cyrilzakka/clinical-trials huggingface dataset:
Managing Patient Expectations in Pediatric Weight Management

As part of Children's Hospital Association's Focus on a Fitter Future III Obesity Task Force, this project will target patient and family expectations across the domains of nutrition, physical activity and behavior change/family support as a means of patient engagement and retention in pediatric weight management. This will be a prospective, non-randomized, uncontrolled, single-arm trial for children between 2 and 18 years of age and a parent/guardian, who are starting a pediatric weight management program/clinic in one of the participating centers. The parent/guardian and child if 12 years of age or older receive a survey at the first visit, which asks about their expectations and goals for the visit. This information will then be used as part of clinical care to tailor treatment. After 3 months, the parent/guardian and adolescent, if applicable, will receive a follow up survey asking about their progress in these areas.


Eligibility Criteria:
Inclusion Criteria:

* Subject conversant in English or Spanish
* Parent/guardian conversant in English or Spanish
* Patient aged 2-18 years

Exclusion Criteria (For Adolescent):

• Parent-reported cognitive issues preventing completion of the form, such as in-school aide\>50% of the school day; special education classes \>50% of school day
Screening of Liver Fibrosis in Adults Without Known Liver Disease

SIRIUS is the "serious" response to the prevalence of liver cirrhosis in Slovakia. We plan to screen adult Slovaks without acute or life-threatening comorbidity and without known liver disease (except from non-alcoholic fatty liver disease) for liver fibrosis by transient elastography (in community) or FIB-4 score (in outpatient clinics).

According to the Lancet Gastroenterology and Hepatology, Slovakia ranks at the top of the prevalence of liver cirrhosis in the world. Moreover, liver diseases are the leading cause of death in the age-group of 25 - 50 years-old. SIRIUS is the response conceived by the governing board of the Slovak society of hepatology with two main aims: to screen for liver fibrosis and to spread the largely unknown information in community, and primary-care sector.

Eligibility Criteria:
Inclusion Criteria:

* adult, written informed consent

Exclusion Criteria:

* unable to provide sufficient reliable information for any reason
* withdrawal of the consent, anytime
* acute illness (e.g. febrile, drunk, on antibiotics, trauma, myocardial infarction \< 2 months, operated on \< 2 months, other)
* chronic disease interfering with the endpoint (malignancy \< 2 years; decompensated chronic disease such as chronic heart disease with dyspnea New York heart Association NYHA 2+, Chronic obstructive pulmonary disease COPD GOLD B+, other)
* chronic liver disease other than non-alcoholic fatty liver disease without previous diagnosis of fibrosis
The Effect of Percutaneous Kirschner Wire Technique in Management of CPT Under One Year Old

The aim of this study was to investigate the effect of percutaneous kirschner wire in management of Congenital Pseudarthrosis of Tibia in children younger than 1 year of age. This study was to determine the union rates of congenital pseudarthrosis in children operated before 1 year of age to identify growth abnormalities in the affected limb ,including ankle valgus,tibia valgus,and shortening.

Currently, the timing of surgery for congenital pseudarthrosis of the tibia is a controversial issue. The investigators use percutaneous kirschner wire technique to manage the Congenital Pseudarthrosis of Tibia in children younger than 1 year of age.To investigate the effect of percutaneous kirschner wire in management of Congenital Pseudarthrosis of Tibia in children younger than 1 year of age. Bone uion rate,average time of healing, ankle valgus, limb length discrepancy, tibia axis alignment are recorded and evaluated.

Eligibility Criteria:
Inclusion Criteria:

* All patients did not undergo procedures
* Patients with Crawford type IV CPT treated with Percutaneous Kirschner wire techniques
* The age during surgery was less than 12 months old

Exclusion Criteria:

* Patients with pseudarthrosis of tibia caused by trauma,infection, etc
EMD and/or Bone Substitute for the Treatment of Class II Furcations

To clinically evaluate the treatment of mandibular class II furcation defects with enamel matrix derivative (EMD) and/or a bone substitute graft make of beta tricalcium phosphate/hydroxyapatite (βTCP/HA).

To clinically evaluate the treatment of mandibular class II furcation defects with enamel matrix derivative (EMD) and/or a bone substitute graft make of beta tricalcium phosphate/hydroxyapatite (βTCP/HA). Forty-one patients, presenting a mandibular class II buccal furcation defect, probing pocket depth (PPD) ≥ 4 mm and bleeding on probing, will be included. They will be randomly assigned to the groups: 1- EMD (n = 13); 2- βTCP/HA (n = 14); 3- EMD + βTCP/HA (n = 14). Relative gingival margin position (RGMP), relative vertical and horizontal attachment level (RVCAL and RHCAL) and PPD will be evaluated at baseline and 12 months. The mean horizontal clinical attachment level gain will be considered the primary outcome variable.

Eligibility Criteria:
Inclusion Criteria:

* Males and females, between 18-75 years of age;
* Presence of a mandibular molar with buccal class-II furcation defect, presenting PD ≥ 4mm, bleeding on probing (BOP), minimum (\<1 mm) or no gingival recession after non-surgical therapy;
* Good general health;
* Minimum interproximal bone loss (\< 2 mm).

Exclusion Criteria:

* Pregnant or lactating;
* Required antibiotic pre-medication for the performance of periodontal examination and treatment;
* Suffered from any other systemic diseases (cardiovascular, pulmonary, liver, cerebral, diseases or diabetes);
* Had received antibiotic treatment in the previous 3 months;
* Were taking long-term anti-inflammatory drugs;
* Had received a course of periodontal treatment within the last 6 months;
* Smokers.
Ketoacid Analogues Intradialytic Effect on Inflammation

this study tries to measure the effect of intradialytic ketoacid analogues on inflammatory parameters

this study will measure inflammation parameters:

* interleukin 6
* malnutrition inflammation score
* neutrophil lymphocyte ratio
* monocyte lymphocyte ratio
* thrombocyte lymphocyte ratio

the duration of intervention is 12 weeks

Eligibility Criteria:
Inclusion Criteria:

* patient who undergo hemodialysis two times a week

Exclusion Criteria:

* travelling hemodialysis
* acute conditions
* HIV patient
* acute infection
* stroke and immobilized patient
Serratus Block Versus Paravertebral Block for Post Thoracotomy Pain Relief

This double-blinded, randomized controlled study was done on 60 patients older than 18 years undergoing thoracotomy. Patients were allocated into two equal groups (30 patients each). Group S: Standard anesthesia in addition to SPB. II. Group P: Standard anesthesia in addition to PVB.


Eligibility Criteria:
Inclusion Criteria:

* patients more than 18 ys undergoing thoracotomy operation

Exclusion Criteria:

* morbid obesity (Body mass index \> 40)
* impossibility of anatomical structures US identification in a satisfactory way
* opioids treatment before surgery or substance abuse,
* sepsis and/or infection at the puncture sites
Identification of Gluten Sensitivity in Irritable Bowel Syndrome

The aim of our study will be to establish in how many subjects with gastrointestinal symptoms and previous diagnosis of irritable bowel syndrome (IBS), the clinical picture is attributable to non celiac gluten sensitivity (NCGS) or fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAPs) intolerance. For this purpose, all subjects with IBS will take a low FODMAPs diet, which implies the absence of cereals and consequently of gluten, and those presenting symptom improvement during this dietary treatment, will be exposed to a double-blind gluten or placebo challenge, to make a diagnosis of NCGS.

Study design:

For this study, patients with diagnosis of IBS performed by Rome IV criteria and followed as outpatients at the Clinical Nutrition Clinic of "Petrucciani" Nursing Home of Lecce (LE), Italy, will be enrolled.

At baseline, the enrolled subjects will follow a balanced normal-caloric low-FODMAP and gluten-free diet for a period of 4 weeks. At the end of the 4 weeks patients who did not experience an improvement in symptoms will be considered "non-responders" and discontinue the clinical trial. Only those subjects who had showed a significant improvement in symptoms, will be enrolled for the phase 2 of the study that includes a challenge with gluten or with placebo, as described by the Salerno criteria.

Eligibility Criteria:
Inclusion Criteria:

* a gluten-containing diet for at least six months before enrollment
* anti-transglutaminase antibodies (IgA and IgG) absence
* normal serum IgA levels
* prick and specific IgE tests for wheat allergy negative

Exclusion Criteria:

* celiac disease
* wheat allergy
* chronic intestinal inflammatory diseases
* psychiatric disorders
* major abdominal surgery (in particular intestinal resections)
* diabetes mellitus
* previous anaphylactic episodes
* gluten-free diet in the previous six months
* pregnant or lactating women.
Testing Messages to Promote HPV Vaccination

Human papillomavirus (HPV) is the most common sexually transmitted infection worldwide. Hispanic women have the highest rates of HPV-related cervical cancer compared to all other groups in the U.S. Previous research has delineated several unique barriers to HPV vaccination among Hispanic women, suggesting that interventions that focus on addressing these barriers may improve HPV vaccination compliance in this population. To address some of these unique barriers, an online tailored messaging intervention was developed and tested. Initial analyses demonstrate that participants exposed to an online intervention demonstrated higher intentions to vaccinate for HPV after viewing the informational materials. The next phase of the project will be comprised of promoting use of the online intervention to the general public through the use of theory-based, pretested messages delivered via advertisements on Facebook and Twitter. Specifically, messages will be targeted based on differences between Hispanic parents of adolescents and Hispanic young adults. Previous research has explored the use of the Extended Parallel Processing Model as a theory to guide messages designed to promote health behaviors. The current study extends this work in the area of HPV prevention. Specifically, it seeks to examine the use of this theory as a means to stimulate information seeking behavior in the form of use of the previously developed online intervention that provides information about HPV. We also hope to make a significant contribution to research demonstrating the importance of targeting messages based on differences in population characteristics. Additionally, this study seeks to build on research examining the use of social media sites as a means for implementing health interventions and promoting positive health outcomes. Ultimately, the current study seeks to improve both the HPV vaccination decision-making process and HPV vaccination rates. If this was achieved among the Hispanic population it could substantially decrease disparities in cervical cancer and other HPV-related diseases.


Eligibility Criteria:
Inclusion Criteria:

* For parents eligibility criteria were being: 1) of Hispanic or Latino origin, 2) 18 years or older, 3) a parent or guardian of a child ages 11-17 who had not been vaccinated for HPV.
* For young adults eligibility were being: 1) of Hispanic or Latino origin, 2) 18-26 years of age (vaccine eligibility at the time of data collection, and 3) having not been vaccinated for HPV.

Exclusion Criteria:

* Being under 18 years of age
* Not identifying as Hispanic or Latino
* For parents, having no children ages 11-17 or having only children already vaccinated for HPV
* For young adults, having already been vaccinated for HPV or no longer being eligible due to age (\>26)
A Study of MTPS9579A in Participants With Refractory Chronic Spontaneous Urticaria

This pilot and dose-ranging study will evaluate the efficacy, safety, and pharmacokinetics of MTPS9579A compared with placebo in participants with chronic spontaneous urticaria (CSU) refractory to antihistamines. This study comprises two parts. In Part 1, participants will be randomized to receive MTPS9579A or placebo. On the basis of positive results from Part 1, a dose-ranging Part 2 may be opened, where participants will be randomized to receive one of four MTPS9579A doses or placebo.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CSU refractory to sgH1-AHs at the time of randomization
* Demonstrated ability to comply with the required use of the eDiary for the duration of the study
* For patients on H2 antihistamines or LTRAs for non-CSU indications, treatment at a stable dose for \>=2 weeks prior to screening, with no anticipated changes throughout duration of study, including the screening period
* For women of childbearing potential: agreement to remain abstinent or use contraception
* For men: agreement to remain abstinent or use a condom, and agreement to refrain from donating sperm

Exclusion Criteria:

* Previous participation in a clinical trial of MTPS9579A
* Chronic urticaria with known cause or other disease with symptoms of urticaria or angioedema
* Other skin disease associated with chronic itching
* Uncontrolled disease where flares are commonly treated with systemic corticosteroids
* History or evidence of any clinically significant medical condition/disease or abnormalities in laboratory tests that, in the investigator's judgment, preclude the patient's safe participation and completion of the study, or interferes with the conduct and interpretation of the study
* History of anaphylaxis without clearly identifiable avoidable antigen
* History of anaphylaxis to any biologic therapy for any indication
World Data on Ambroxol for Patients With GD and GBA Related PD

Ambroxol hydrochloride is an oral mucolytic drug available over-the-counter for many years as cough medicine. In 2009 it was found to also act as a pharmacological chaperone (PC) for mutant glucocerebrosidase, albeit in a several-fold higher dose. Unfortunately, due to its low cost, there have been no pharma-driven clinical trials to establish the use of ambroxol. Thus, data are needed on the safety and efficacy of ambroxol for patients with Gaucher disease (GD).

The three decades of success of enzyme replacement therapy (ERT) for patients with type 1 Gaucher disease (GD1) have been just a partial success to those patients with the more severe neuronopathic forms, particularly the children with myoclonic epilepsy or the infants with type 2 GD.

Ambroxol hydrochloride is an oral mucolytic drug, available over-the-counter (OTC) for many years as cough medicine. In 2009 it was found (in-vitro) to also act as a pharmacological chaperone (PC) for mutant glucocerebrosidase (GCase), albeit in a several-fold higher dose . Unfortunately, due to its low cost, there have been no pharma-driven clinical trials to establish the use of ambroxol.

In an attempt to provide the proof of concept to the potential use of Ambroxol as PC for patients with GD, the Gaucher Clinic at Shaare Zedek Medical Center in Jerusalem, Israel, has treated 12 adult patients with GD1, all untreated with any specific treatment for GD \[whether ERT or substrate reduction therapy (SRT),\] with Ambroxol at the OTC dose of 150mg/day for a period of 6 months; this was not a formal clinical trial, but rather an audit of a series of patients receiving this drug via the employment of the Israeli Ministry of Health Form 29c to prescribe it for an off-label indication. A single patient, the thinnest of the group with a BMI of 17.1, achieved a robust response relative to baseline similar to ERT.

In 2016, a group from Japan has demonstrated impressive neurological response using high-dose Ambroxol (a marked decrease in seizure frequency, improvement of myoclonus, ability to walk for a bedridden patient, improvement in the latency of I-V waves and threshold of ABR) with dramatic change in daily activities and quality of life (QOL). These encouraging results, that were confirmed in a larger series, yet unpublished, have further led to the conduction of an investigator-initiated-research (IIR) clinical trial in London by Prof A Schapira, which has recently been published (January 13, 2020 JAMA Neurology), wherein newly diagnosed Parkinson patients received high dose Ambroxol, with good safety results

Eligibility Criteria:
Inclusion Criteria:

* patients with Gaucher disease type 1,2 or 3(a,b,c).
* patients with GBA-related Parkinson disease.

Exclusion Criteria:

* None.
The Skills, Confidence & Preparedness Index (SCPI)

The LMC Skills, Confidence and Preparedness Index (SCPI) is a tool that was developed by diabetes specialists to individualize the education/support that a healthcare provider delivers to patients with diabetes. It has been shown to have high reliability, validity and generalizability. This study assessed the validity and reliability of a revised, final version of the SCPI in a large sample of patients with type 1 and type 2 diabetes, as well as the clinical responsiveness of the SCPI to a diabetes self-management education intervention in a smaller cohort of patients with poor glycemic control.

Canadian experts in diabetes care developed the Skills, Confidence \& Preparedness Index (SCPI) to assess diabetes self-management in patients. The SCPI is web-based, gives immediate feedback to the healthcare provider, and is associated with glycemia. The SCPI was designed to allow a healthcare provider to individualize the education/support by assessing the three critical dimensions of self-management: knowledge of a skill; confidence in ability to change a behavior; and preparedness to begin implementing the behavior change. Two previous validation studies showed that the SCPI has high internal consistency, reliability, generalizability, and external validity.

Following further focus groups with healthcare providers and patients, the SCPI questions and response scale were edited to further optimize clarity. This study assessed the validity and reliability of a revised, final version of the LMC SCPI in a large sample of diabetes patients, as well as clinical responsiveness of the SCPI to a diabetes self-management education (DSME) program intervention.

This study recruited type 1 and type 2 patients from the waiting rooms of seven LMC Diabetes \& Endocrinology specialist clinics in Ontario, Canada. Patients completed the SCPI electronically and their demographic and health information was retrieved from their electronic medical records. A smaller cohort of patients with uncontrolled glycemia were enrolled into a DSME program. Participants completed the SCPI at their baseline visit and their individual results were incorporated into the care paths that were then customized for that participant. The DSME program provided five to seven visits with a diabetes educator over three to four months. Patients completed the SCPI again at their final visit.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of type 1 or type 2 diabetes
* Age ≥ 18 years
* Ability to read English
* Duration of diabetes ≥ 6 months (DSME cohort only)
* A1C ≥ 8.0% (DSME cohort only)

Exclusion Criteria:

-
Biliary Cannulation During Endoscopic Retrograde Cholangiopancreatography: Precut Versus Conventional Cannulation

Endoscopic sphincterotomy is now an established method for removal of common bile duct calculi and treatment of papillary stenosis, the sump syndrome and certain cases of ampullary carcinoma. It is also generally performed prior to biliary stent placement .Anatomical variations, papillary stenosis, impacted stones, ampullary tumors, duodenal diverticula, and post-gastrojejunostomy states are some of the reasons behind difficult common bile duct (CBD) cannulations . In these situations, the success of CBD cannulation can be enhanced slightly by using the various accessories designed for this purpose.The aim of this study is to prospectively compare conventional approach and needle knife fistulotomy in cannulation of ampulla of Vater during endoscopic retrograde cholangiopancreatography regarding procedure-related complications as failure of cannulations, bleeding and perforation and postoperative complication

The aim of this study is to prospectively compare conventional approach and needle knife fistulotomy in cannulation of ampulla of Vater during endoscopic retrograde cholangiopancreatography regarding procedure-related complications as failure of cannulations, bleeding and perforation and postoperative complication This a prospective randomized controlled trial comparing two groups of patients who undergo endoscopic retrograde cholangiopancreatography for obstructive jaundice in Gastrointestinal Surgical center, Mansoura University, Egypt. From January 2014 to December 2014.

Group A consists of 50 patients who will undergo conventional approach and group B consists of 50 patients who undergo needle knife fistulotomy for cannulation of the ampulla of Vater. Randomization was done by paramedical personnel in the ERCP unit by taking a number from an envelope.

Data will be registered in a specially prepared sheet for the purpose of the study. Registered data will include: duration of cannulation, number of trials for cannulation, number of pancreatic cannulation, bleeding during cannulation and its management, need to convert to the other approach in cannulation.

Data also included postoperative hospital stay, serum amylase level and postoperative complications as pancreatitis, perforation, bleeding and cholecystitis. Pancreatitis will be also graded according to its severity depending on the duration of hospital stay.

Eligibility Criteria:
Inclusion Criteria:

* all patients (no limit of age) required ERCP calculator and malignant obstructive jaundice

Exclusion Criteria:

* unfit patients history of gastrectomy bleeding tendency larg tumour infiltrating the duodenum
Comprehensive Analyses of Multidetector-row Cardiac Computed Tomography Data in Koreans

64 channel multidetector-row Computed Tomography (CT) has been introduced for use in the diagnosis of coronary heart disease. The investigators aimed to characterize coronary artery disease in type 2 diabetes mellitus and metabolic syndrome, and in particular plaque natures depending on different status of metabolic diseases. The investigators also aimed to analyze the risk factors associated with number and severity of stenosis as well as plaque characteristics using logistic regression models.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older

Exclusion Criteria:

* pregnant women
* patients with chronic kidney disease (Cr\>2.0)
The Effect of Pandemic on Children With Cerebral Palsy

Cerebral Palsy (CP), is the most common cause of physical disability that begins in childhood and lasts throughout life, affecting 1 in 500 newborns, with an estimated prevalence of 17 million worldwide.

Social isolation, economic conditions, interruption of treatments, etc. may cause physical, mental, behavioral and psychosocial changes in children with cerebral palsy. Discontinuing regular physiotherapy can worsen functional skills and cause complications in children with cerebral palsy. Our aim in this study is to investigate the sustainability of the treatments of children with cerebral palsy during the pandemic period, their physical and psychosocial effects, and the relationship between their parents' fear of covid-19.


Eligibility Criteria:
Inclusion Criteria:

* Parents of children under the age of 18 with cerebral palsy who applied to our hospital between 01.01.2014-31.01.2021

Exclusion Criteria:

* Parents of Cerebral Palsy Patients over 18 years of age
* Parents who cannot be reached by phone
* Parents who do not agree to fill out the questionnaire