cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Efficacy of Duodenal Prostheses Not Covered Over 6 Years

To assess the efficacy of duodenal prostheses for duodenal stenosis established for endoscopic pyloric or duodenal stenosis on dysphagia

Duodenal prostheses have become, since the 2000s, the first-line treatment of unresectable duodenal tumoral stenosis. The technical success is greater than 90%, however the endoscopic revisions that are duodenal or biliary are frequent. The IPC as a center of interventional endoscopy is very often in charge of these stenoses. We wanted to evaluate the efficiency and the duration of this effectiveness in current situation. Is there still room for gastrojejunal gastrojejunal surgery or for the development of endoscopic gastrojejunal anastomoses?

Eligibility Criteria:
Inclusion Criteria:

* Any symptomatic duodenal stenosis with symptomatic duodenal duodenal prosthesis between 2010 and 2017.

Exclusion Criteria:

* Benign stenosis or covered metallic duodenal prosthesis (usually indicated for benign disease)
Real-Time PCR for the Detection of Vaginal Group B Streptococcus Carriage: a Medico-Economic Study

Group B streptococcus infections may be serious for the neonates. The infection can occur during the birth, by contact with the genital area. That is why the detection of this bacteria is systematically realised in pregnant women between 34 and 37 weeks of amenorrhea in order to give prophylactic antibiotic treatment in case or positive carriage. This strategy presents 2 disadvantages : (1) detection of the group B streptococcus at 34 and 37 weeks of amenorrhea in not predictive of a carriage at delivery, (2) many pregnant women escape from systematic screening, leading to a systematic antibiotic treatment, which means useless costs, and useless antibiotic exposure with resistant bacteria selection. Real time polymerase chain reaction (PCR) allows a rapid detection anytime with no specific microbiological qualification. The aim of the study is to assess the economic outcomes of this strategy and the epidemiological values for St Etienne hospital.


Eligibility Criteria:
Inclusion Criteria:

* women giving birth

Exclusion Criteria:

* planned caesarian
* minor
* cervical diameter \> 5 cm
* women giving birth at less than 35 weeks of amenorrhea
* recent antibiotherapy
Enteral Nutrition Product in Mild Acute Pancreatitis

The aim of the study is to evaluate the beneficial effects of the administration of enteral nutrition product with milk proteins, monounsaturated fatty acids and low dextrose equivalent maltodextrin and enriched in eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA) and medium chain triglycerides (MCT) in patients with mild acute pancreatitis. All this against other specific product.

The main objectives of this project are:

* Comparing the tolerance of both preparations.
* Comparing the evolution of nutritional status in both groups.
* Comparing the evolution of inflammatory parameters in both groups

Oral administration of an oligomeric formula with milk proteins, mainly whey protein partially hydrolysate, monounsaturated fatty acids (AGM) and low dextrose equivalent maltodextrin and enriched in polyunsaturated fatty acids (PUFA) of omega-3 series, EPA and DHA, and MCT designed for nutritional support of patients with compromised intestinal function, to maintain or improve nutritional status and reduce the inflammatory response in undernourished patients with mild acute pancreatitis, compared with oligomeric enteral nutrition product, low in fat and rich in glutamine.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 with Mild Acute Pancreatitis.

Exclusion Criteria:

* Patients with Several Acute Pancreatitis
* Patients with life expectancy less than 48 hours.
* Renal (creatinin \> 2,5 mg/dl) or kidney failure (GOT/GPT\>2 from laboratory normal value)
* Patients with diabetes mellitus prior to acute pancreatitis.
* To take part in another study.
* Pregnant patients
* Informed consent absence.
Correlation Between Various Adipokines and Vascular Inflammation Measured by Positron Emission Tomography (PET) With 18F-fluoro-deoxyglucose (FDG) (18FDG-PET)

The inflammatory state and composition of atherosclerotic plaques are considered the main contributing factors responsible for acute cardiovascular events, rather than the degree of stenosis. Recently, positron emission tomography (PET) with 18F-fluoro-deoxyglucose (FDG) has been suggested as a promising novel imaging technique to identify the inflammatory state of atherosclerotic plaque. Recently, a few clinical studies showed that circulating A-FABP level had a close relation with the development of atherosclerosis in human. Therefore, in the present study, the investigators examined the relationship between circulating A-FABP and vascular inflammation of carotid arteries measured using FDG-PET in healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers for visiting routine medical check in our clinic

Exclusion Criteria:

* History of cardiovascular disease (myocardial infarction, unstable angina,stroke, or cardiovascular revascularization)
* Diabetes
* Hypertension
* Malignancy
* Severe renal or hepatic disease
* Subjects taking medications that might affect inflammation such as NSIAD and statin
Effect of Hyaluronan-enriched Medium on the Cumulative Ongoing Pregnancy Rate.

Assessing whether the use of hyaluronan-enriched transfer medium can increase the cumulative ongoing pregnancy rate


Eligibility Criteria:
Inclusion Criteria:

* Patients with own oocytes/embryos;
* Patients with female age at 1st OR in the study \<40 year;
* Patients planned for a 2nd oocyte retrieval, with no clinical ongoing pregnancy after the previous oocyte retrieval
* Patients planned for a 3rd oocyte retrieval with no clinical ongoing pregnancy after previous oocyte retrievals
* Patients with female age at 1st OR in the study \<40 year;
* Patients with BMI ≤32;
* Patients with written informed consent;

Exclusion Criteria:

-
A Study of Neoadjuvant Nivolumab + Palbociclib + Anastrozole in Post-Menopausal Women and Men With Primary Breast Cancer

A randomized multi-arm study evaluating the safety and efficacy of palbociclib and anastrozole with or without nivolumab in participants with ER+/HER2- breast cancer


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

* Participants must have untreated, unilateral, histologically confirmed ER+, HER2- invasive breast cancer with primary tumor ≥2 cm in largest diameter (cT1-3) in one dimension by clinical or radiographic exam, for whom neoadjuvant endocrine monotherapy deemed to be a suitable therapy.
* Participants must be deemed eligible for surgery and must agree to undergo surgery after completion of neoadjuvant therapy and agree to provide tumor tissue at baseline, on-treatment, and at surgery.
* Women must have documented proof that they are not of childbearing potential.
* Participants must have a performance status (PS) ≤ 1 on the Eastern Cooperative Oncology Group (ECOG) scale

Exclusion Criteria:

* Participants who may have had any treatment, including radiotherapy, chemotherapy, and/or targeted therapy administered for the currently diagnosed breast cancer prior to enrollment or for whom upfront chemotherapy is clinically judged appropriate as optimal neoadjuvant treatment.
* Participants who have a history of or active, known or suspected autoimmune disease, or other syndrome that requires systemic steroids above physiological replacement dose or autoimmune agents for the past 2 years.
* Prior treatment with either ET or CDK4/6 inhibitors for Breast Cancer (BC) within 5 years or an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways, or history of allergy, or hypersensitivity to study drug components
* Prior malignancy active within the previous 3 years or participants with serious or uncontrolled medical disorders.
* Personal history of any of the following conditions: syncope of either unexplained or cardiovascular etiology, ventricular arrhythmia (including but not limited to ventricular tachycardia and ventricular fibrillation), long or short QT syndrome, Brugada syndrome, or known history of corrected QT prolongation, Torsade de Pointes, or sudden cardiac arrest.

Other protocol-defined inclusion/exclusion criteria apply.
Conventional vs Mindfulness Intervention in Parents of Children With Disabilities

This application compares the effectiveness of a conventional Parent Group intervention to Mindfulness- Based Stress Reduction (MBSR) in parents of children with autism spectrum disorders (ASD) and other disabilities. Parent groups are widely-used to provide information, emotional support, education and advocacy. MBSR is efficacious for people with medical, psychiatric or other concerns, and teaches stress reduction through mindfulness training and practice. In contrast to conventional parent groups, the investigators' studies suggest that mindfulness-based interventions may be particularly effective in reducing stress and improving the health and mental health of parents of children with disabilities. The investigators will assess parent factors that may correlate with intervention efficacy in the 2 treatment arms.

Specific Aim 1. To compare the effectiveness of Parent Groups versus MBSR interventions in parents of children with ASD or other developmental disabilities.

Hypothesis 1: Mothers and fathers in both treatment groups will show reduced stress, depression, and anxiety, and increased life satisfaction, health, and well-being. Treatment effects will be more pronounced in MBSR, including more normalized diurnal cortisol patterns.

Hypothesis 2: Improved parental outcomes will persist after treatment, and relate to booster session attendance, and/or the frequency that parents practice techniques learned in each treatment. Improvements will be sustained longer in the MBSR treatment. Parental benefits will impact families, and may be associated with improved child behaviors or less family conflict.

Hypothesis 3. The composition of intervention groups in Year 2 will be adjusted based on Year 1 data, and may reflect continued separation or integration of ASD vs other disability groups, or new combinations of participants.

Specific Aim 2: To identify aspects of maternal, family or child functioning that help explain variability in responses to Parent Group or MBSR interventions.

Hypothesis 4: Mothers or fathers with relatively more stress, health or mental health problems, will show more robust treatment responses. Variability in treatment responses may be associated with child age, maternal age, family ethnicity, and child behavior problems.

Hypothesis 5. Outcomes may relate to factors in the interventionists, greater treatment responses will be found when parents are matched with peer-mentors of the same gender, ethnicity, and child diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* parent of a child with a known developmental disorder
* parent of a child with a chronic medical condition with known lifelong physical and mental effects, e.g., childhood cancer, cystic fibrosis, and muscular dystrophy

Exclusion Criteria:

* those who are not parent of a child with a known developmental disorder or medical condition
Effects of Teduglutide on Cardiac Repolarisation and Conduction in Healthy Male and Female Volunteers

The primary objective of this trial is to investigate if teduglutide has an effect on cardiac repolarisation (QT, QTc interval). Secondary objectives are the investigation of possible effects on heart rate and cardiac conduction (RR and PR intervals, QRS duration), pharmacokinetics and safety and tolerability in healthy subjects, and to determine the effect of the positive control, moxifloxacin, for sensitivity analysis. The trial will consist of a screening and a treatment phase of four treatment periods. There is a washout period of at least 7 days and 4 weeks at maximum between administrations. The expected total trial duration for the individual subject will be about 7 weeks (maximum 17) weeks.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female volunteers
* Normal body weight (body mass index within ≥18 and 29 kg/m2 (inclusive) and a body weight \>50 kg (females) and \>60 kg (males).
Real-life Assessment of Brexpiprazole (Rexulti) in Schizophrenia and in Depressive Disorders

Not only being the mainstay of treatment for schizophrenia spectrum psychotic disorders, antipsychotics, especially the second-generation antipsychotics (SGAs) have also been recommended as augmenting agents for treating depression. Dopaminergic agents, including both dopamine D2/D3 antagonists and dopamine partial D2 agonists, have been effective for treating psychosis and schizophrenia. Amongst all SGAs, those with partial D2 agonistic property are generally acknowledged to have better side-effect profiles with lower incidence of extrapyramidal side-effects, prolactin increase, weight gain, QTc prolongation, and metabolic syndrome, as well as more efficacious in alleviating depressive symptoms. Up-to-date, three SGAs, namely aripiprazole, brexpiprazole and cariprazine, are known to possess such partial D2 agonism. ReSD-HK study is part of the ReSD Asian Study aiming to carefully evaluate a cohort of patients prescribed with brexpiprazole on its efficacy and tolerability as treatment for schizophrenia and/or depression in a real-life clinical setting.

This is a 6-month, non-interventional, prospective naturalist study that adult patients (18-65 years old) receiving brexpiprazole for treatment of psychosis and/or as adjunctive treatment for major depressive disorder are eligible to participate. Minimal exclusion criteria are employed to fit the usual real-life setting.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18- 65 years old at the time of enrollment
* Able to read and communicate in English and/or Chinese
* Able to give informed consent
* Has been diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5), or International Statistical Classification of Diseases and Related Health Problems 10th revision (ICD-10) to have either Psychotic Disorders (F10-F19.5, F20-23, F25, F32-F33)
* is receiving brexpiprazole as treatment for less than 4 weeks at the time of recruitment

Exclusion Criteria:

* Age \<18 years old
* Unable to read English or Chinese
* Unable to give informed consent
* Had been diagnosed to have Intellectual Disabilities (DSM-5) or Mental Retardation (ICD-10 F70-73)
Diagnosis of Cow's Milk Protein Allergy Among Infants and Children in Assuit University Children Hospital

The study will assess the diagnosis of Cow's milk protein allergy (CMPA) among infant and children in Assiut University Children Hospital using skin prick test and specific serum IgE

Food allergy is a reproducible specific immune response to the exposure to a given food. Cow's milk protein allergy (CMPA) is a clinically abnormal reaction to cow's milk protein (CMP) via immune mechanisms triggered by milk protein (Boyce etal., 2010) .

According to the European Academy for Allergy and Clinical Immunology (EAACI) and the World Allergy Organization (WAO), a hypersensitivity reaction to cow's milk involving the immune system can be called as CMPA.There is difference between CMPA and non-allergic cow's milk intolerance (e.glactose intolerance) which occurs as a result of lactase deficiency without involvement of the immune system (Venter etal ., 2013) .

CMPA is categorized into immunoglobulin IgE mediated, non-IgE mediated, or mixed CMPA(Sichereretal ., 2001) .

1.9% to 4.9% prevalence of CMPA among children with a peak in prevalence (2-3%) in the first year of life and prevalence of \<1% in children aged ≥6 years(Koletzkoetal ., 2012) .

Eligibility Criteria:
Inclusion Criteria:

1. age : from first day of life - 2 years
2. exclusively breast feeding,breast-fed infants with supplementary foods and non-breast-fed infants with supplementary foods who complain from either frequentregurgitation,vomiting,diarrhea,constipation)with/without perianal rash),bloodin stool or pallor.

Exclusion Criteria:

* Infant and child with gastrointestinal symptoms due to specific aetiology .
Pediatrics Owning Performance Study

A more convenient blood glucose monitoring system integrated with a responsive mobile health app may facilitate improved diabetes control in adolescent and young adult patients with Type 1 diabetes. The primary aim of this study is to determine if the POPS diabetes management system can improve diabetes control in the adolescent and young adult population. The investigators hypothesize that use of the POPS diabetes management device and mobile application (app) will be associated with lower HbA1C after 6-months of use in adolescent and young adult T1D patients.

This is a prospective, single-arm, single-subject clinical trial to study outcomes related to device use in the pediatric diabetes population. Patients will be recruited at the Children's Minnesota McNeely Diabetes Clinic and satellite clinics during routine office visits over a 6-month period until recruitment goals are met. Enrolled subjects will be given a POPS! Device (meter, lancet/test strips, and software app) to use for 6 months with periodic check-ins and follow-ups. Primary outcome, HbA1c, will be measured at baseline and 6-month follow-up. Secondary aims include assessment of blood glucose testing frequency and quality of life scores following 6-months of device and app use. The investigators will also describe sustained use over the study period, average blood glucose and variability, and frequency of hypoglycemic events (blood glucose \<70). Historical data for each patient will also be recorded from medical records, with each patient serving as their own comparative control.

Eligibility Criteria:
Inclusion Criteria:

1. Type 1 diabetes, diagnosed at least 6 months prior to enrollment
2. Aged ≥10 years, ≤25 years
3. Daily insulin of any type, administered as multiple daily injections (MDI) for at least 90 days prior to enrollment
4. Latest HbA1c ≥8.0%, ≤10.5%
5. Average self-blood glucose measurement frequency ≥2 per day and ≤4.5 per day based on meter download spanning 28-day period prior to qualifying HbA1c measurement
6. User of iPhone 5 or above with iOS above 10.0
7. English-speaking
8. Patient must be willing to only use POPS device to check blood glucose for duration of study (except in case of technical failure or emergency)

Exclusion Criteria:

1. Continuous glucose monitor user at time of enrollment or considering CGM use in the next 6 months
2. Concurrent participation in another study that may influence results
3. On insulin pump at time of recruitment or considering pump use in the next 6 months
4. Inability to perform self-care behaviors due to co-morbidities such as mental health disorder, developmental delay, or other prohibitive physical condition (blindness, etc)
5. Participation in a diabetes clinical trial intervention in the 12 months prior to enrollment
Qualitative Study of Topical Mesalamine Adherence in Patients With Ulcerative Colitis(UC)

The purpose of this protocol is:

1. To quantify the prevalence of adherence to topical mesalamine in patients with UC
2. To describe the determinants of medication adherence in patients with UC prescribed topical mesalamine

Patient adherence with topical mesalamine is low. Behavioral and psycho-social barriers to topical mesalamine adherence exist in patients with UC. These factors can be identified using qualitative testing in order to develop and design appropriate behavioral interventions to reduce non-adherence.

The investigators will undertake an observational study of medication persistence in 100 patients in the BIDMC clinic, "Persistence Cohort". Persistence will be measured using 12-month pharmacy refill data. The investigators will also employ a qualitative research design with discrete choice modeling in two phases: Phase I - Initial Interviews with 10 patients and Phase II - Focus Groups (2) with 5 patients each.

Eligibility Criteria:
Inclusion Criteria:

* must have ulcerative colitis diagnosed by a doctor at least 1 month prior to study participation
* must be prescribed topical mesalamine (e.g. Rowasa enemas or Canasa suppositories) by a doctor
* must be receiving care at Beth Israel Deaconess Medical Center

Exclusion Criteria:

* no diagnosis of ulcerative colitis
* no prescription for topical mesalamine
* not receiving care at Beth Israel Deaconess Medical Center
The Effect of Vitamin D on Fertility

Objective: To examine the effect of vitamin D supplements on the pregnancy and clinical pregnancy rate in embryo transfer cycles.

Design: Experimental study with a pre- and post-test. Setting: In Vitro Fertilization Center Patients: Its sample consisted of 118 women, 58 in the experimental group and 60 in the control group.

Intervention(s): At the beginning of the infertility treatment, the experimental group took vitamin D supplements, and the control group did not. Vitamin D supplementation for infertile women includes regulation of a diet rich in vitamin D, educational and motivational interviews about insolation, and taking vitamin D orally.

Main Outcome Measure(s): 25(OH)D and beta HCG levels


Eligibility Criteria:
Inclusion Criteria:

* 18-45 years old
* literate in Turkish
* voluntary participation
* primarily infertile
* had undergone controlled ovarian hyperstimulation and had a fresh ET
* vitamin D levels lower than 30ng/mL before infertility treatment

Exclusion Criteria:

* patients with uncorrected congenital or acquired uterine anomalies
* bone, parathyroid gland, kidney and liver disorders
* use of anticonvulsants/antacid drugs
* taking dietary supplements contain vitamin D
* secondary infertility
A Retrospective Natural History Study of Patients With Lysosomal Acid Lipase Deficiency/Wolman Phenotype

This is a Natural History study to characterize key aspects of the clinical course of lysosomal acid lipase (LAL) deficiency/Wolman phenotype in patients.

The objective of this study is to characterize key aspects of the clinical course of LAL deficiency/Wolman phenotype in patients including, but not limited to, survival and growth parameters, to serve as a historical control to inform the evaluation and care of affected patients and to provide a reference for efficacy studies of enzyme replacement or other novel therapies.

Eligibility Criteria:
Inclusion Criteria:

* Deceased patients diagnosed with LAL deficiency/Wolman phenotype in 1985 or later provided they have required data points in their medical records.

Exclusion Criteria:

* Patients will be excluded from the study if the required data points for inclusion are not available.
* Living LAL deficiency/Wolman phenotype patients will be excluded