health and community health worker engagement makes PᵌOPPY interventions potentially transformative, sustainable, and scalable for Non-Hispanic Black mothers and their infants from under-served communities in Alabama and beyond.

Eligibility Criteria:
Inclusion Criteria:

* Self Identifies as Non-Hispanic Black
* Between 16-49 years old
* Pregnant individuals between 8⁰ - 22⁶ weeks gestational age
* Live singleton or dichorionic twin gestation
* Dating sonogram at \<23 weeks gestation,
* Area Deprivation Index (ADI) National 4th or 5th Quintile
* Planning to deliver at UAB Hospital
* Speaks and writes in English
* No indication for delivery at the time of enrollment

Exclusion Criteria:

* Declines randomization
* Speaks or writes in languages other than English
* Currently incarcerated
* Fetal demise diagnosed prior to enrollment
* Known major structural chromosomal abnormalities prior to enrollment
* Participated in POPPY Pilot
Surface ECG Signal Recording for the Implantable Subcutaneous String Defibrillator (ISSD) Detection Algorithm Performance Assessment

Recorded cutaneous ECG containing arrhythmia events are separately analysed by an expert Electrophysiologist and the ISSD detection algorithm, to allow assessment of the correct detection of tachyarrhythmia events and discrimination of supra-ventricular arrhythmia of the algorithm,m compared to the expert.

cutaneous ECG electrodes positioned near the sternum and on the midaxillary line, at the approximate positions of the ISSD sense electrodes, are used to record patients undergoing Defibrillation Threshold (DFT) studies or Electrophysiology (EP) studies of different types. Two separate copies of the recordings undergo parallel and separate analysis: one is sent to an expert Electrophysiologist for determination and classification of arrhythmia events of at least 5 seconds and at least 170 beats per minute. the other is fed to the ISSD detection algorithm, with a low cutoff rate of 170 beats per minute. the results are compared to establish the accuracy of the detection algorithm and the rate of false detection / classification of arrhythmia events.

Eligibility Criteria:
Inclusion Criteria:

* candidate for ICD implantation
* candidate for an ICD DFT study
* candidate for an EP study

Exclusion Criteria:

* age \<18
Open Versus Video-Assisted Minimal-Invasive Parathyroid Surgery

The aim of the present study was to compare open minimal-invasive parathyroid surgery with video-assisted parathyroidectomy in primary hyperparathyroidism (PHPT) patients with a positive sestamibi scan in a multicentre randomized trial in order to evaluate if videoassisted surgery gave less postoperative pain and if there was a difference in operating time.

The present study is designed to compare open minimal-invasive parathyroid surgery with video-assisted parathyroidectomy in pHPT patients with a positive sestamibi scan in a multicentre prospective randomized trial.

In patients randomized to open surgery, a 15 mm transverse skin incision is made close to the site of the parathyroid adenoma indicated by sestamibi scintigraphy. In case of an enlarged upper parathyroid or dorsally located lower parathyroid, the incision is made anterior to the sternocleidomastoid muscle (SCM) whereas for anterior located lower parathyroids a central incision is chosen.

In patients randomized to a video-assisted approach, the surgeon has the option to choose either the lateral- (VAPLA) or medial (MIVAP) techniques, both initiated with a 15 mm transverse skin incision.

Postoperatively the patients receive a questionnaire for selfdocumentation.Variables recorded include postoperative pain, hypocalcaemic symptoms, breathing problems, cervical discomforts of pressure/globus and voice disturbances. A visual analogue scale (VAS) is used when appropriate. The intake of oral analgesics and calcium medication is also recorded. The questionnaire is used daily for the first four postoperative days, and thereafter weekly for four weeks.

Follow-up is done at 1 and 6 month after surgery, with measurement of plasma calcium and PTH. Continued needs of calcium or vitamin D medication, length of scar, and symptoms or signs of complications are recorded. At the six-month follow-up, patients document their opinion of the cosmetic results and the remaining neck discomfort using a VAS.

Primary outcome measures are postoperative pain and operation time. Secondary outcome measures are complications, persistent or recurrent disease, conversion rates and cosmetic results.

Eligibility Criteria:
Inclusion Criteria:

* Patients with biochemically verified primary hyperparathyroidism and with an unequivocal localisation on sestamibi scintigraphy of a solitary parathyroid adenoma

Exclusion Criteria:

* Negative or equivocal preoperative localization study, familiar HPT, previous neck surgery or neck irradiation, concomitant need of thyroid surgery, pregnancy, suspected ectopic parathyroid localization, or inability to understand information, instructions and/or comply with scheduled follow-up.
Lumbar Kinematics in People With the Low Back Pain

This study evaluates the effect of lumbar disc herniation on kinematics in the lumbopelvic region during daily living activities.

Lumbar disc herniation (LDH) is one of the causes of low back pain and contributes to increasing the socio-economic problem. Depending on the reason for the dysfunction, various classifications describing the level of advancement are used. The literature on the subject commonly uses the division into protrusion and extrusion of the intervertebral disc, as approved by the American Society of Neuroradiology.

The lumbopelvic kinematics, including gait and daily living activities, can be affected by the LDH: protrusion or extrusion. This pathology may be different due to the direction of disc migration: centre, left, right or all mentioned. Therefore, we believe that from the different direction of the disc migration the different symptoms can be observed.

Eligibility Criteria:
Inclusion Criteria:

* disc disease located in the lumbar region of the spine confirmed in the MRI
* subacute stage of the disease
* age 18-35 years

Exclusion Criteria:

* advanced degenerative-deformation changes of the spine
* previous fracture of the spine
* neurologic deficits in lower limbs or pelvis
* spondylolisthesis
* transitional vertebra
* rheumatic diseases
The Effect of Therapeutic Ultrasound on Soft Tissue: An Experimentally-induced Skin Model

The purposes of study are to investigate the effect of therapeutic ultrasound for the inflammatory skin repair and whether the tissue repair under ultrasound treament is depend on different inflammatory level.

Therapeutic ultrasound for soft tissue repair has been used in clinical during the past decades. In some recent systematic review, the evidence of clinical trials were insufficiency. We assumed the reaserch biasin clinical trials may be due to the different inflammatory level of soft tissue under the similar ultrasound intensity. Our purpose of study is to investigate the effect of therapeutic ultrasound for the inflammatory skin repair and whether the tissue repair under ultrasound treament is depend on different inflammatory level.

Eligibility Criteria:
Inclusion Criteria:

1. asia healthy subjects
2. aged 20-45 years

Exclusion Criteria:

1. disadvantaged groups
2. systemic disease, such as DM, cancer, autoimmune disorder
3. hyperhidrosis or hypothyroidism
4. a past history of dermatitis
5. active infective or inflammatory cutaneous disease
6. smoking or drinking
7. take medicine, over sun exposure, exercise or menstruation during experimental period
8. contraindication of therapeutic ultrasound
Optimization of Hip-exoskeleton Weight Attributes

The investigators are examining how weight distribution affects the way people walk, in terms of joint kinematics, kinetics, and muscle activity. The investigators are measuring these quantities while people walk while wearing a weighted belt. The investigators distribute the weights and walk for specified periods. They hypothesize that greater weight will have a greater effect on walking.

The purpose of this study is to examine how the amount and distribution of weight on the pelvis affects how people walk. The investigators two factors, weight and placement. They are examining how these factors affect muscle activation, joint motions and foot forces. The investigators plan to recruit 40 healthy adult individuals. Each of the 20 experimental conditions (3x3 factorial and one control condition with no weight) will be recorded immediately in a single session. The investigators hypothesize that weight amount, gait speed and weight distribution will all affect how people walk, which will lead towards optimized design of hip exoskeletons.

Eligibility Criteria:
Inclusion Criteria:

* Willing to commit to the full experimental session

Exclusion Criteria:

* Functionally relevant lower limb musculoskeletal injury

  * Functionally relevant osteoarthritis and weight bearing restrictions
  * Severe respiratory problems that restrict the wearer from using a metabolic rate apparatus
* Patients with cardiac issues may be included, but the cardiac issue will be noted in the health history questionnaire
Sonographic Evaluation to Predict Difficult Airway Management

the aim of this study was to evaluate the accuracy of different ultrasonographic parameters and clinical tests to predict difficult airway assessment.

Ultrasonographic parameters were: hyo-mental distence, tongue width, skin to epiglottis distence and skin to hyoid bone distence. these parameters were recorded and their predictive acurracy was studied.

the aim of this study was to evaluate the accuracy of different ultrasonographic parameters and clinical tests to predict difficult airway assessment.

Ultrasonographic parameters were: hyo-mental distence, tongue width, skin to epiglottis distence and skin to hyoid bone distence. these parameters were recorded and their predictive acurracy was studied.

This study analyzed a sample size of 200 patients undergoing elective or urgent surgery under general anesthesia and recieving neuromuscular blocking agent before laryngoscopy.

the correlation between ultrasonographic parameters and difficult laryngoscopy was studied

Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for orthopedic or viseral surgery under general anesthesia and tracheal intubation.

Exclusion Criteria:

* patients with suspected tracheal stenosis
* Patients with a poor quality ultrasonographic exam
The Effects of a Polyphenol-enriched Fruit Drink on Metabolic Health(2)

The purpose of this study is to determine whether consumption of the active product affects postprandial changes in metabolic indices, in comparison to the control product.


Eligibility Criteria:
Inclusion Criteria:

* Healthy free-living men aged from 20 to 60 years old, and postmenopausal women aged from 45 to 60 years old, on the day of inclusion
* Able to understand the information sheet and comply with all the trial procedures
* Having given written consent to take part in the study prior to participation.
* Body mass index (BMI): 18.0 - 35 kg/m².

Exclusion Criteria:

* Those diagnosed with Phenylketonuria (PKU)
* Those with known or suspected food intolerances, allergies or hypersensitivity
* Women who are known to be pregnant or who are intending to become pregnant over the course of the study
* Women who are breast feeding
* Participation in another clinical trial
* Those who have donated blood within 3 months of the screening visit and participants for whom participation in this study would result in having donated more than 1500 millilitres of blood in the previous 12 months
* Those with Full Blood Counts and Liver Function test results outside of the normal range
* Pre-menopausal women due to the potential influence of cyclical changes in reproductive hormones on insulin sensitivity
* Current smokers, or reported giving up smoking within the last 6 months
* History of substance abuse or alcoholism
* Reported history of CVD, diabetes (or fasting glucose ≥ 7.1 mmol/L), cancer, kidney, liver or bowel disease, gastrointestinal disorder or use of drug likely to alter gastrointestinal function
* Unwilling to restrict consumption of specified high polyphenol foods for 24 h before the study
* Weight loss \>3kg in preceding 2 months and body mass index \<18 or \>35 kg/m²
* Blood pressure ≥160/100 mmHg
* Total cholesterol ≥ 7.5 mmol/L; fasting triacylglycerol concentrations ≥ 5.0 mmol/L
* Medications that may interfere with the study such as alpha-glucosidase inhibitors (e.g. acarbose), insulin-sensitising drugs (e.g. metformin, thiazolidinediones), sulfonylureas, and lipid-lowering drugs. Other medications, should be reviewed by medical representative from KCL on a case by case basis.
* Nutritional supplements that may interfere with the study such as higher dose vitamins/minerals (\>200% RNI), B vitamins, Vitamin C, calcium, copper, chromium, iodine, iron, magnesium, manganese, phosphorus, potassium and zinc. Subjects already taking vitamin or minerals at a dose around 100 % or less up to 200% of the RNI, or evening primrose/algal/fish oil supplements will be asked to maintain habitual intake patterns, ensuring that they take them every day and not sporadically. They will be advised not to stop taking supplements or start taking new supplements during the course of the study.
Whole Body Vibration on Running Biomechanics

Whole body vibration (WBV) acutely improves quadriceps strength, and may improve long-term outcomes in individuals with anterior cruciate ligament reconstruction (ACLR). However, it is unclear if WBV influences athletic tasks such as running. The purpose of this study is to evaluate the influence of WBV on running biomechanics in individuals with ACLR.

Individuals with anterior cruciate ligament reconstruction (ACLR) have deficits in quadriceps muscles function that influences walking and running biomechanics. In the long term, alterations in walking and running contribute to physical disability and the development of knee osteoarthritis. Unfortunately, rehabilitation for the quadriceps muscles is often ineffective, and novel strategies to improve rehabilitation efforts are needed. Whole body vibration (WBV) acutely improves quadriceps strength, and may improve long-term outcomes in individuals with ACLR. However, it is unclear if WBV influences athletic tasks such as running.

Specific Aim 1: The purpose of this study is to determine the effect of WBV on running biomechanics in individuals with ACLR. The investigators hypothesize that WBV will improve running characteristics associated with knee osteoarthritis development.

Eligibility Criteria:
Inclusion Criteria:

* 18-35 years
* Unilateral ACL reconstruction
* At least 6 months post-reconstruction
* Recreationally active (at least 20 minutes of physical activity 3 times per week)

Exclusion Criteria:

* History of ACL graft rupture or revision surgery
* Neurological disorder
* Other lower extremity within the 6 months prior to participation
Feeding After Neonate Surgery Review

The purpose is to determine what factors, if any, lead to delayed feeding, discharge with a NG tube, G-tube placement or Nissen fundoplication.

The purpose is to determine what factors, if any, lead to delayed feeding, discharge with a NG tube, G-tube placement or Nissen fundoplication. Will review the newborn database (Lumedx as most interested in those children who have never been fed prior to their cardiac surgery. The medical charts will be reviewed at Children's Healthcare of Atlanta at Egleston Hospital. Approximately 90 charts will be reviewed for newborns undergoing surgery in the 2003 calendar year.

The factors that will be reviewed are pre-op feeding regimen, diagnosis, single vs two ventricle, open vs closed heart procedure, length of bypass, level of hypothermia, circulatory arrest, presence of TEE probe and post-op ventilation.

Eligibility Criteria:
Inclusion Criteria:

* Neonates who undergo cardiac surgery

Exclusion Criteria:

-
Study Evaluating Mylotarg (Gemtuzumab Ozogamicin) in Usual Care

This study is designed to assess the safety of Mylotarg therapy in routine practice.


Eligibility Criteria:
Inclusion Criteria:

* Treated by Mylotarg
* Provide ICF