cyrilzakka/clinical-trials huggingface dataset:
Ghrelin and Obestatin in CKD Children

Protein energy wasting (PEW) is a complex syndrome associated with different underlying illnesses and characterized by loss of muscle, with or without loss of fat. It is a highly prevalent condition among patients with chronic kidney disease (CKD), associated with increased morbidity and mortality.

The pathophysiology of PEW in CKD is multifactorial and not yet completely understood. The potential role in uremic PEW of two of hormones involved in orexigenic/anorexigenic balance, ghrelin and obestatin, both derived from the ghrelin gene (GHRL), has been investigated in adults and, less extensively, in children. Aim of our study was to measure AG, UAG and obestatin concentrations in children with CKD and to assess their potential contribution to the development of pediatric uremic PEW.

This is a cross-sectional case-control study. Between January 2013 and June 2015 children and adolescents aged 5-20 years, referred to the Pediatric Nephrology, Dialysis and Transplant Unit of Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico - Milan, Italy were enrolled. Subjects with CKD stages II-V under conservative treatment (CKD-CT), or undergoing hemodialysis treatment (CKD-HD), or being renal transplant recipients (RTx) were included in the study. Data about age, primary renal disease and concomitant medications were collected for each subject.

CKD stages were defined using the K/DOQI criteria of the US National Kidney Foundation.

Control subjects were outpatients of the Pediatric Surgery Unit of the Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico - Milan, Italy, aged 1-20 years, who underwent a blood sample collection before a surgical intervention for the treatment of minor diseases that did not impair renal or endocrine function (i.e. phimosis, hydrocele, inguinal hernia).

Biochemical and hormonal parameters Blood samples were collected between 7:00 and 8:00 a.m. after an overnight fast, and before dialysis in CKD-HD patients. Routine biochemical parameters \[creatinine, urea\] were measured in all subjects. Glomerular filtration rate was estimated (eGFR) by the Schwartz formula, with k = 0.413, as appropriate for standardized creatinine.

In all subjects, plasma AG and UAG concentrations were measured by the Human Acylated / Unacylated Ghrelin ELISA kit (BioVendor, Laboratorni Medicina a.s., Brno, Czech Republic) according to manufacture procedures, and AG/UAG ratio was calculated. Serum obestatin concentrations were determined using the Human Obestatin ELISA kit (BioVendor, Laboratorni Medicina a.s., Brno, Czech Republic).

Eligibility Criteria:
Inclusion Criteria:

* the CKD-HD patients should have been on hemodialysis treatment for at least 3 months
* the RTx patients should have received renal transplantation at least 6 months before

Exclusion Criteria:

* treatment with growth hormone
* the presence of neurologic disability or syndromic diseases affecting per se food intake
* for controls: they should have no history of chronic diseases and should not receive any medication. They should be on unrestricted diet.
Prostatic Artery Embolization for Benign Prostatic Obstruction

The aim of this study is to investigate the safety and efficacy of prostatic artery embolization (PAE) for patients who refuse or are not eligible for surgery with moderate-severe lower urinary tract symptoms or indwelling catheter secondary to benign prostate obstruction due to benign prostatic hyperplasia.

This is a prospective study investigating the safety and efficacy of PAE for patients who refuse or are not eligible for surgery and who suffers from moderate-severe lower urinary tract symptoms or indwelling catheter secondary to benign prostatic obstruction due to benign prostatic hyperplasia. It may form the grounding for further research in the shape of a larger randomised clinical trial.

Our hypothesis is that PAE will eliminate the need for indwelling catheter and improve IPSS 6 months post-procedure.

1, and 6 months follow-up.

Main outcome Ability to void after removal of indwelling catheter

Secondary outcomes International Prostate Symptom Score (IPSS) Quality of Life (QoL) International Index of Erectile Function (IIEF) Prostate volume Peak void flow (Qmax) Post-void residual (PVR) Classify complications according to Society of Interventional Radiology (SIR) guidelines for reporting Prostate-specific antigen (PSA)

Eligibility Criteria:
Inclusion Criteria:

* Indwelling catheter secondary to benign prostatic hyperplasia (BPH) or
* Moderate-severe Obstructive LUTS secondary to BPH refractory to medical treatment
* Unsuitable for TURP or refuse surgery

Exclusion Criteria:

* Bladder dysfunction(and known neurological conditions affecting bladder function)
* Urethral strictures
* Bladder neck contracture
* Known sphincter anomalies
* Big bladder diverticulum or stones
* Kidney insufficiency (eGFR \< 45)
* Coagulation disturbances
* Severe atheromatous or tortuosity of arteries
* Allergy to contrast medium
* Unable to undergo MR imaging
* Urological malignancy
Endoscopic Versus Conventional Septoplasty in Treatment of Deviated Nasal Septum

This study aims to compare the two techniques of relieving nasal obstruction, and its efficacy in the relief of headache, hyposmia and post-nasal drip and nasal synechiae formation and /or other postoperative complications following each techniques of surgery.

A straight septum is found not to be the dominant but the exception.

A deviated septum can be asymptomatic or can cause functional and cosmetic abnormality. it also can become symptomatic at any age. Deviated nasal septum not only causes breathing difficulties but also causes improper aeration of para nasal sinuses leading to infection, so any functional or cosmetic disturbance caused by a deviated septum should be treated. Different surgeries have been proposed for the correction of deviated nasal septum. Initially, submucosal resection of septum was proposed but was later replaced by septoplasty .

Septoplasty is the procedure of choice in nasal obstruction caused by septal deviation resistant to medical treatment. It also improves access to the medial meatus in sinus surgery and other nasal and sinus procedures, such as cosmetic rhinoplasty and functional endoscopic sinus surgery(FESS)

Modern septoplasty techniques were initially described separately in the early twenties century by Killian and Freer. It is conventionally performed under direct visualization using a headlight and nasal speculum. However, this method has the drawbacks of relatively poor illumination and accessibility and no magnification, calling for a larger incision and elevation of larger flaps often on both sides of the septum. As a result, there are higher chances of over-resection and over manipulation. Endoscopic septoplasty has been commonly performed since the development of endonasal surgery and as as an alternative to the conventional technique. In this study the I investigators aim to compare the two techniques of relieving nasal obstruction, and its efficacy in the relief of headache, hyposmia and post-nasal drip and nasal synechiae formation following each techniques of surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with deviated nasal septum with persistent symptoms for at least 3 months and had not responded to maximal medical management.
* patients of deviated nasal septum cased by either childbirth trauma or recent

Exclusion Criteria:

1. patients of asymptomatic deviated nasal septum
2. patients who had a history of previous nasal surgery
3. patients who had other causes of nasal obstruction
4. patients who had received radiotherapy of head and neck region.
MRI Study After Arterial Switch Operation in Patients With Transposition of the Great Arteries

This study involves adolescents operated with arterial switch procedure for transposition of the great arteries during the neonatal period. The purpose is to evaluate the coronary arteries and direct and indirect findings of coronary artery disease/complications with 3 tesla magnetic resonance imaging.

This study involves adolescents operated with arterial switch procedure for transposition of the great arteries during the neonatal period. The patients were operated with two different methods of re-implantation of the coronary arteries ("trap-door"/non-"trap-door", see description below).

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of transposition of the great arteries with or without ventricular septum defect
* Surgically corrected during neonatal period with arterial switch procedure

Partial or total Exclusion Criteria:

* Heart arrhythmias
* Known allergic reaction to gadolinium based contrast media
* Reduced renal function (below 60 ml/min/1,73m2)
Soft Tissue Graft Over Immediately Placed Dental Implant in Maxillary Molar Socket

Compare between free tissue graft of buccal pad of fat BFP and free palatal gingival tissue graft for primary soft tissue closure over immediately placed dental implant

Buccal pad of fat BFP and free palatal gingival tissue graft over immediately placed dental implant

Eligibility Criteria:
Inclusion Criteria:

* class one molar extraction socket

Exclusion Criteria:

* pregnant females psychiatric problems
Evaluation of Gut Permeability in Patients Affected by Obesity and NAFLD: Influence of Ketogenic Diet.

This study is open label, with one arm only. In this study will be enrolled patients with obesity (BMI more than 30). Aim of the study is to determine the influence (if any) of a very low calorie ketogenic diet (VLCKD) on gut permeability and liver steatosis.

The first objective is to examine the influence of obesity on the prevalence and severity of impaired intestinal permeability and hepatic steatosis.

Intestinal permeability means the ability of the intestinal barrier to block the passage of substances potentially harmful to our body.

The second objective is to evaluate whether a low-calorie and ketogenic dietary intervention, lasting 6 weeks, can change intestinal permeability and hepatic steatosis


Eligibility Criteria:
Inclusion Criteria:

1. BMI ≥ 30 Kg/m2 or abdominal circumference (waist) \>94 cm in men and \>80 cm in women (IDF criteria for the definition of abdominal obesity) with or without the features that characterize the metabolic syndrome
2. Age range between 18 and 70 years, both sexes
3. Diagnosis of hepatic steatosis, formulated on the basis of fibroscan \[CAP (controlled attenuation parameter) \> 238 dB/m(decibel/meter)\], and other recognized criteria (FLI - Fatty Liver Index , FIB-4 - Fibrosis-4 index, NFS - NAFLD fibrosis score).

Exclusion Criteria:

1. Normal and underweight subjects
2. Presence of any pathology that may affect the presence of altered intestinal permeability or steatosis, apart from pathologies that represent inclusion criteria
3. Treatment with any device, pharmacological or not, that can affect intestinal permeability and liver metabolism and, therefore, the presence of steatosis
4. Pregnancy or lactation
Paclitaxel-coated Balloons in Femoral Indication to Defeat Restenosis

The aim of the study is correlating efficacy of the treatment to the proportion of paclitaxel-dose supplied by the catheter. Forty-five patients each will be treated by paclitaxel-coated or uncoated conventional balloon catheters in randomized order in 3 study centers. Main inclusion criteria are Rutherford class 2 - 5, ≥70% stenosis or occlusion in the superficial femoral or popliteal artery, main exclusion criteria are related to the use of paclitaxel and the need for follow-up examinations. Either clinical or angiographic follow-up examinations are planned 6, 12 and 24 months following the intervention. Primary endpoint is 6-month angiographic late lumen loss. Secondary endpoints are further angiographic and clinical efficacy and various safety criteria.

Paclitaxel-coated balloons have been shown to reduce late lumen loss, restenosis rates and the need for repeat target lesion revascularization compared to conventional uncoated balloon catheters. The aim of the study is correlating efficacy of the treatment to the proportion of paclitaxel-dose supplied by the catheter. To this end paclitaxel loss of catheters in the introductory sheaths and residual paclitaxel on used balloons will be determined and correlated to individual data indicating inhibition of neointimal proliferation. According to the study protocol 45 patients each will be treated by paclitaxel-coated or uncoated conventional balloon catheters in randomized order in 3 study centers. Main inclusion criteria are Rutherford class 2 - 5, ≥70% stenosis or occlusion in the superficial femoral or popliteal artery, 3 to 30 cm of length; beyond common contraindications against PTA main exclusion criteria are related to the use of paclitaxel and the need for follow-up examinations. Patients will be blinded against treatment. Blinding of investigators after assignment of a patient to a treatment is not possible due to differences in the appearance of coated and uncoated catheters. Either clinical or angiographic follow-up examinations are planned 6, 12 and 24 months following the intervention. Primary endpoint is 6-month angiographic late lumen loss evaluated by a blinded independent core lab. Secondary endpoints are interventional success rate, restenosis rates, minimal lumen diameter, target lesion revascularization, change in Rutherford class, change in ankle-brachial-index, major amputations, a composite safety endpoint (defined as MAE =death of any cause, target limb amputation, clinically / DUS driven TLR) and all kinds of serious adverse events possibly related to the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with PAOD, Rutherford stage 2-5, Occlusion or stenosis \>70% in diameter of at least 3 cm length in the superficial femoral artery and/ or popliteal artery

Exclusion Criteria:

* Acute thrombus or aneurysm in the index limb/ vessel
* Doubts in the willingness or capability of the patient to allow follow up examination
The Effect of Patient Discharge From the Maternal and Fetal Medicine Unit With Receiving a Discharge Letter Later Using the Apollo App on Discharge Data, Safety and Patient Satisfaction

Women admitted to the maternal and fetal medicine unit are often discharged after a short hospital stay. The routine work in the department is prioritized such that the discharge letter are written. In the last year the Apollo mobile application (app) was introduced. It contains general information on the medical center and the maternal and fetal unit department as well as the medical records, laboratory results and summary and discharge letters. The Apollo app is used in the maternal and fetal unit in the discharge process so the patient can receive the discharge letter in the app and does not need to wait until the discharge letter is written.

It is not known whether this process is more effective than the regular discharge process and patients' satisfaction was not assessed previously.

In the present study we will compare discharge data, satisfaction and safety of discharging using the Apollo app versus the routine process.


Eligibility Criteria:
Inclusion Criteria:

* Women who are admitted to the maternal and fetal medicine unit with the intention to be discharged before delivery
* 18 years old and older
* Consent to participate
* Owner of a smart phone
* Consent to download the Apollo app

Exclusion Criteria:

* Delivery during her admission
* Doesn't own a smart phone
* Refusal to download to Apollo app
* Refusal to participate
Usefulness and Feasibility of Ultrasound in Office Laryngology Procedures

Investigators will assess the usefulness of using ultrasound in office procedures for laryngology interventions. Participants who qualify will be adults who are undergoing superior laryngeal nerve block, injection laryngoplasty, swallowing evaluation, voice evaluation and voice therapy.


Eligibility Criteria:
Inclusion Criteria:

* US-Guided Injection for Neurogenic Cough:

  1. Age over 18 years
  2. Recommended to undergo superior laryngeal nerve block
* US-Assessment of Superior Laryngeal Nerve Anatomy

  1. Age over 18 years
  2. No cough complaints
* US-Assessment of Injectate Volume:

  1. Documentation of unilateral vocal fold paresis/paralysis or atrophy
  2. Age over 18 years
  3. Recommended to undergo injection laryngoplasty
* US-Assessment of Swallow:

  1. Age over 18 years
  2. Presents with swallowing complaints
* US-Assessment of Normal Swallow:

  1. Age over 18 years
  2. Presents without swallowing complaints
* US-Assessment of Voice:

  1. Age over 18 years
  2. Undergoing evaluation of voice problems

Exclusion Criteria:

1. Age under 18 years and over 99 years
2. Open neck wound including tracheostomy
Oraverse Versus Laser

clinically assess the reversal of articaine 4% of two different concentration of vasoconcentration soft-tissue local anesthesia in pediatric dentistry using Diode Laser and Oraverse

Patients will be divided randomly into two groups (20 patients in each group) Group (1): Patients will be undergoing anesthesia revision by diode laser Group (2): Patients will be undergoing anesthesia revision by oraverse. Then each group will be subdivided into 2 subgroups (10 patients each) according to type of local anesthetic agent into:

subgroup 1: Articaine 4% with 1:100000 epinephrin \&Subgroup 2: Articaine 4% with 1:200000 epinephrin After 30 min of injection corresponding to approximate time of treatment, the patient in each group will be exposed to the reversal agent which may be diode laser or oraverse.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who need to be treated under anesthesia by injecting mandibular first molar infiltration.
2. Cooperative children aged 6 to 10 years old with the ability to understand and respond to the sensation of soft tissue -
Nepal Elimination of Trachoma Study

The main purpose of this study is to determine if ocular Chlamydia trachomatis infection can be eliminated in communities in Nepal following mass antibiotic distributions with azithromycin. The investigators will study both clinical trachoma and ocular C. trachomatis infection. The overall objective is to determine if the current World Health Organization (WHO) treatment strategy results in elimination of trachoma and infection.

1. The investigators hypothesize that 24 communities in Kanchanpur, Kailali, and Achham districts of Nepal which receive mass antibiotic treatments will achieve elimination of trachoma as a public health problem (clinical disease \<5% in children 1-9 years old) more frequently than communities which have not received antibiotic treatments.
2. The investigators hypothesize that infection with C. trachomatis will be undetectable in all members within a community following mass treatment as determined by the most highly sensiti1. The investigators hypothesize that 24 communities in Kanchanpur, Kailali, and Achham districts of Nepal which receive mass antibiotic treatments will achieve elimination of trachoma as a public health problem (clinical disease \<5% in children 1-9 years old) more frequently than communities which have not received antibiotic treatments.

2. The investigators hypothesize that infection with C. trachomatis will be undetectable in all members within a community following mass treatment as determined by the most highly sensitive nucleic acid amplification testing available (mRNA-based APTIMA and DNA-based AMPLICOR PCR).ve nucleic acid amplification testing available (mRNA-based APTIMA and DNA-based AMPLICOR PCR).

Here we evaluate whether ocular chlamydia infection and clinical trachoma are eliminated from 24 communities in western Nepal following a mass antibiotic distribution program. It is unknown if repeated treatments should continue or can be stopped thereby minimizing side effects and the high cost of medicine distribution. The investigators plan to randomize individuals to two groups to study the effects of a mass antibiotic distribution program: 1) treatment of antibiotics and 2) delayed treatment of antibiotics (after 4-6 months).

Eligibility Criteria:
Inclusion Criteria:

* Children aged 1-9 years
* Children who live in Kailai, Kanchanpur, or Achham Districts of Nepal

Exclusion Criteria:

* All individuals who are allergic to macrolides
* All pregnant woman
* All neonates
The Effect of Probiotics on Exacerbation of Inflammatory Bowel Disease Exacerbation (Crohn's Disease)

Inflammatory Bowel Disease (IBD) is an immune mediated chronic intestinal condition. It includes ulcerative colitis (UC) and Crohn's disease(CD). probiotics have been shown to be effective in varried clinical conditions ranging fron infantile diarrhea, necrotizing enterocolitis,helicobacter pylori infections, etc.

This is a prospective study that will enroll 50 patients with Crohn's disease.Each patient will get the study medication for 6 weeks and will be evaluated twice- before enrollment and after 6 weeks of treatment.

Eligibility Criteria:
Inclusion Criteria:

* patients with Crohns' disease who are stable or have mild acute exacerbations that do not necessitate treatment with systemic corticosteroids

Exclusion Criteria:

* pregnant women, under 18 years or over 60 years,
* patients with known ulcerative colitis,
* patients with any cancer,
* patients with heart failure
Treatment of Acne Vulgaris With Doryx Tablets Compared to Doxycyline Hyclate

Randomized, multi-center, open label, active-comparator study to compare the efficacy and tolerability of Doryx Delayed Release Tablets to doxycycline hyclate in patients with moderate to severe acne vulgaris.

Efficacy of Doryx Delayed Release Tablets to doxycycline hyclate will be assessed using an Investigator's Global Assessment (IGA) score and the absolute change from baseline to 12 weeks in inflammatory lesion count in patients with moderate to severe facial acne vulgaris. Additionally, the absolute change from baseline to 12 weeks in non-inflammatory lesions count of Doryx Delayed Release Tablets compared to doxycycline hyclate will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Must be 12 years of age or older.
* Has a diagnosis of facial acne vulgaris with no more than two nodules on the face.

Exclusion Criteria:

* Is allergic to tetracycline-class antibiotics or to any ingredient in the study medication.
* Has a history of pseudomembranous colitis or antibiotic-associated colitis.
* Has a history of hepatitis or liver damage or renal impairment.