cyrilzakka/clinical-trials huggingface dataset:
Fractional Microneedling RF vs Intralesional Steroid With & Without Microneedling in Hypertrophic Scars

Comparing between the effect of Fractional Microneedling Radiofrequency Versus Intralesional Steroid Injection with and without Microneedling on Tissue levels of PDGF \& CTGF in Hypertrophic Scars

In each patient, each one of the two scars, or each side of a large scar will be assigned to one of the following treatment methods: 1-Fractional microneedling radiofrequency 2-Intralesional steroids injection. Scars treated with intralesional steroids will be subgrouped into two groups, one group treated with only intralesional steroids and the other group treated with intralesional steroids and followed by microneedling. Fractional microneedling radiofrequency parameters; Power: 6 v, Exposure time: 800 ms. Depth: 2.5 mm (using non-insulated micro-needles), Frequency: 2 Hz. For intralesional steroids injection, Triamcinolone acetonide will be injected in concentration 1:2 (20 mg/dl) using insulin syringe. Microneedling will be done using the same tip of the fractional microneedling radiofrequency at same depth. All patients will receive 5 treatment sessions 4 weeks apart.

Eligibility Criteria:
Inclusion Criteria:

* Patients with mature hypertrophic scars.
* Patients with age above 18 years.
* Both males and females.
* Patients with two separate lesions, each 3 cm length at least OR a large sized lesion 10 cm length at least.

Exclusion Criteria:

* Patients with unrealistic expectations.
* Patients with active skin infections or autoimmune diseases.
* Non-compliant patients.
* Patients who had received any form of treatment for scars during the last six months.
* Recent use of isotretinoin within six months prior to the procedures.
* Patient with known allergy to lidocaine.
* Pregnancy \& Lactation.
Accuracy of Dilution of EUS-FNA Pancreatic Cyst Fluid for Carcinoembryonic Antigen (CEA) Measurement

The purpose of this research project is to determine if pancreatic cyst fluid can be diluted and provide an accurate Carcinoembryonic Antigen (CEA) level. The investigators hypothesis is that pancreatic cyst fluid obtained by EUS-FNA can be diluted effectively and accurately for the measurement of CEA levels.

Potential subjects will be identified based on the indication of a pancreatic cyst requiring EUS-FNA. The procedure will be performed as usual per standard protocol with EUS-FNA of the cyst. Once the fluid is aspirated, it will be measured and if the fluid volume is 2.25 mL or greater than the patient will be included in the study.

A micropipette will be used to ensure exact volumes are measured. The first 1 mL of cystic fluid will be sent to the lab for regular CEA analysis, per standard protocol. The remaining fluid, which would usually be discarded, will then be used for the study. The micropipette will be used to mix 0.75 mL of cyst fluid with 0.25 mL of normal saline (designated sample #2). Next, 0.5 mL of cyst fluid will be mixed with 0.5 mL of normal saline for the next study sample (designated sample #3). These two study samples will be sent to the lab separately using de-identified information, and these values will not be part of the patient's medical record and will not affect clinical management or decision-making. The study samples will be given a unique identifier that will not have any patient identification. The unique identifier will allow the study researchers to link the values to the correct patient by using a password protected program that cannot be accessed by the public.

This study will not require any additional patient participation, and will not impact the length of the procedure. The only additional time will be from the study researchers and the EUS technologists diluting the samples, which will not affect the procedure time itself. If a single patient has more than one cyst, each cyst can be included in the study separately. No additional photographs, videos or data other than the standard data for the procedure will be produced.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for EUS-FNA of a pancreatic cyst
* Cyst must yield 2.25ml (or greater) of fluid

Exclusion Criteria:

* Cysts yielding less than 2.25ml of fluid
F-18-PSMA-1007 Versus F-18-Fluorocholine PET in Patients With Biochemical Recurrence

This study evaluates the diagnostic performance and safety of F-18-PSMA-1007 and F-18-Fluorocholine PET/CT imaging in patients with suspected recurrence of prostate cancer after previous definitive treatment.


Eligibility Criteria:
Inclusion Criteria:

* male with original diagnosis of prostate carcinoma with prior definitive therapy
* suspicion of recurrence (3 consecutive PSA rises and/or PSA rise by 2.0 ng/mL or more above nadir after radiotherapy or cryotherapy and/or PSA rise by greater than 0.2 ng/mL after prostatectomy)
* life expectancy of 6 months or more as judged by the investigator
* willing and able to undergo all study procedures
* informed consent in writing (dated and signed)

Exclusion Criteria:

* age: less than18 years
* contraindications for F-18-Fluorocholine
* contraindications for any of the ingredients of F-18-PSMA-1007
* close affiliation with the investigational site; e.g. first-degree relative of the investigator
* at the time of enrolment into this study, participating in another therapeutic clinical trial or has completed study participation in another therapeutic clinical trial within 5 days of enrolment into this trial
* having been previously enrolled in this clinical trial
* mental conditions rendering the subject incapable to understand the nature, scope, and consequences of the trial
* being clinically unstable or requiring emergency treatment
* being considered a vulnerable person
Efficacy and Safety of Arbaclofen Placarbil in Subjects With Spasticity Due to Multiple Sclerosis

To evaluate the efficacy of three doses of XP19986 (arbaclofen placarbil) compared to placebo for the treatment of spasticity in subjects with multiple sclerosis (MS).


Eligibility Criteria:
Inclusion Criteria:

1. Has multiple sclerosis (MS) based on Poser or McDonald Criteria (all subtypes of MS will be accepted, including relapsing remitting, primary or secondary progressive, if disease is stable per exclusion criteria).
2. Maximum Ashworth Score Scale score of ≥ 2 in at least one of the following muscle groups on either side of the body: hip abductors/adductors, knee flexors/extensors, ankle flexors/extensors.
3. Expanded Disability Status Scale (EDSS) rating between 3.0-8.0 inclusive.
4. If a subject is on disease modifying MS treatment, the dosage, frequency, and route of administration must be stable for at least 30 days before screening and is expected to be stable throughout the study.
5. Spasticity Disability Rating of 2 or higher at Baseline.
6. Willing to discontinue and refrain from using for the duration of the study drugs for the treatment of spasticity or likely to affect spasticity (including, but not limited to, baclofen, tizanidine, diazepam, clonazepam, metaxalone, dantrolene, cyclobenzaprine, carisoprodol, clonidine, vigabatrin, valproic acid and cannabis).

Exclusion Criteria:

1. Spasticity due to neurological disorder other than MS or other conditions that may confound the assessment of spasticity.
2. Subject has clinically evident muscle contractures resulting in irreversible spasticity in lower extremities.
3. Subjects who have suffered an acute relapse of MS (as determined by the Investigator) within 90 days prior to Screening, or have had more than 1 relapse within the year prior to Screening
4. Botulinum toxin injection within 6 months of Screening or has current residual associated side effects at Screening.
5. Subjects receiving concomitant medication from more than one of the following three drug classes: (Antiepileptic drugs, Tricyclic anti-depressants and Opioids)
6. Subjects on the following medications, at doses above the specified limits, are excluded if they cannot maintain a level within these limits

   * Gabapentin ≤ 1800 mg per day or pregabalin ≤ 150 mg per day
   * Amitriptyline ≤ 75 mg per day or nortriptyline ≤ 75 mg per day
   * Opioids ≤ 30 mg morphine equivalents per day.
7. Evidence of unstable or severe systemic illness, including but not limited to: Cardiovascular disease (e.g., chronic ventricular arrhythmia, unstable angina or CHF), respiratory disease (e.g., sleep apnea, COPD requiring oxygen therapy or hospitalization in last year), endocrine disease, hepatic disease (e.g., chronic active hepatitis), renal disease, or immunodeficiency.
Comparison of the Cosmetic Effects of Bakuchiol and Retinol

Subjects will be assigned to a retinoid cream or bakuchiol to compare the cosmetic effects. This will take place over a 12 week period.

Bakuchiol is a phytochemical that has demonstrated cutaneous antiageing effects when applied topically. Early studies have suggested that bakuchiol is a functional analogue of topical retinoids, as both compounds have been shown to induce similar gene expression in the skin and lead to improvement of cutaneous photodamage. No in vivo studies have compared the two compounds for efficacy and side-effects.

The aim of this study is to compare the cosmetic effects of Bakuchiol to Retinol over a 12-week period.

Eligibility Criteria:
Inclusion Criteria:

• Individuals aged 30-55

Exclusion Criteria:

* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant or breast feeding women
* Prisoners
* Those with acne, eczema, seborrheic dermatitis, rosacea or polycystic ovarian syndrome
* Those who have used isotretinoin in the last 6 months
* Those who have used products containing salicylic acid, beta hydroxyl acids or vitamins A, C, or E in the last 14 days
* Those who have used topical antibiotics or topical retinoids in the last 30 days
* Those who are currently smoking or have smoked within the past 3 years.
* Those who have had a recent surgical or cosmetic procedure in the last 3 months that can affect facial wrinkles or facial hyperpigmentation, such as botulinum toxin injections, chemical peels, laser based therapies to the face, or face lift surgeries
Oropharyngeal Dysphagia in Patients With Community Acquired Pneumonia

This study investigates relationship between community acquired pneumonia and oropharyngeal dysphagia in patients admitted to a department of respiratory medicine in Northern Denmark.

The endpoints will be re-hospitalisation and mortality.

Community acquired pneumonia (CAP) is an important cause of morbidity and mortality in elderly patients. Risk factors are many including oropharyngeal dysphagia (OD). Systematic screening of OD is recommended for at-risk popolations, however these resommandations do not specifically address elderly patients hospitalized with CAP.

In this study OD is assessed in all patients by Volume-Viscosity Swallowing Test (V-VST) The study is registered by the Danish Data Protection Authority (2008-58-0028)

Eligibility Criteria:
Inclusion Criteria:

* Temperature \> 38 degrees Celcius
* New infiltrate on chest x-ray
* Increased C-reactive protein (CRP)
* Either cough, dyspnea, pleuritic chest pain, expectoration, or tachypnea

Exclusion Criteria:

* patients referred from the intensive care unit
* reduced cognitive awareness if not able to able to cooperate with the assessment of oropharyngeal dysphagia
Effects of Oral Contraceptives on DNIC in Non-painful Healthy Women

The purpose of this study is tu assess the influence of oral contraceptives (OC) on diffuse noxious inhibitory control (DNIC) in healthy women, tested during high, low endogenous estrogens sessions and ovulatory period.

After being informed about the study and it protocol, all patients giving written informed consent, will undergo to a cephalic (masseter) and extracephalic (finger) mechanical stimulus to evaluate the threshold of mechanical pain, and physiological records of systolic/diastolic pressure and heart rates. After, we will evaluate the threshold response and physiological rates to the same mechanical stimulus under a thermal (cold) conditional pain (TCP) at 3 different moments of menstrual period in No contraceptive group (No OC) versus Contraceptive group (CO). Finally, we will compare the mechanical threshold response, physiological rates and pain perception between both groups.

Eligibility Criteria:
Inclusion Criteria:

* Healthy women with oral contraceptive treatment (for at least 3 consecutive months), greater than or equal to 15 years old.
* Healthy women without oral contraceptive treatment, greater than or equal to 15 years old.
* Non pregnant women.
* Not under convulsive, chronic pain, antidepresive, antihypertensive, pharmacological treatments
* Without systemic pathologies.

Exclusion Criteria:

* Treatment of a pain, depression, hypertension, convulsion condition with or without medication.
* Regular use of benzodiazepines.
* Systemic pathologies
* Pregnant women
* Menopausal women
The Effect of Motivational Messages on Optimism, Hopelessness and Life Satisfaction

The Covid-19 pandemic has affected global health systems and required healthcare professionals to show high performance. In this process, the mental health of intensive care nurses, who undertake the biggest burden in health systems, is negatively affected by the high working hours and patient care burden during the pandemic. When the literature is reviewed, pessimistic thinking, feeling hopeless and not enjoying life at more exacerbated levels can be observed in intensive care nurses. It is concluded that studies are needed to increase the motivation of intensive care nurses during the Covid-19 pandemic.In this study, it was aimed to evaluate the effect of motivational messages on optimism, hopelessness and life satisfaction of intensive care nurses during the Covid-19 pandemic.


Eligibility Criteria:
Inclusion Criteria:

* agreeing to participate in the study
* being a nurse
* working in intensive care during the COVID-19 pandemic

Exclusion Criteria:

* underfilling or not fill out forms and scales
Mood Management Phone Counseling in Smoking Cessation

Information obtained from this study will help us to have a better idea of how phone counseling may facilitate the process of quitting smoking for individuals with a history of recurrent depression.

Adult smokers with a history of recurrent major depression (MDD) report higher levels of depressive symptoms when presenting for smoking cessation treatment and have poor smoking outcomes relative to other smokers. Carefully conducted clinical trials have supported the efficacy of cognitive-behavioral mood management treatment for depression in improving smoking cessation outcomes in this high-risk group. Although efficacious, these intensive group treatments require significant resources and thus may have limited impact outside of specialized smoking cessation programs. In the present study we will develop and obtain preliminary data on the efficacy of proactive telephone counseling for smoking cessation that integrates cognitive-behavioral mood management skills training for depression (MM). Smokers with a history of recurrent MDD will be randomly assigned to the proactive telephone counseling for smoking cessation with mood management (MM) or a standard proactive telephone counseling (ST) comparison condition. We expect that this program of research will result in the development of a specialized, efficacious treatment with broad reach into a significant subpopulation of smokers at greatest risk for difficulties quitting, and will therefore have important clinical and public health significance in decreasing the overall prevalence of cigarette smoking.

Eligibility Criteria:
Inclusion Criteria:

* history of two or more past episodes of depression
* regular cigarette smoker for at least one year
* currently smoking 10 or more cigarettes each day
* want to quit smoking

Exclusion Criteria:

* Current Depressive Episode
* Current Alcohol of Substance abuse
* Pregnant, planning to become pregnant
Mannitol Improves Cerebral Oxygen Saturation

Decreased cerebral oxygen saturation (rSO2) was reported to occur during insufflation for laparoscopic procedures due to increased Intracranial pressure (ICP) with resultant decrease in cerebral perfusion pressure.

Forty patients scheduled for laparoscopic cholecystectomy will be enrolled in this double blind, randomized controlled study. Patients will receive either 0.5g/kg of 20% intravenous (i.v.) mannitol infusion over 10 minutes immediately before induction of anesthesia (group M) or an equal volume of 0.9% normal saline instead (group C). Primary outcome measure is rSO2. Secondary outcome variables include extubation time, clinical assessment of consciousness recovery using the modified Observer's assessment of alertness/sedation scale (OAA/S) and the mini-mental state examination (MMSE) for cognitive evaluation after recovery.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical status I or II
* aged between 25 and 50 years
* with a body mass index (BMI) 22-34 kg/m2

Exclusion Criteria:

* obstructive or restrictive pulmonary disease
* cardiac dysfunction
Study of Transdermal Fentanyl Patch to Treat Postoperative Pain in Total Knee Arthroplasty

The purpose of this study is to determine whether transdermal fentanyl patch

Total knee arthroplasty (TKA) has severe postoperative pain that prevents mobilization of patient. The best standard analgesia regimen is patient-control analgesia (PCA) which requires a PCA pump that is expensive.

Transdermal fentanyl patch (TFP)(50 mcg/hr) can release fentanyl into blood circulation at rate 50 mcg/hr for three days. It has slow onset of about 12-14 hours, so it's used to treat chronic pain, not popular for a cure of pain. If the investigators apply TFP at appropriate times, i.e. 12-14 hours before surgery, it may be used to treat acute postoperative pain.

If it can give good analgesia for TKA, it can replace PCA. The benefit is that it is much cheaper and more convenient.

Eligibility Criteria:
Inclusion Criteria:

* Patients who were scheduled for TKA gave informed consent for inclusion

Exclusion Criteria:

* ASA class 3-4
* Known allergy to any of the drugs to be used, eg. TFPs ,MO
* History of substance or alcohol abuse, and tolerance or dependence on opioids
* Can not use PCA
* Contraindication for spinal anesthesia
Post Operative Pain Control of POEM Procedure

Peroral endoscopic myotomy (POEM) is a minimally invasive treatment for esophageal achalasia with a natural orifice transluminal endoscopic procedure and far less invasive than the standard surgical or laparoscopic Heller myotomy (LHM). Less is known about the postoperative pain after POEM and the minor surgery trauma, short length of stay may lead to underestimation of postoperative pain control. We tend to observe the pain status after the POEM surgery under the empirical treatment in our center, and find a proper intra-operative way of pain control to solve the post-operative pain and seek the possible influence factors of postoperative pain.


Eligibility Criteria:
Inclusion Criteria:

* Achalasia patients undergoing elective POEM surgery
* age 18-80
* BMI 18-30 kg/m2

Exclusion Criteria:

* Patient refusal
* ASA≥ 3
* abnormality of liver and kidney function in patients
* patients with mental disorder, language disorder, and other patients who can not cooperate with and complete the follow-up and questionnaire pre- and post- operatively
* patients (including propanotamo, propofol, lidocaine, and other drugs) against drug taboos in the anesthetic scheme
* patients with chronic pain before operation with analgesic drugs
Remote Monitoring and Virtual Collaborative Care For Hypertension Control To Prevent Cognitive Decline

This purpose of this study is to examine an aggressive method of blood pressure control that involves home blood pressure monitoring and management of medications by a team of clinical pharmacists in coordination with a primary care physician.


Eligibility Criteria:
Inclusion Criteria:

* Age 65 and older
* Active patient in participating primary care clinic
* Access to compatible "smartphone" or device (i.e., Android, Kindle or Apple with internet connectivity)
* Elevated blood pressure as defined by:

Systolic Blood Pressure \>140 at current visit AND documented history of hypertension OR Systolic Blood Pressure \> 140 at current visit and at another visit in last 18 months OR Systolic Blood Pressure \>160 at current visit

* Sufficiently fluent in English to participate in study procedures
* Adequate vision and hearing to complete study procedures

Exclusion Criteria:

* Clinically significant illness that may affect safety or completion per their treating Primary Care Physician or study physician
* End stage renal disease on dialysis
* Chronic active disease with expected life expectancy \< 2 years as determined by the study team
National, Multicenter, Retrospective, Prospective Study to Evaluate Pediatric Gastrointestinal Eosinophilic Disorders

Eosinophilic gastrointestinal disorders (EGIDs) are a heterogeneous group of emerging chronic inflammatory diseases that may affect different gastrointestinal (GI) tracts. Based on the anatomical site involved, EGIDs are distinguished into eosinophilic esophagitis (EoE) and non-esophageal forms, which are subdivided into eosinophilic gastritis (EoG), gastroenteritis (EoGE), and colitis (EoC). EoE is considered the prototype of EGIDs. Since the first description of a case series of patients with EoE, fundamental scientific advances have been achieved, culminating in the redaction of international diagnostic and therapeutic guidelines. In contrast to EoE, non-esophageal forms of EGIDs are still a clinical enigma with evidence limited to a few retrospective studies. In the last decade, an increase in the prevalence of EGIDs has been observed in the pediatric age. Unfortunately, the epidemiology of EGIDs in Italy is still inconsistent and clear estimates are not available.

Firstly, this study will allow us to assess and clarify several clinical and epidemiological aspects of pediatric EGIDs, in particular:

1. prevalence and incidence of pediatric EGIDs in Italy,
2. the clinical features and potential phenotypes of pediatric EGIDs with potential impact on therapy and management,
3. diagnostic work-up and adherence to the EoE international guidelines to improve the management, quality of care, and quality of life of affected patients.

This study has no ethical problems since EoE patients are treated according to international guidelines and those with non-esophageal EGIDs according to the latest scientific evidence.


Eligibility Criteria:
Inclusion Criteria:

- All EGIDs patients aged 0-18 years and followed at the centers involved in the study will be considered eligible. Informed consent must be obtained from each enrolled patient and signed by a parent/legal guardian and patient (when older than six years).

Exclusion Criteria:

- This study will not include patients with:

1. a diagnosis of EGIDs made more than five years before the study participation;
2. a diagnosis of EoE not in line with current international guidelines;
3. a secondary cause of intestinal eosinophilic inflammation (inflammatory bowel diseases, autoimmune diseases, vasculitis, graft versus host disease, malignancies).