cyrilzakka/clinical-trials huggingface dataset:
Klotho in Chronic Kidney Disease-associated Pruritis (CKD-aP)

Studying whether Klotho and FGF23 have a role in UP and whether their expression change by BB-UVB with the improvement of pruritus.

Uremic pruritus (UP), also known as Chronic Kidney Disease-associated pruritus (CKD-aP), is the most common cause of Generalized Pruritus (GP). UP is multifactorial; not due to a single cause but as a result of combined action of multiple factors. UP has a major clinical impact because it is strongly associated with poor quality of life, impaired sleep, depression, and increased mortality. UP patient always feels he is drained and distressed.

Alpha Klotho is the protein product of the anti-aging klotho gene. This protein exists in two forms: soluble Klotho (s-Klotho) and membranous Klotho (m-Klotho). The kidney is the principal organ that produces, regulates, and metabolizes Klotho.

Membranous Klotho acts as a co-receptor to enhance the binding of fibroblast growth factor 23 (FGF23) to FGF receptors (FGFRs) through the formation of Klotho/FGFR/FGF23 complex. Interestingly, soluble Klotho can also bind to FGF23/FGFR, but it prevents high FGF23-induced toxicity.

In chronic kidney disease( CKD), soluble Klotho is still detectable although it is much lower than in healthy human beings, suggesting that it is produced from extrarenal organ(s) or tissue(s) not yet identified which may be the skin.

FGF23 is a peptide released from bone tissue osteocytes and osteoblasts. It plays an important role in the bone-kidney axis and the regulation of calcium and phosphate homeostasis. In CKD, Klotho is linearly decreased prior to the rise of FGF23 so it is considered a biomarker for early detection of kidney damage.

Klotho deficiency contributes to vascular and soft-tissue calcification in CKD patients. In CKD-aP patients, there is metastatic micro-calcification due to calcium deposition in skin and this is one of the etiological causes of UP. Whether Klotho has a role in this assumption is still unclear.

Phototherapy is a proven method for the management of many pruritic disorders. Narrowband ultraviolet B (NB-UVB) can be considered as a feasible treatment option for CKD-aP. One of its possible mechanisms is the reduction of skin calcium-ion content. Whether this is via changing Klotho expression is still unknown.

Therefore, our study aims at knowing whether Klotho and FGF23 have a role in UP and whether their expression change by NB-UVB with the improvement of pruritus.

Eligibility Criteria:
Inclusion Criteria:

* Patients with CKD on dialysis.
* Age \>18 years old.
* Both sexes.

Exclusion Criteria:

* Age \<18 years old.
* Any contraindication to phototherapy (e.g, past skin cancer) for those with pruritus.
Comparison of Analgesic Efficacy of PENB Block with FICB in Post Operative Hip Fracture Patients

This study was done to evaluate two different interventions for postoperative pain control in patients undergoing hip surgeries. Fifty patients, divided in two equal groups, were included in the study. Patients in Group P were given pericapsular nerve group (PENG) block while those in Group F were given fascia iliaca compartment block (FICB). Pain score, using Numeric Rating scale as a measurement tool, was assessed at one, six, eighteen and twenty fours after the procedure as a primary outcome. Total tramadol consumption in milligrams was recorded as a secondary outcome.


Eligibility Criteria:
Inclusion Criteria:

* surgical correction of fracture neck of femur under spinal anaesthesia

Exclusion Criteria:

* allergy to local anaesthetics
* bleeding disorders
* morbid obesity with BMI more than 35
* patients of chronic pain
* drug addiction
* psychiatric issues
The Study of Intradialytic Symptoms in Subjects Treated With Qd 500vs Qd 300

Study Goal is to determine the impact of dialysate flow rate (Qd) on Subject reported dialysis related symptoms and on time to recovery post dialysis.

The objective of this study is to determine if Subjects who report dialysis symptoms while meeting adequacy (as determined by Kt/V of 1.2 or greater) on thrice weekly dialysis or who have a recovery time of at least 4 hours when treated on a conventional, i.e. non Tablo, hemodialysis device feel better with a reduced dialysate flow rate of 300ml/min based on an assessment of time to recovery post dialysis and Subject reported symptoms via a modified weekly ESAS survey.

Eligibility Criteria:
Inclusion Criteria:

1. Subject has provided informed consent and has signed a Health Insurance Portability and Accountability Act of 1996 (HIPAA) compliant authorization statement.
2. Subject is at least 18 of age.
3. Subject has end stage renal disease (ESRD) adequately treated with thrice weekly dialysis.
4. Subject is currently stable on dialysis for at least 3 months on a conventional dialysis machine and Qd of 500ml/min or higher with no change in the following dialysis prescription parameters over that time: Qb, Qd, Dialyzer, Time.
5. Subject has a baseline Kt/V of greater than 1.2.
6. Subject has a stable vascular access.
7. Subject reports time to recovery of more than 4 hours or a modified ESAS with at least 5 symptoms of which at least 2 are rated as moderate (rating of 4-6) or severe (rating of 7-10).

Exclusion Criteria:

- 1. Subject is unable to complete the questionnaires. 2. Subject is pregnant or planning to become pregnant. 3. Subject is scheduled for a change in modality or expected kidney transplant in the next 3 months.

4. Any other documented condition that the Investigator feels would prevent the Subject from successful inclusion in the study.
A Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension -AYAME Study-

The purposes of this study are to determine the optimal concentration of DE-117 ophthalmic solution compared to the placebo ophthalmic solution and to determine if intraocular pressure reduction after 4 weeks of treatment with DE-117 ophthalmic solution is non-inferior to latanoprost ophthalmic solution 0.005%.


Eligibility Criteria:
Inclusion Criteria:

* Primary open angle glaucoma or ocular hypertension

Exclusion Criteria:

* Patients at risk of progression of visual field loss
* Patients with severe visual field defect
* Patients with any diseases that preclude participation in this study for safety reasons
The Objective of This Study is to Evaluate the Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD) Who Have Had an Inadequate Response to Antidepressants Alone

The objective of this study is to evaluate the efficacy, safety and tolerability of cariprazine as an adjunctive treatment to antidepressant therapy (ADT) in patients with MDD who have had an inadequate response to antidepressants alone.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent has been obtained.
* Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable (eg, Written Authorization for Use and Release of Health and Research Study Information \[US sites\] and written Data Protection consent \[EU sites\]).
* Participant must be an outpatient at the time of Visit 1 (Screening).
* Participant meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for MDD based on Structured Clinical Interview for DSM-5 (SCID-5), with a current major depressive episode of at least 8 weeks and not exceeding 24 months in duration at Visit 1/Screening. A diagnosis of MDD with psychotic features will be acceptable.
* Diagnosis of MDD confirmed through a formal adjudication process.
* Participant demonstrates ability to follow study instructions and likely to complete all required visits.
* Participant must have an inadequate response, as measured by the modified antidepressant treatment response questionnaire (ATRQ), to 1 to 3 antidepressants administered during the current episode at an adequate dose (as per package insert) and for at least 6 weeks duration, with at least one dose escalation during the current depressive episode.
* Only one antidepressant (of sufficient dose per package insert and taken for at least 6 weeks) will be allowed at randomization and Participants must agree to continue taking the same ADT dosing regimen through completion of Visit 6/early termination (ET). Participants who are taking more than one antidepressant at Screening, regardless of the indication, will need to discontinue all other antidepressants prior to Visit 2 (Baseline).
* Male and female Participants must agree to use a medically acceptable and highly effective method of birth control during the course of the entire study.
* Women of childbearing potential (only) must have a negative serum β-human chorionic gonadotropin pregnancy test prior to Visit 2.

Exclusion Criteria:

* Diagnosis of any current psychiatric diagnosis other than MDD (including those with current intellectual development disability) with the exception of specific phobias.
* Participant has a history of intolerance or hypersensitivity to cariprazine or other drugs of the same class or to rescue medications.
Nexium Capsules Clinical Experience Investigation

The purpose of this study is to confirm the safety profile / factors which impact safety and efficacy of Nexium capsules in daily clinical usage for the patients who have been prescribed Nexium for "gastric ulcer", "duodenal ulcer", "anastomotic ulcer", "reflux oesophagitis", "non-erosive reflux disease", or "Zollinger-Ellison syndrome"

Nexium capsules Clinical Experience Investigation

Eligibility Criteria:
Inclusion Criteria: - Patients treated with Nexium for the first time due to gastric ulcer, duodenal ulcer, anastomotic ulcer, reflux oesophagitis, non-erosive reflux disease, Zollinger-Ellison syndrome. Exclusion Criteria: - None
Evaluation of Childhood Blood Pressure and Lipid Screening

To help clarify the validity, reliability, and utility of blood pressure (BP) and lipid screening in childhood.

BACKGROUND:

To be useful, a screening program depends on an acceptable, valid, and reliable test, and an efficacious and cost-effective intervention in the population of interest. Screening children to detect those at high risk of adult hypertension or hypercholesterolemia was examined from this viewpoint. Long-term studies starting in childhood have so far revealed less than optimal validity of blood pressure and serum cholesterol levels in childhood as predictors of adult levels. However, information was sparse regarding reliability of measurements, accounting for which could improve validity. The efficacy of interventions that could be widely applied in childhood had not yet been demonstrated. In addition, the costs of an extensive screening program and risks such as misclassification, side effects, and labeling needed to be evaluated. The results of this study helped determine whether screening for risk factors in childhood was a useful method for preventing cardiovascular disease in adults.

DESIGN NARRATIVE:

The study examined the following factors that were key elements in the evaluation of screening: 1) within-person variability of BP and lipid measurements (i.e., the reliability of the test) and its impact on tracking of BP and lipids from childhood to adulthood, 2) calculation of predictive values, sensitivity, and specificity of childhood BP and lipid measurements considered as screening tests for adult values, after correcting for within-person variability (i.e., validity), 3) one potentially effective intervention for BP control in children, that is, calcium supplementation, and 4) evaluating the cost-effectiveness of screening to identify children at high risk of developing adult hypertension or hyperlipidemia.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) recor

Eligibility Criteria:
No eligibility criteria
Regional Blocks for Postoperative Analgesia After Video-Assisted Thoracoscopic Surgery

The aim of this study is to compare serratus anterior plane block and erector spinae plane block for postoperative analgesia after VATS as measured by the duration till 1st requirement of analgesia.

Video-assisted thoracoscopic surgery has become the standard surgical procedure for both minor and major oncological lung surgery, as it is considered less invasive and equally effective compared with thoracotomy . However, it is a fact that pain following VATS can be severe and long-lasting. According to Homma et al., 18.8% of patients who undergo VATS present with persistent pain 2 months after surgery.

Serratus anterior plane block is a type of interfascial plane block that was defined by Blanco and his colleagues in 2013 .Ultrasound-guided SAPB has recently gained the interest of the anesthesiologists and pain physicians due to its efficacy, relative ease, single-injection method with limited side-effect profile.

The SAPB targets the lateral cutaneous branches of the thoracic intercostal nerves, which arise from the anterior rami of the thoracic spinal nerves and run in a neurovascular bundle immediately inferior to each rib. At the midaxillary line, the lateral cutaneous branches of the thoracic intercostal nerve traverse through the internal intercostal, external intercostal, and serratus anterior muscles innervating the musculature of the lateral thorax.These branches of the intercostal nerves, therefore, travel through the two potential spaces described above. Local anesthetic inserted into these planes will spread throughout the lateral chest wall, resulting in paresthesia of the T2 through T9 dermatomes of the anterolateral thorax.

Erector spinae plane block is an interfascial plane block that was defined by Forero and colleagues in 2016. Erector spinae plane block has a wide indication range for pain management of the thoracic, abdominal , lumbar, hip, and even shoulder areas . Erector spinae plane block is a paraspinal block that targets the dorsal and ventral rami so that it can provide analgesia in the anterolateral and posterior chest wall .

Erector spinae plane block emerged in recent years to be effective in reducing postoperative pain at 24 h, i.e. preoperative ESPB plus intravenous opioid reduced pain scores and opioid consumption after VATS when compared with intravenous fentanyl only .

Eligibility Criteria:
Inclusion criteria

* Patients with American Society of Anesthesiologists (ASA) physical status 1-3 --
* scheduled for VATS .

Exclusion Criteria:

1. ≤20 or ≥80 years old.
2. Refusing to participate in the study .
3. History of allergy to the medications used in the study.
4. Contraindication to regional anesthesia (including coagulopathy and local infection).
5. Severe hepatic impairement (serum protein \< 3g/dl and serum bilirubin \> 3mg/dl) .
6. Renal dysfunction (as determined by creatinine levels greater than 2mg/dl or predicted creatinine clearance (CLcr)\<50ml/min).
7. Psychiatric disorder.
8. Pregnancy.
9. Body mass index (BMI) ≥40 or ≤18 kg/m2.
Mnaual Therapy in Treatment of Carpal Tunnel Syndrome

2 groups of patients randomized for the treatment.

One group treated with neurodynamic techniques and the the other with the desensitization maneuvers.

Eligibility Criteria:
Inclusion Criteria:

* Pain and paresthesia at median nerve distribution ,positive tinel sign and positive phalen sign.

Exclusion Criteria:

* Any sensory and/or motor deficit in either ulnar or radial nerve
* age greater than 55 years .
* male sex.
Xylitol Chewing-gums: Concentration in Saliva and Antibacterial Effect

a double-blind cross-over in vivo study was performed to measure the salivary concentration of Xylitol released from the two chewing gums containing different amount of the polyol. The study had a cross-over design: the first half of the sample used the chewing-gum with Xylitol as the only sweeteners (64.5% of chewing-gum weight) and the other half use the chewing-gum with Xylitol among the sweeteners (22% of chewing-gum weight), after a 7-days wash-out period, the two sub-groups inverted the chewing gums. Subjects were instructed to consume the products as they normally would be consumed.

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Eligibility Criteria:
Inclusion Criteria:

* good general health,
* the absence of diseases that can alter the saliva secretion rate
* a stimulated saliva flow at least of 1 ml/min.

Exclusion Criteria:

-
Do Patients With Skin Psoriasis Have Sub-clinical Features of Active Psoriatic Arthritis on Musculoskeletal UltraSound?

Psoriatic Arthritis is an inflammatory condition that typically affects joints and soft tissues such as tendons. Poorly controlled or untreated psoriatic arthritis can lead to joint damage, disability and poor physical and mental wellbeing. Evidence suggests that early diagnosis and treatment of psoriatic arthritis can minimise adverse health outcomes.

Musculoskeletal ultrasound has become an extremely useful tool in aiding rheumatologists to diagnose inflammatory joint conditions particularly at an early stage in the course of a disease.

Psoriatic arthritis is known to affect up to 30% of patients with skin psoriasis. Therefore, national dermatology guidelines advise that patients with skin psoriasis should be asked about any joint symptoms at least every year.

This study investigates whether skin psoriasis patients who are not on biologic treatment are indeed being asked about any joint symptoms and we subsequently invite patients for a musculoskeletal ultrasound scan to see if they have features of early psoriatic arthritis on ultrasound. Those who do are then invited for a thorough rheumatology clinical assessment.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Psoriasis by a dermatologist
* Aged 18 or more
* Reasonable fluency of spoken English

Exclusion Criteria:

* Existing diagnosis of Psoriatic arthritis
* Currently on biologics for treatment of their skin Psoriasis (as this would potentially treat and thereby diminish joint symptoms associated with PsA)
* Aged \<18years old (the study focusses on an adult population)
* Currently in prison (would be unable to attend the study ultrasound scan)
* Unable to give written consent for a musculoskeletal ultrasound e.g. advanced dementia, learning difficulties (may be unable to appreciate the reason for the study and may be unable to tolerate sitting relatively still for an ultrasound scan for 60 minutes)
A 20-Week Study of a New Treatment for Men With Benign Prostatic Hyperplasia (BPH).

Patients who are currently symptomatic and have been diagnosed with BPH by a physician may qualify for this 20-week study. Patients must not be diabetic, must not have prostate cancer and must not have had any surgery to repair your prostate or treat your BPH. Patients will first undergo a phone screening to confirm their eligibility and interest and to rule out any exclusionary history or medications. Eligible patients will be scheduled to come in to the clinic to sign an Informed Consent Form. Patients will then undergo blood and urine tests, a complete physical examination and history and answer several questionnaires to determine their eligibility. Patients will have a total of at least 7-8 visits over 20 weeks to the clinic during this study.Qualified patients receive free study medication, free medical care (physical examinations, EKG, laboratory tests) for the duration of the study.

Patients must be willing to discontinue their current medications being taken for BPH for specified time periods before they become eligible. These include: Proscar, Saw Palmetto, and any "alpha-blocker" drugs.

Patients with high blood pressure must be on an acceptable medication that controls this condition.

Medications for other conditions may disqualify a patient from eligibility.Patients who are diabetic are not eligible for this study.

All patients will, at some time during the study, receive placebo (inactive substance). The study medication is given twice a day in liquid form under the tongue. There is a 33% chance that you would receive placebo for the duration of the study. Neither you nor your doctor will know which treatment you are receiving.

Eligibility Criteria:
* Have an enlarged prostate by DRE (digital rectal examination);
* Have a diagnosis of BPH;
* Have documented symptoms (frequency; urgency; nighttime urination; reduced flow);
* Have a documented urinary flow rate as required
Efficacy of Antidepressants in Chronic Back Pain

This 12 week placebo controlled clinical trial tests the individual and combined effects of an antidepressant medication and cognitive behavioral therapy for chronic back pain.

This is a 4 arm 12 week randomized clinical trial comparing the efficacy of 1) low concentration desipramine (\< 60 ng/ml); 2) cognitive behavioral therapy; 3) low concentration desipramine + cognitive behavioral therapy; and 4) placebo medication (benzotropine mesylate).

Eligibility Criteria:
Inclusion Criteria:

* Chronic back pain (daily pain for \> 6 months)

Exclusion Criteria:

* Major medical conditions which might contraindicate antidepressant treatment
Non-Interventional Post Marketing Surveillance Study To Observe The Safety And Efficacy Of Vfend® Tablet In Korea

This is a non-interventional study of voriconazole tablet in Korea which is mandated by the Korean government agency.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are indicated for voriconazole table according to the drug package insert.

Exclusion Criteria:

* None.
Predictive Role of [11C] Choline PET/CT on Survival in Prostate Cancer Patients With Biochemical Failure.

Several studies have shown that the PET/CT study with Choline is of great use in the restaging of patients with prostate cancer who present a recurrence of biochemical disease following primary treatment. Despite the large amount of literature in which the diagnostic accuracy of the method is highlighted in the identification of the recurrence of prostatic disease both in the case of local recurrence, lymph node recurrence and metastatic disease, there are to date no studies that evaluate whether PET /CT with choline may predict survival in patients radically treated for prostate cancer. The aim of the study is to evaluate the predictive role of choline PET/CT on the survival of patients with biochemical recovery of the disease during hormonal therapy.

This retrospective study will include adult patients affected by prostate cancer with biochemical recurrence of the disease following radical prostatectomy treatment and undergoing hormonal therapy who underwent, between 2004 and 2007, a PET/CT study with choline for the restaging of their disease.

The expected result is to establish how PET/CT with Choline can predict survival in patients who develop a biochemical recurrence of the disease during hormonal therapy. If this result is confirmed, PET/CT with Choline could be even more useful in the follow-up of patients radically treated for prostate cancer to plan the best therapeutic approach.


Eligibility Criteria:
Inclusion Criteria:

* patients who have been treated with radical prostatectomy;
* patients who present a progressive increase in PSA value during hormonal treatment.

Exclusion Criteria:

* patients\< 18 years