cyrilzakka/clinical-trials huggingface dataset:
Endoscopic Gastric Tubulization

Endoscopic gastric tubulization is currently proposed in the Digestive Surgery Department of the Nouvel Hôpital Civil, Strasbourg, France, to adult patients with morbid obesity. The procedure is performed using the CE marked endoscopic suture device Overstitch (Apollo Endosurgery, Austin, Tx. USA). It is standard practice since October 2016.

The objective of this study is to prospectively collect data of patients who underwent an endoscopic gastric tubulization, from last visit before procedure to 2 years after procedure. These data are usually collected during medical consultations and will enable the evaluation of weight loss, quality of life and comorbidities improvement, reproducibility and durability of the technique.

Gastric restriction is one of the fundamental principles of gastric bypass and gastric banding. Despite its advantages (long term weight loss, comorbidities related to obesity improvement...), bariatric surgery is risky. In fact, complications putting the patient into a life-threatening condition can occur. Endoscopic approaches are similar to current surgical methods but less invasive, safer and allow ambulatory care.

Nowadays, practitioners have the possibility to reduce stomach size by merging tissues through an endoscopic endoluminal suture approach without any incision. This leads to similar results (gastric restriction, weight loss, quality of life and comorbidities improvement) compared with standard surgical procedure while reducing the risk of complications.

One of the major benefit of this technique is its reversibility. A new surgical or endoscopic procedure is possible at a later stage.

Endoscopic gastric tubulization is currently proposed in the Digestive Surgery Department of the Nouvel Hôpital Civil, Strasbourg, France, to adult patients with morbid obesity. The procedure is performed using the CE marked endoscopic suture device Overstitch (Apollo Endosurgery, Austin, Tx. USA). It is standard practice since October 2016.

The objective of this study is to prospectively collect data of patients who underwent an endoscopic gastric tubulization, from last visit before procedure to 2 years after procedure. These data are usually collected during medical consultations and will enable the evaluation of weight loss, quality of life and comorbidities improvement, reproducibility and durability of the technique.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for an endoscopic gastric tubulization in the Nouvel Hôpital Civil, Strasbourg, France
Specified Drug-Use Survey on Vedolizumab for IV Infusion 300 mg [Crohn's Disease]

The purpose of this survey is to evaluate the long-term safety and effectiveness of vedolizumab for intravenous (IV) infusion 300 milligrams (mg) in Crohn's disease (CD) patients in the routine clinical setting.

The drug being tested in this survey is called vedolizumab for IV infusion 300 mg. This drug is being tested to treat patients who have CD.

This survey is an observational (non-interventional) study and will look at the long-term safety and effectiveness of vedolizumab for IV infusion 300 mg in the routine clinical setting. The planned number of observed patients will be approximately 300.

This multi-center observational trial will be conducted in Japan.

Eligibility Criteria:
Inclusion Criteria:

1. Have moderate or severe active CD
2. Have inadequate response to existing therapies

Exclusion Criteria:

Patients with any contraindication for vedolizumab
Plasma Biomarker in Amblyopia Patients

This prospective study aims to observe the predictive effect of peripheral blood plasma biomarker on the outcome of treatment in children with different types of amblyopia. We also investigated the mechanism of neuromodulation in the visual development of amblyopic children.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with amblyopia
* 3-12 years of age
* Able to tolerate amblyopia treatment
* Agree to be involved in this study and agree to have a follow up visit every 3 months.

Exclusion Criteria:

* Have previous treatment history before
* Have pathological ocular anomalies known to cause reduced visual acuity
* Have previous psychiatric, visual or neurological disorders
* Have eccentric fixation and/or abnormal retinal correspondence
* Have attention disorder and learning disability that cannot comprehend psychophysical test instructions given and/or consent for themselves
Myocarditis Registry for Children and Adolescents - MYKKE

MYKKE is a prospective multi-center registry for children and adolescents with myocarditis. The aim is to generate prospective multi-center data on epidemiology, diagnostics, and therapy of pediatric patients with myocarditis in order to enable evidence-based diagnostic and therapeutic approaches for this myocardial disease.

MYKKE is a long-term prospective registry providing a core platform for clinical research studies, which can be attached in a modular fashion. After a six-month pilot phase including 8 centers, the basic registry was opened in June 2014 to all hospitals in Germany treating patients with paediatric heart disease. While the scientific lead is with two study coordinators and a study group consisting of principal investigators from the collaborating centres ("MYKKE Investigators"), MYKKE is hosted and technically administered by the Competence Network for Congenital Heart Defects, which was initiated in 2003 by the Federal Ministry of Education and Research of the German government and is now part of the German Center for Cardiovascular Research (DZHK). Ethical approval was first obtained at the initiating centre (Deutsches Herzzentrum Berlin) and subsequently confirmed by local authorities of all collaborating centres.

The treating physicians enter basic data from patients enrolled at the study site via an online web interface to a central study database. For each patient, a specific patient identification number (PID) is generated based on name, first name and date of birth in order to store data in a pseudonymized fashion. As the PIDs are generated by a specific algorithm, data from the same patient are always linked to the same dataset even when data from different visits are entered by different institutions.

The web interface provides two different forms for each patient. The first form ("general sheet") is filled-in only at first presentation and consists of 12 items regarding disease and patient history, and initial symptoms of the disease. The second type of sheet ("current visit") can be generated once for each new patient visit and includes 52 items on characteristics of the current visit, current symptoms, diagnostic tests performed, confidence of the treating physician in the diagnosis on a subjective scale, left-ventricular function, therapy, complications, and follow-up care provider after discharge. Items primarily require yes/no responses via ticking respective boxes, allowing for completing each data sheet in \<5 minutes when all data are available.

Eligibility Criteria:
Inclusion Criteria:

* Admission or referral diagnosis of myocarditis
* Age \<18 years
* Written informed consent of the parents or legal guardians

Exclusion Criteria:

* Unwillingness to give consent
The Development and Effectiveness of Heart Failure Self-Health Management Application

Aims: To develop a smartphone application and investigate its effectiveness on patients with heart failure after using the "heart failure self-health management application.".

Abstract Aims: To develop a smartphone application and investigate its effectiveness on patients with heart failure after using the "heart failure self-health management application.".

Design: The single-group pre- and post-test experimental design was adopted. Methods: This study used convenience sampling and the one-group pretest and posttest design as the research methods and developed the "heart failure self-health management application" using the Google cloud database and Web App. The research period was from July 1 to December 31, 2019, a total of 36 patients diagnosed with heart failure during hospitalization completed the pretest and posttest. This App (1) provides text and video heart failure self-care knowledge content; (2) enables users to record and browse blood pressure, heart rate, and weight; and (3) provides the data from the Dutch Heart Failure Knowledge Scale and Technology Acceptance Model.

Keywords: heart failure; self-health management; application

Eligibility Criteria:
Inclusion Criteria:

* Heart failure

Exclusion Criteria:

* Health
Effects of HIIT in Tolerance to Exercise of Individuals With HF and Coexisting COPD

INTRODUCTION: The complexity of the pathophysiology of heterogeneous diseases such as heart failure and obstructive pulmonary disease causes a different approach to these diseases or with a view as much as a better understanding of the same situations, with which the clinical profile of patients who are associated with an association is. It is known that regular physical training promotes progressive improvements in exercise tolerance, in the pulmonary ventilation / perfusion ratio and in respiratory function by strengthening. OBJECTIVE: To compare the effects of high-intensity interval training and continuous aerobic exercise, with peripheral endothelial function, brain natriuretic peptide levels, maximum exercise tolerance, distribution of lung volumes and quality of life of patients with obstructive pulmonary disease associated with heart failure. METHODS: This is a clinical, controlled, randomized and blinded trial. Peripheral endothelial function, tolerance to maximum and submaximal exercise, distribution of lung volumes, quality of life, presence of symptoms of depression and perception of clinical change will be evaluated. EXPECTED RESULTS: Incorporate into the care of these patients, new effective therapeutic approaches, of low cost and with greater technical and scientific evidence.


Eligibility Criteria:
Inclusion Criteria:

* Sedentary individuals with Heart Failure of all etiologies;
* Diagnosed moderate and severe chronic obstructive pulmonary disease;
* Clinical stability;
* No change in the medication class within three months before the beginning of the research.

Exclusion Criteria:

* Unstable angina;
* Myocardial infarction;
* Previous cardiac surgery up to three months before the beginning of the study;
* Hemodynamic instability;
* Orthopedic and neurological diseases;
* Psychological and/or mental impairment.
Prevention of Surgical Site Infections: Effectiveness of Nasal Povidone-Iodine and Nasal Mupirocin

We hypothesize the application of mupirocin or povidone-iodine to the nares is equally effective in short term Staphylococcus aureus(SA)suppression. Our overall study objective is to measure the rate of deep and superficial Surgical Site Infections (SSIs) after primary hip, knee, shoulder and elbow arthroplasty surgery and primary spinal fusion surgery requiring implantation of prosthetic material, when the patient receives either nasal mupirocin or nasal povidone-iodine prior to surgery.

Secondary study objectives include:

1. Measure hospital length of stay and re-admission rates in the mupirocin and povidone-iodine groups.
2. Measure adverse events related to mupirocin and povidone-iodine.
3. Measure rate of SA resistance to mupirocin.

We hypothesize the application of mupirocin or povidone-iodine to the nares is equally effective in short term Staphylococcus aureus(SA)suppression. Our overall study objective is to measure the rate of deep and superficial Surgical Site Infections (SSIs) after primary hip, knee, shoulder and elbow arthroplasty surgery and primary spinal fusion surgery requiring implantation of prosthetic material, when the patient receives either nasal mupirocin or nasal povidone-iodine prior to surgery.

Eligibility Criteria:
Inclusion Criteria:

* Primary arthroplasty or spinal fusion surgery
* Age greater than 18 years

Exclusion Criteria:

* Revision arthroplasty
* Revision spinal fusion surgery
* Primary spine surgery without implantation of prosthetic material
* Allergy to mupirocin
* Allergy to povidone-iodine
* Pregnancy
* Breastfeeding
5D LB Ultrasound in Determination of Fetal Weight in Normal Pregnancy : A Pilot Study

5D and 2D ultrasound will be done to normal pregnant women between 37 to 42 weeks gestation and fetal weight will be estimated using the hadlock formula using biometry measured by both ultrasounds. Accuracy of 5D ultrasound in determining fetal weight will be determined.


Eligibility Criteria:
Inclusion Criteria:

* 20-40years
* singleton pregnancy
* normal pregnancy

Exclusion Criteria:

* Intrauterine fetal death
* multiple pregnancy
* congenital anomaly
* nonvisualized fetal parts by ultrasound
* maternal medical disorders like diabetes and hypertension
Hip-Flexion Strength Training: Can Elastic Bands Induce a Relevant Effect?

Strength training of the hip flexors using elastic bands can induce an effect on isometric hip strength of at least 15 %.


Eligibility Criteria:
Inclusion Criteria:

* Physically active (more than 2.5 h/week) individuals

Exclusion Criteria:

* Injury in the lower back or legs within the last 6 months.
* Systematic strength training of the hip flexors more than once a week within the last 6 months before the study was initiated.
Improving Chronic Nocturnal Noninvasive Ventilation: a Multimodality Approach

The aim of the data collection is to create an advanced reliable method to remotely monitor patient on chronic home non-invasive ventilation (NIV), both regarding ventilatory efficacy and patient comfort, both in the hospital and at home by assessing gas exchange, lung mechanics and the interaction between the patient and the ventilator.

For this purpose, we will set-up of databank of synchronously acquired datasets of already standard care monitored parameters during NIV (transcutaneous monitoring of gas exchange; ventilator data including data on PVA), and newly non-invasively acquired data on patient effort (EMG, patient ratings) and lung (hyper)inflation (EIT), during the set-up and follow-up of standard care chronic NIV.

Can be provided on request as the registry rules are no in Dutch

Eligibility Criteria:
Inclusion Criteria:

* COPD patients indicated for chronic home NIV

Exclusion Criteria:

* not able to read the written information and/or sign the informed consent form
* no possibility to perfrom measurements at home
Influence of Transmission Season on Outcome of Treatment of Schistosoma Haematobium Infection in Mozambique

To assess the influence of seasonal variations in Schistosoma haematobium transmission on treatment outcome (morbidity and re-infection)

General objective To provide knowledge about the influence of transmission season (high and low) on the outcome of treatment assessed by cure rate, re-infection rate, regression and reappearance of urinary tract morbidity rate after treatment in order to optimise praziquantel treatment strategies for morbidity control in urinary schistosomiasis.

Specific objectives To determine the prevalence and intensity of Schistosoma haematobium infection before chemotherapy and compare cure rates and levels of re-infection after chemotherapy administered during high and low transmission seasons.

To assess urinary tract morbidity due to Schistosoma haematobium by ultrasonography and compare the regression and reappearance of urinary tract pathology chemotherapy administered during high and low transmission seasons.

To correlate morbidity determined by ultrasound with infection and morbidity parameters such as intensity of infection, micro- and macrohematuria, circulating cathodic antigen (CCA) in urine, proteinuria and leucocyturia and determine sensitivity, specificity and positive predictive values in relation to urinary tract morbidity.

Study design The main research question concerning the influence of transmission season on treatment outcome will be addressed in a consecutive cohort study with two separate but comparable cohorts. The first cohort will be examined and treated with praziquantel during the season with high transmission, February/Mach (group A) and the second cohort will be examined and treated during the low transmission season, in July approximately 5 months later (group B). Each cohort will be examined before treatment and 2, 6 and 18 months after treatment.

The study will be carried out in 4 primary schools; two from Machava J area and two from Costa do Sol area. The schools will be selected based on the following criteria: similar prevalence (\> 50%) and intensity of S. haematobium infection; absence or very low levels of S. mansoni infection; a minimum of 2 classes (\>35 pupils per class) at each level (3rd and 4th level) and similar distribution of boys and girls.Examinations will include urine for parasitology and haematuria and ultrasonography of upper and lower urinary tract

Eligibility Criteria:
Inclusion Criteria:

* children aged 8-12 years

Exclusion Criteria:

* All children presenting with macro-haematuria or severe pathology detected by ultrasonography (large masses, pseudo-polyps or hydronephrosis/hydroureter) at the 6 months follow-up examination will be treated with praziquantel and excluded in the data analysis.
Impact of Naloxone on the Analgesic Effect of Paracetamol in Healthy Volunteers

The aim of this study is to check if Naloxone induce an inhibiting effect on the analgesic effect of paracetamol in healthy volunteer, using evoked potentials.

Double Blind, cross-over study in healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men
* between 18 and 40 years old
* written consent given

Exclusion Criteria:

* Naloxone or paracetamol hypersensibility
* Excessive consumption of alcohol, tobacco, coffee, tea or toxicomania
* Concomitant medication
DRug Use and Infections in Hai Phong ViEtnam Among Persons Who Inject Drugs

The overarching purpose of the proposed research is to demonstrate that high coverage implementation of combined prevention and care using an innovative approach will end the HIV epidemic among PWID in Haiphong, Viet Nam.

Injection drug use is driving HIV epidemics in low/middle-income countries in Eastern Europe, Central Asia and Southeast Asia. "Combined prevention and care", including needle/syringe programs (NSP), medication-assisted treatment for opiate dependence, and antiretroviral treatment, has greatly reduced HIV incidence among persons who inject drugs (PWID) in many high-income areas, to where the "HIV epidemics" among PWID have "ended." There is now the need for a convincing demonstration that an HIV epidemic can be ended in a low/middle income setting. The overarching purpose of the proposed research is to demonstrate that high coverage implementation of combined prevention and care using an innovative approach will end the HIV epidemic among PWID in Haiphong, Viet Nam. The researchers define "ending the epidemic" as reducing HIV incidence to 0.5/100 person-years at risk.

Data collection will include recruitment using repeated community based respondent driven sampling (RDS) surveys, once per year among PWID in Hai Phong. Participants will be given a quantitative questionnaire and tested for HIV and Hepatitis C (HCV). Peer support groups will be mobilized to help recruit PWID and assist in educations on the benefits of early ART, access to methadone, antiretroviral treatment and psychiatric services, and ways to prevent HIV and HCV transmission through safe injection practices and safe sex. Additionally, the investigators will develop large cohorts of HIV positive and HIV negative PWID to closely document behaviors trends, HIV incidence, and the obstacles of the access and retention in HIV care and methadone. It has been shown that it is possible to end HIV epidemics among PWID in several high income countries. This study will build upon the knowledge and results gained in high income settings to achieve viral suppression among HIV positive PWID and reduce HIV/HCV incidence in order to "end the HIV epidemic" among persons who inject drugs in Haiphong.

Eligibility Criteria:
Inclusion Criteria:

* age 18 or older
* capable of giving informed consent and participating in study activities
* history of drug injection (confirmed by visual inspection or subject knowledge of injecting procedures)
* currently using an injectable drug (heroin or methamphetamine
* confirmed by urine test), not on MMT at initial recruitment
* willingness to participate in follow up studies, and expecting to remain in Haiphong for 2 years

Exclusion Criteria:

* less than 18 years of age
* on MMT at initial recruitment
* refusal to participate in follow-up studies
* no history of drug injection
* not currently using injectable drug (heroin or methamphetamine)
* not capable of giving informed consent
* those not expecting to remain in Haiphong for at least 2 years
Diet, Exercise and Vitamin D in Breast Cancer Recurrence

The purpose of this study is to reduce breast cancer recurrence and hence increase disease-free survival through a lifestyle program that includes a low glycemic diet, physical activity and vitamin D supplementation in women with breast cancer living in a Mediterranean country.

The aim of this study is to reduce breast cancer recurrence and hence increase disease-free survival through either a high intensity or a lower intensity lifestyle program that includes low glycemic index diet, physical activity and supplementation with vitamin D, for 33 months, in women living in Italy who have been surgically treated for breast cancer (either late stage or early stage but highly proliferative) within the previous 12 months. The objectives of the study are: to determine if the high intensity program is more efficacious than the lower intensity program in: 1) reducing breast cancer recurrence and 2) improving glycemic, hormonal, cardiovascular and cancer-related epigenetic markers.

Eligibility Criteria:
Inclusion Criteria:

1. Women with primary diagnosis of histologically confirmed breast cancer (T1 with Ki67≥30%, T2, T3 without metastasis) within 12 months from diagnosis.
2. Age ≥ 30 and \< 75 years.
3. Patients who are able to comprehend and are willing to sign the consent form and are able to adhere to the protocol including scheduled clinic visits and assigned treatment.

Exclusion Criteria:

1. Patients who do not possess the inclusion criteria for this study.
2. Patients with sarcoidosis or other granulomatous diseases or with hypercalcemia (Ca\>11mg/dL).
3. Patients with any previous or current concomitant other malignant cancer.
4. Pregnant or lactating women.
5. Patients with AIDS diagnosis
6. Patients with severe renal insufficiency
7. Patients with kidney stones (nephrocalcinosis or nephrolithiasis)
8. Patients participating in other lifestyle clinical trials