cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Face or Chest Including 12-month Follow-up

The objective of the trial is to compare the short term efficacy of LEO 43204 gel with vehicle gel in AK on face or chest when applied topically once daily for 3 consecutive days as field treatment.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with 5 to 20 clinically typical, visible and discrete AKs within a treatment area of sun-damaged skin on either the full face or a contiguous area of approximately 250 cm2 (40 in2) on the chest
* Subjects with minimum 3 clinically typical, visible and discrete AKs within a tracking area of 50 cm2 (8 in2). The tracking area must be within the treatment area

Exclusion Criteria:

* Location of the treatment area (full face or chest) within 5 cm of an incompletely healed wound or within 5 cm of a suspected BCC or SCC
* Treatment with ingenol mebutate gel in the treatment area within the last 12 months
* Lesions in the treatment area that have: atypical clinical appearance (e.g. hyperthrophic, hyperkeratotic or cutaneous horns) and /or, recalcitrant disease (e.g. did not respond to cryotherapy on two previous occasions)
* History or evidence of skin conditions other than the trial indication that would interfere with the evaluation of the trial medication (e.g., eczema, unstable psoriasis, xeroderma pigmentosum)
Outcome Of Classic Bladder Exstrophy Repair, Assiut University Experience

1. To review surgical and medical outcomes of the previous repaired bladder exstrophy cases.
2. To present recent developments in surgical techniques and care of these patients.

* Exstrophy-epispadias complex (EEC) is a spectrum of genitourinary malformations resulting from abnormal cloacal development .
* CBE, the most common form with an incidence of 2.68 in 100,000 live births is characterized by an evaginated bladder plate, epispadias and an anterior defect of the pelvis, pelvic floor and abdominal wall
* The single most important predictor of long-term bladder growth and continence is successful primary bladder closure .
* The staged reconstruction of bladder exstrophy was proposed by Jeff and led to significant improvements in continence and renal function with excellent cosmetic results.
* The initial staged management consisted of newborn bladder and posterior urethral closure followed by bladder neck reconstruction at 2 to 3 years of age and later epispadias repair.
* The understanding that appropriately timed epispadias repair may lead to enhancement in bladder capacity led to performance of epispadias repair at 2 to 3 years of age followed by later bladder neck reconstruction. The current modification of the staged repair consists of secure bladder and posterior urethral closure in infancy followed by epispadias repair at 6 to 12 months of age and bladder neck reconstruction when the patient is able to cooperate in a good voiding program.
* Complete repair surgery is performed in a single procedure that closes the bladder and the abdomen and repairs the urethra and outer sex organs
* A failed classic bladder exstrophy (CBE) closure is defined by wound dehiscence, bladder prolapse, bladder outlet obstruction, or formation of a vesicocutaneous fistula.

Eligibility Criteria:
Inclusion Criteria:

- All patient with CBE who underwent repair at Assiut university hospital.

Exclusion Criteria:

* Cloacal exstrophy isolated epispadias previous failed repair out Assiut university hospital
ModificatiOn and Treatment of stenoseD Calcified inFrainguinal Lesions With Laser atherectomY in a Pilot Study

The MODIFY Pilot clinical study in Europe looks to evaluate acute and procedural outcomes using a new calcium atherectomy and modification solution in patients with balloon resistant calcified lesions in infrainguinal disease. The intent is to both debulk and modify the vessel to restore blood flow, improve vessel compliance and drive better outcomes. The MODIFY Pilot study will evaluate safety and performance measurements.


Eligibility Criteria:
Inclusion Criteria:

1. Patient age ≥ 18 years
2. Patient agrees to participate and comply with the protocol by signing an Ethics Committee approved consent form
3. Peripheral arterial disease with a documented Rutherford Class 2-5 and

   1. a resting ankle-brachial index (ABI) of \<0.9 or an abnormal exercise ABI (\<0.75) if resting ABI is normal. Patient with incompressible arteries (ABI \>1.2) must have a toe brachial index (TBI) \<0.7 in target limb;
   2. or a previous intervention to the target vessels with reoccurrence of symptoms
4. Balloon resistant calcific lesion apparent on angiogram by inability to dilate lesion to less than 50% diameter stenosis (DS)
5. Lesion to include fluoroscopic evidence of calcification: 1) on parallel sides of the vessel and 2) extending greater than 1 cm in length
6. De novo or restenotic lesion of the SFA, popliteal or infrapopliteal artery
7. Minimum reference vessel diameter (RVD) of 2.5mm
8. Minimum target lesion length of ≥ 5cm
9. At least one patent (\<50% stenosed) runoff vessel to the foot

Exclusion Criteria:

1. Patient is pregnant or breast feeding (Female subjects of childbearing potential must have negative serum pregnancy test 7 days prior to treatment)
2. Life expectancy \< 12 months
3. Cerebrovascular accident \< 60 days prior to procedure
4. Myocardial infarction \< 60 days prior to procedure
5. Known contraindication to aspirin, antiplatelet/anti-coagulant therapies required for procedure/follow up
6. Known allergy to contrast media that cannot adequately be pre-medicated prior to study procedure
7. Uncontrolled hypercoagulability or history of HIT or HITT syndrome
8. Serum creatinine ≥ 2.5 mg/dL tested within a week prior to procedure
9. Patient is simultaneously participating in another investigational drug or device study that will interfere with the 30 day Safety Endpoint
10. Patient is not eligible for bypass surgery or endovascular intervention
11. Planned major amputation
12. Planned or predicted cardiovascular surgical or interventional procedures prior to completion of the 30-day follow-up (including, but not limited to aortic, renal, cardiac, carotid, contralateral femoropopliteal, and contralateral below the knee
13. Lesion located within a stent or endograft
14. Ipsilateral and/or contralateral iliac (or common femoral) artery stenosis ≥ 50% DS that is not successfully treated prior to index procedure
15. Target lesion could not be crossed with the guidewire or support catheter
Removal Versus Non Removal of Ceserean Section Scar .

EXCISION of cs section skin scar and subcutaneous release versus non removal in repeated cs .aRandomized controlled trial .

All eligible participants will randimized into two groups ; gruop 1 skin removal in which we will going to remove skin scar gruop 2 skin non removal ;direct open in the middle of the previous scar Follow up will be recorded for each participant aphoto will be taken postoperative to score the healing of the wound the follow up will be at one week ,then one month ,then three month acomparison between the two groups will be done .

Eligibility Criteria:
Inclusion Criteria:

1. women with repeated ceserean section
2. pregnant women \>32 wk

Exclusion Criteria:

* DM bleeding tendency preeclampsia previous history of wound infection chronic steroid use women refused to participate in Randomized clinical trial
An Arts-Based Initiative for the Prevention of Violence Against Women and Girls

this project will evaluate a community and school based program to promote healthy relationships and prevent violence (physical, emotional and sexual dating violence) among predominately African American middle school adolescents in an urban setting (Baltimore, MD).

This initiative includes 4 major components: 1) A variety of arts based student activities related to violence prevention (during and after school theatre projects, during and/or after school visual arts project, and the web page design project. (All students will either directly participate in these activities or at least see them), 2) Curricular components for all 7th graders, 3) Violence prevention and early intervention student support/discussion groups, and 4) Faculty and staff training on the subject. The evaluation is a quasi-experimental pre/post test comparison group design (2 schools in each group), where our comparison schools convert to intervention schools one year after serving as comparison schools. We are using both group (student and teacher surveys) and school wide (climate of the school) measures pre and post intervention.

Eligibility Criteria:
Inclusion Criteria:

* Students in four middle schools in urban Baltimore, MD (Dunbar, Lombard, Calverton and Lemmel Middle Schools)

Exclusion Criteria:

-
The Effects of T4 Versus T4/T3 on Psychological Distress After Total Thyroidectomy in Thyroid Cancer Patients

The goal of this research is to compare the effects on psychological distress between T4 mono replacement group and T4/T3 combination replacement group after total thyroidectomy in thyroid cancer patients.

1. Subjects:

   * Psychologically distressed patients, such as depression, anxiety, and fatigue patient after total thyroidectomy with thyroid cancer are considered for participation. Screening of distress after total thyroidectomy is used HADS (Hospital Anxiety and Depression Scale) ≥ 8 for depression or anxiety, and MDASI-F (MD Anderson Symptom Inventory -Fatigue) ≥ 4 for fatigue.
2. Randomization:

   * Using the table of random sampling numbers, patients assign to T4 mono replacement group or T4/T3 combination replacement group.
3. Evaluation for distress:

   * Assessment will be made baseline, 4 weeks, 12 weeks and 24 weeks to investigate change of psychological distress (depression, anxiety, and fatigue). Level of distress after thyroidectomy will determine using Hospital Anxiety and Depression Scale (HADS), Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI) for depression or anxiety, and Brief Fatigue Inventory (BFI) for fatigue.


Eligibility Criteria:
Inclusion Criteria:

1. Patient who need thyroid hormone replacement therapy after total thyroidectomy for thyroid cancer
2. HADS (Hospital Anxiety and Depression Scale) ≥ 8 for depression or anxiety, or MDASI-F (MD Anderson Symptom Inventory -Fatigue) ≥ 4
3. Patient who maintain TSH recommendation range for TSH suppression according to ATA guidelines

Exclusion Criteria:

1. \< 19 or ≥ 70 years old
2. Communication difficulties or inability to complete the necessary investigations and questionnaires
3. Inability to understand purpose of the study or disagree of participation
4. Past history of psychiatric treatment or diagnosis
5. Lactation or pregnancy
6. Past medical history of other cancer diagnosis or treatment
7. Any of severe comorbid medical conditions according to ASA score ≥ 3
Association of Plasma Melatonin Levels With Delirium

Delirium is common complications in postoperative critically ill patients. However the mechanism of postoperative delirium is not well understood.The investigators designed a prospective observational study to investigate the association of perioperative plasma melatonin levels with postoperative delirium and general anesthesia. The investigators included 33 patients required intensive care more than 48 hours after sevoflurane anesthesia in an academic tertiary care hospital. The investigators measured plasma melatonin levels 4 times and assessed postoperative delirium using Confusion Assessment Method for the intensive care unit (CAM-ICU).

Delirium is common complications in postoperative critically ill patients. Although the mechanism of postoperative delirium is not well understood, there are several studies to report alternation of plasma melatonin levels after general anesthesia and suggest the link between delirium and abnormal tryptophan-serotonin-melatonin metabolism. However, there are few studies to assess the association of perioperative plasma melatonin levels with postoperative delirium and/or general anesthetics.

The investigators designed a prospective observational study to investigate the association of perioperative plasma melatonin levels with postoperative delirium and general anesthesia. The investigators included 33 patients required intensive care more than 48 hours after sevoflurane anesthesia in an academic tertiary care hospital. The investigators measured plasma melatonin levels and assessed postoperative delirium using Confusion Assessment Method for the intensive care unit (CAM-ICU). The investigators compared perioperative plasma melatonin levels between patients with and without delirium, and assessed associations of patients' demographics and anesthesia with plasma melatonin levels.

Eligibility Criteria:
Inclusion Criteria:

* patients over 20 years of age who had undergone elective surgery with sevoflurane anesthesia and were expected to require postoperative intensive care for more than 48 hours

Exclusion Criteria:

* emergency surgery, history of psychosis and drug/alcohol abuse, and vision or hearing impairment
Uncut Roux-en-Y vs Roux-en-Y

Uncut Roux-en-Y vs Roux-en-Y reconstruction after distal gastrectomy for gastric cancer

To search which is the better reconstructions by comparing and analyzing the advantages and disadvantages between Uncut Roux-en-Y and Roux-en-Y reconstructions after laparoscopy-assisted distal gastrectomy for gastric cancer.

Method: It's a prospective study including all patients underwent laparoscopy-assisted distal gastrectomy (LADG) in the First Hospital of Jilin University. All surgical procedures will be performed by the single surgery team, which is leaded by professor Wang Quan. The reconstruction method will be selected randomly from Uncut Roux-en-Y and Roux-en-Y anastomosis preoperatively without distinct indications. All clinical data, operation data, perioperative complications and related physiological indexes after surgery will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of distal gastric cancer
* underwent laparoscopy-assisted distal gastrectomy

Exclusion Criteria:

* have simultaneously other cancer
* have severe systemic inflammatory disease ,serious illness such as diabetes, chronic lung diseases
* have upper gastrointestinal surgery
* can't bear the gastric tube
* the period is too late or the tumor is too large to carry on a laparoscopy assisted radical distal gastrectomy
Visual Perturbation Training to Reduce Fall Risk in People with Parkinson's Disease

Falls during walking are common in people with Parkinson's Disease (PD). Fall risk can be attributed in part to the loss of automaticity in walking and an increased reliance on sensory cues, such as the input from the balance organ. In this project the investigators want to assess the effectiveness of rehabilitation training aiming to improve this vestibular input. The effects of a visual perturbation training in a virtual reality environment will be compared to conventional treadmill training.

Fifty participants (50-65 years) with idiopathic PD (Hoehn \& Yahr scale 2-3) will be randomly assigned to the intervention group receiving four weeks of VPT in a VR environment using the Gait Real-time Analysis Interactive Lab system (GRAIL) or a control group receiving four weeks of regular treadmill training. Primary outcome measures are spatio-temporal outcome parameters of gait and dynamic stability (gait speed, stride time/length, cadence, step-to-step variability, step width variability and trunk sway), and self-reported falls, and will be recorded at all testing phases (pre-test, after baseline, after intervention and after detraining). Secondary outcome measures will include assessments of central and peripheral vestibular function (Cervical and ocular Vestibular Evoked Myogenic Potentials) for correlation with the primary outcome measures. The secondary outcomes will be recorded at pre-testing and directly after the intervention phase.

Eligibility Criteria:
Inclusion Criteria:

* Idiopathic Parkinson's disease
* Aged between 50-65 years
* Bilateral symptoms
* Able to walk unassisted for 20 minutes (Hoehn \& Yahr stage II-III)
* Stable medication dosage (if any)
* No cognitive disablity

Exclusion Criteria:

* Non-idiopathic Parkinson's disease
* Strong variation in expressed symptoms
* Inability to walk unassisted for 20 minutes
* Underwent a medical procedure to treat Parkinson symptoms (e.g. duodopa pump, deep brain stimulator)
* Cognitive disability (score \< 21 on the Montreal Cognitive Assessment)
* Illness other than Parkinson's disease (flu, Covid-19) or disabilities that may affect gait or equilibrium
* Clogged ear(s)
* Regular fainting episodes
* Weight over 120 kg
* Participation in other clinical studies
Heart Rate Variability (HRV) in Pituitary Adenoma

Several studies have been reported that heart rate is known to be associated with prognosis in chronic diseases and acute diseases. For example, a decrease in heart rate following myocardial infarction may lead to a higher mortality rate. It is also known to predict heart failure, diabetic neuropathy, and even depression.

The combined pituitary function test artificially induces hypoglycemia to observe the secretion of pituitary hormone. The degree of change in heart rate during hypoglycemia can predict the adequacy of the test, and heart rate can be changed according to the characteristic of the tumor. Also, the prognosis can be predicted based on this.

In our study, we used a licensed device approved by KFDA (Korea Food and Drug Administration) to measure heart rate variability in patients with pituitary adenoma.


Eligibility Criteria:
Inclusion Criteria:

* Over 19 year old
* Those with Normal blood pressure range:

  90mmHg \<systolic \<140mmHg, 60mmHg \<diastolic \<100mmHg
* Voluntary participants who visited Seoul St. Mary's Hospital

Exclusion Criteria:

* Those who have been diagnosed with sleep disorders, diabetes, arrhythmia, psychiatric disorder, physical or mental breakdown, drug addicts
* Diabetes, hypertension, cardiovascular disease diagnosed by taking a drug related to the disease
* Pregnant or lactating women
* Those who drank within 12 hours before participating in the trial
* Those who are deemed inappropriate by clinical trial researchers
Assessing the System for High-Intensity Evaluation During Radiotherapy During Changes in Response to COVID-19

The primary objective of this research study is to assess Radiation Oncology healthcare providers (i.e. faculty, residents and advanced practice providers (APPs) implementation and perception of telehealth for on treatment patients in lieu of in person on treatment visits during standard of care radiotherapy during COVID-19.

A secondary aim will be to evaluate the rates of acute care during COVID-19 with telehealth in comparison to the rates during our prior Quality Improvement (QI) project (NCT04277650), considering the risk prediction based on our previously developed ML algorithm. Patient risk during this period will be assessed by the ML algorithm and actual rates of Emergency Department visits and hospitalizations (acute encounters) will be compared to the results of our prior QI project. These data will be used to discern how actual rates of acute care compare to providers' expectations both with and without telehealth implementation. Reasons for acute encounters and associated healthcare costs compared to patients undergoing standard of care assessments in NCT04277650 will be assessed to determine the percentage that are COVID-19 related. Basic demographic, disease, location of acute care, form of clinical assessments (video, in-person, telephone, etc.), and treatment information regarding the patients will also be captured following the completion of the research project for assessment.

These endpoints will establish how our current COVID-19-based precautions impact treatment-related outcomes in patient care.

Eligibility Criteria:
Inclusion Criteria:

• started outpatient radiation therapy with or without concurrent systemic therapy at Duke Cancer Center during the COVID-19 outbreak

Exclusion Criteria:

* undergoing total body radiation therapy for hematopoetic stem cell transplantation
* undergoing therapy as inpatient
* completed radiation therapy prior to algorithm execution
Action Observation Training for Functional Performance in Children with Cerebral Palsy

This study is a randomized control trial and aims to determine the effects of Action Observation on balance and mobility in patients with cerebral palsy compared to training without action observation.

Effetcs of Action observation will be assessed for functional performance which includes the parameters of balance and mobility.

Spastic CP children agd 5-12 will be recruited in the study. The participants would be assessed through Modified Ashworth scale, GMFCS, Pediatrics balance scale and GMFM-88 .

Informed Consent will ne taken after which the participants will be recruited into the two groups, where one group will recieve training with Action observation and other group will receive training without Action observation.

Baseline and Post-treatment measurements will be taken for analysis.

Eligibility Criteria:
Inclusion Criteria:

* Age 5-12.
* Spastic CP.
* Modified Ashworth Scale spasticity score 0-2
* GMFCS level I, II or III.
* Able to understand and follow commands, e.g. "Stand up, please".
* Able to sit to stand with or without assistance.

Exclusion Criteria:

* Any orthopedic procedure in the past 6 months, that could prevent exercise training.
* Any co-morbid condition such as spinal atrophy, osteogenesis imperfecta etc.
* History of chronic seizure attacks.
* Children with severe visual/hearing impairments.
* Presence of knee contractures
Dietary Reduction of AGEs to Prevent Cognitive Decline in Elderly Diabetics

Basic science and observational human studies suggest that high conentrations of circulating Advanced Glycation End-products (AGEs) may promote cognitive decline in older adults. The purpose of this pilot study is to test the methodology and feasibility of a dietary intervention to lower AGEs in elderly diabetics in order to lay the foundations for a future fully powered randomized clinical trial (RCT).To this end, the present study is focused on recruitment strategies, adherence to an innovative intervention in older adults and study methods. An exploratory aim will be the effect of the intervention on cognition and cerebral blood flow in order to obtain necessary data to estimate effect-size for a future fully-powered RCT.


Eligibility Criteria:
* Above the age 65
* T2D diagnosis
* no dementia (i.e MCI or cognitively normal )
* Not receiving cholinesterase inhibitors
* No other neurological (e.g. stroke, Parkinson's disease) or psychiatric conditions (e.g. schizophrenia, depression) that may affect cognition
* Dietary AGE levels \> 13kU
* Not participating in another clinical trial
* An informant that is willing to actively support the participant throughout the study

Exclusion Criteria:

* Dementia
* Stroke
* Other major neuropsychiatric condition that might affect cognition