cyrilzakka/clinical-trials huggingface dataset:
Molecular Aspects of Preimplantation Genetic Diagnosis for NF1

Neurofibromatosis 1 (NF1) is a multisystem disorders characterized by skin abnormalities, such as café-au-lait spots and neurofibromas, learning disabilities, skeletal anomalies and vascular complications. Experience learns that this disorder is a great burden for patients. NF1 is an autosomal dominant disorder with 50% risk of transmission. The penetrance is nearly 100%, but the expression varies greatly even within families, which makes it nearly impossible to predict severity in offspring. Preimplantation genetic diagnosis (PGD) is a reproductive option for couples at risk of transmitting NF1 to their offspring. We perform a retrospective and observational multicentric study in the Maastricht University Medical Center, the University Hospital of Brussel and Strasbourg University Hospital. Our specific (and first) goal is to evaluate the molecular aspects of PGD for NF1 in an international cohort of couples requesting PGD for NF1.

About 50% of the patients with NF1 have a de novo mutation that can complicate development of a PGD test. Earlier studies from 1990 and 1992 have shown that de novo NF1 mutations usually occur on the paternal allele. We want to confirm these findings with collected data from our cohort. The high incidence of de novo mutations results in a higher chance of finding mosaicism in patients or their parents. As a result of this, it can become apparent during PGD test preparation that PGD treatment is no longer possible or indicated. The investigators will evaluate these aspects of PGD for NF1 in our cohort.

They are also interested, as a second goal, in other aspects of PGD treatment for NF1, such as the success rate in thier cohort. They expect the success rate to be the same as for other autosomal dominant disorders


Eligibility Criteria:
Inclusion criteria:

* Major subjects (≥18 years old)
* Couples who have been treated at the HUS for a preimplantation diagnosis request for type 1 neurofibromatosis (confirmed by a molecular molecular analysis) and who have benefited from preliminary analyzes, between 01/01/2004 and 30/06 / 2021
* Couple who, after receiving information, did not express their opposition to the reuse of their data for the purposes of this research

Exclusion criteria:

* Couples who expressed their opposition to participating in the study
* Subject under guardianship, curatorship or safeguard of justice
Children Education and Cardiovascular Risk Reduction in Their Parents

This study aims to evaluate if a multidisciplinary educational program in primary cardiovascular prevention for children could improve the Framingham Score index of their parents after one year.

Students aging 6 to 10 years old were exposed to two different approaches in the city of Sao Paulo, Brazil. For the students of the morning period (control group) we delivered written educational material for their parents in the beginning and middle of the year 2010 about healthy lifestyle (nutrition, exercise and smoke quitting). The students of the afternoon period (intervention group) received the same educational material for their parents and the children were exposed to a weekly educational program in cardiovascular prevention with a multidisciplinary heath team during the year 2010. This intervention tried to teach to these children, in different manners appropriate for their age, concepts of healthy nutrition, avoidance of tobacco and physical activity. Both at the inclusion in the study and one year later we collect data of parents and their children of the two groups, in a single weekend, including nutritional and exercise survey, measures of weigh, height, waist circumference, arterial blood pressure, and laboratorial exams.

Eligibility Criteria:
Inclusion Criteria:

* students aged 6 to 10 years old and their parents of a single private school of the city of Sap Paulo, Brazil

Exclusion Criteria:

* children and/or parents that do not agree to participate of the study;
* children and/or parents that are taking immunosupressive drugs;
* parents with known atherosclerotic disease such as angina or myocardial infaction, stroke, and/or peripheral arterial disease;
* parents with untreated hypothyroidism, untreated hypopituitarosm, nefrotic syndrome, chronic renal failure, congenital biliary allof, storage diseases, lupus and/oracquired immunodeficiency syndrome.
Nudging for Vaccination : Efficacity and Acceptability Among Medical Students

Nudge is a set of methods aimed at helping people adopt a behavior by a gentle prompt, conscious or not. Classically, Nudges rely on heuristics and cognitive biases. These methods have been studied for years in social psychology and are receiving renewed attention since the awarding of the Nobel Prize in economics to Richard Thaler for his work on the application of Nudge to the economy.

Health professionals are very inadequately vaccinated (25 to 45% of the population). Some studies have shown that a Nudge based on intent implementation can significantly increase vaccination coverage. However, few studies evaluate the acceptability of Nudge or its application to health professionals.

The investigators sought to apply a Nudge based on availability heuristics to health professionals, in order to evaluate its effectiveness and terms of behavior adoption (influenza vaccination) and its acceptability.

The investigator's hypothesis is that Nudging is both effective and acceptable and that people found nudging more acceptable if they have been exposed to a nudge.

The investigators asked residents in general medicine to pass a questionnaire including a Nudge. This Nudge was the influenza vaccine prescription form accompanied on the back of the telephone numbers of the occupational health centers of the hospitals where residents were on probation.

The interns of the group "Nudge" saw at the end of their questionnaire the following statement: "If you are not vaccinated against the flu so far, you can get the form stapled to this questionnaire, it will allow you to get the vaccine in pharmacy. On the back you will also find practical information about immunization services at your place of training. " A group will receive an implemented Nudge questionnaire, a group will receive a questionnaire without Nudge and a control group will not be asked. (Phase 1) The 3 groups will receive a month later a questionnaire evaluating the effectiveness in terms of immunization coverage, and the acceptability of the Nudge, for oneself and for others. (Phase 2) The control group will only receive the Phase 2 questionnaire to control the Hawthorne effect.

The difference between the 3 groups will consist exclusively in the exposure of the participants to:

* A questionnaire on their attitude (opinion) towards vaccination;
* The numbers of the occupational health vaccination centers of their places of training;
* The flu vaccine prescription form, to be signed and stamped by a doctor (also already freely available on the internet)

Eligibility Criteria:
Inclusion Criteria:

* medical students

Exclusion Criteria:

* none
Neuro 1 vs. Neuro 2 Sound Processors

This study evaluates the benefit of Neuro 1 sound processor upgrade in speech perfomance in adults. Half of participants will be tested with Neuro 1 first and Neuro 2, while the other half will be tested with Neuro 2 first and then Neuro 1.

The Neuro 1 processor represented a technological advancement over past models, particularly in detecting the environment and automatically adjusting to the sound environment. A second version of the Neuro 1 processor has been developed, the Neuro 2. The signal processing and stimulation characteristics are similar, so speech comprehension levels are expected to be equivalent. This study is designed to compare Neuro 1 and Neuro 2 in terms of audiometric performance.

Eligibility Criteria:
Inclusion Criteria:

* written informed consent
* primary implantation
* subject having participated to previous Neuro 1 sound processor study in Canada
* fluent in English, including reading and writing.

Exclusion Criteria:

* psychologically unsuitable
* unrealistic expectations regarding possible benefits, risks, and limitations that are inherent to the device
* non compliant with all investigational requirements.
Study of MDX-010 in Patients With Metastatic Hormone-Refractory Prostate Cancer

Multicenter study in which patients with metastatic hormone refractory prostate cancer (HRPC), who have not had previous chemotherapy or immunotherapy treatments, received MDX-010 every 3 weeks for 4 doses (12 weeks total duration of induction). MDX-010 was administered at escalating dosage levels of 3, 5, and 10 mg/kg/dose infusions. At least 6 patients were to be enrolled in each dosage level. Patients who tolerated and responded to treatment or who had stable disease for 3 months or longer and who subsequently progressed during the follow up phase of the study had the option to receive additional treatment with MDX-010, up to 4 cycles. Patients were followed in the study for response up to 2 years and were followed for survival status for up to 5 years after enrollment.


Eligibility Criteria:
Inclusion Criteria:

* Histologic diagnosis of adenocarcinoma of the prostate
* Metastatic prostate cancer (positive bone scan or measurable disease)
* Total testosterone of less than 50 ng/dL, except for patients with prior orchiectomy, where testosterone does not need to be measured.
* Patients who are receiving an antiandrogen as part of primary androgen ablation must demonstrate disease progression following discontinuation of antiandrogen and completion of a washout period and then observe disease progression.
* Patients must stop using any herbal product known to decrease PSA levels (eg., saw palmetto and PC-SPES) or any systemic or topical corticosteroid at least 4 weeks prior to screening. Progressive disease must be documented after discontinuation of these products.
* Progressive disease after androgen deprivation (or hormone therapy). For patients with measurable disease, progression will be defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. For patients with progression in, or without any measurable disease, a positive bone scan and elevated PSA will be required.
* Patients receiving bisphosphate therapy must have been on stable doses for at least 4 weeks with stable symptoms prior to enrollment.
* No prior chemotherapy or immunotherapy (tumor vaccine, cytokine, or growth factor given to control prostate cancer).
* Prior radiation therapy completed at least 4 weeks prior to enrollment. No prior radiopharmaceuticals (strontium, samarium) within 8 weeks prior to enrollment.

Exclusion Criteria:

* Bone pain due to metastatic bone disease severe enough to require routine narcotic analgesic use.
* History of severe hypersensitivity reactions to drugs formulated with polysorbate 80.
* Patients with active autoimmune disease or a history of autoimmune disease that required systemic steroids or immunosuppressive medications, except for patients with vitiligo.
* Prior therapy with any anti-cytotoxic T-lymphocyte antigen 4 (anti-CTLA-4) antibody.
* Active infection requiring therapy.
* Concurrent medical condition requiring the use of systemic or topical corticosteroids; systemic or topical corticosteroids must be discontinued at least 4 weeks prior to enrollment. The use of inhaled corticosteroids is acceptable.
Transient Electrocardiogram Assessment in Stroke Evaluation

In stroke survivors, atrial fibrillation is typically detected with short-term electrocardiogram (ECG) monitoring in the stroke unit. Prolonged continuous ECG monitoring is impractical and requires substantial resources while insertable cardiac monitors are invasive and costly. Chest and thumb-ECG could provide an alternative for atrial fibrillation detection post-stroke.

The primary objective of our study is to assess the incidence of newly diagnosed atrial fibrillation during 28 days of chest and thumb-ECG monitoring in patients with cryptogenic stroke. Secondary objectives are to assess Health-related Quality of Life using Short Form-36 and the feasibility of the Coala Heart Monitor in patients with stroke.

Stroke survivors in Region Gävleborg, Sweden, will be eligible for the study from October 2017. Patients with a history of ischemic stroke without documented atrial fibrillation before or during ECG evaluation in the stroke unit will be evaluated by the chest and thumb-ECG system Coala Heart Monitor. The monitoring system is connected to a smart phone application which allows for remote monitoring and prompt advice on clinical management. Over a period of 28 days, patients will be monitored twice daily and may activate the ECG recording at symptoms. Upon completion, the system is returned by mail. This system offers a possibility to evaluate the presence of atrial fibrillation post-stroke, but the feasibility of this system in patients who recently suffered from a stroke is unknown. In addition Health-related Quality of Life using Short Form-36 in comparison to Swedish population norms will be assessed. The feasibility of the Coala Heart Monitor will be assessed by a self-developed questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Patients, aged ≥18 years, with a validated diagnosis of ischemic cryptogenic stroke are eligible for the study.

Exclusion Criteria:

* For screening with chest and thumb-ECG, exclusion criteria are as follows: previously known atrial arrhythmia with an indication for anticoagulation, implantable defibrillator, pacemaker or insertable cardiac monitor, pregnancy, permanent indication for anticoagulation (including low-molecular weight heparin) due to atrial arrhythmia, mechanical heart valve, deep vein thrombosis, or pulmonary embolism. Patients with a life expectancy ≤6 months (e.g. severe heart failure New York Heart Association functional class IV or malignancy) are likewise excluded.
Oral Cancer Screening and Education in Hong Kong

This study will be conducted to obtain data on oral cancer risk factors to generate machine learning models with good predictive accuracy for stratifying individuals with high-oral cancer risk and delineating high-risk and low-risk oral lesions. Likewise, this study will seek to provide oral cancer-related health education and training on oral-self-examination for beneficiaries


Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals satisfying age and residential area criteria with no previous history of oral cancer. Individuals with a history of other cancers will be included in the study provided they have been in remission for more than three years.

Exclusion Criteria:

* Participants with reduced mouth opening (irrespective of the cause) to permit proper administration of VOE or photosensitive epilepsy will be excluded. Likewise, those who decline the provision of written consent or participation in any part of the study.
Sugarsquare. Focus on the Adolescent: Digital Treatment of Type 1 Diabetes Through the Internet

Background

The treatment of diabetes is multidisciplinary. Alignment of care of the various professional disciplines is, however, not always optimal. This can lead to confusion about treatment interventions and behavioral advices. In adolescence, good fine-tuned care is of extreme importance because of the difficulties in regulation of the disease in this phase of life (Snoek, 2004). These difficulties are due to biological changes but also to socio-psychological developmental changes. The adolescents' psychological development demands more autonomy and responsibility for the diabetes (care) by the adolescent. The social development can conflict with the treatment regime, because of the adolescents' social needs (ADA, 2001; Houdijk, 1998; Snoek, 2004). In this study the investigators assess whether an interactive website, on which adolescents with diabetes and their treatment team can communicate, leads to better alignment of care and better control over the disease.

Intervention

The diabetes has great impact on the adolescents' everyday life. Finding a balance between more autonomy, participating in social life with (healthy) peers and control of the disease is difficult and seems to act as a thread during this phase in life.

This can lead to questions and uncertainty at any given moment. The interactive website provides the adolescent access to information and to his or her individual treatment plan and advices fitted to his or her condition and life. The adolescent can pose questions at any given moment through the online forum and their personal treatment page. Since the treatment team answers the question within a day, fit between diabetes care and adolescents' everyday life is optimized.

Research question

Does an online interactive treatment environment, on which adolescents with diabetes can communicate with their treatment team, lead to better fit of care and to better disease control?


Eligibility Criteria:
Inclusion Criteria:

* adolescents aged 12 and older;
* diagnosed with diabetes mellitus;
* receiving regular outpatient hospital-delivered diabetes care provided by the Children's Diabetes Center Nijmegen (CDCN)

Exclusion Criteria:

* adolescents who were unable to read questionnaires because of language, or cognitive problems were excluded
Pegfilgrastim as Support to Pediatric Sarcoma Patients Receiving Chemotherapy

Physicians are conducting a clinical trial for patients with pediatric sarcoma. Sarcoma is a type of bone cancer that can be treated with chemotherapy which can affect the bone marrow, where blood cells are produced. Neutrophils are a type of white blood cells that fight infection and are produced in the bone marrow. If the neutrophil count becomes too low due to chemotherapy, a potentially serious condition called neutropenia occurs. Neutropenia is serious because it can affect the body's ability to protect against many types of infections. Pegfilgrastim is an investigational drug being evaluated for its potential ability to increase the number of neutrophils. The purpose of this study is to determine the safety and effectiveness of pegfilgrastim in preventing neutropenia following chemotherapy in pediatric patients up through the age of 21 with sarcoma.


Eligibility Criteria:
* Sarcoma \* No previous chemotherapy or radiotherapy \* Patients who will be receiving chemotherapy consisting of Vincristine, Doxorubicin, Cyclophosphamide, Etoposide, Ifosfamide, and Mesna
Efficacy of Vibrating Capsule in Patients With Chronic Constipation

Constipated patients in the participating center from February 2017 to June 2018 (anticipated) were prospectively enrolled. Number of defecation per week，Bristol score，and Colon transmission experiment were compared with the constipated patients before treatment.

Constipation affects the quality of life of patients, some patients abuse laxatives or repeated medical treatment, increased medical costs. At present, the main treatment of constipation is to adjust life style, medicine, psychotherapy, biofeedback and surgical treatment. However, the above methods are associated with adverse reactions, and the patient's satisfaction is still low. A new approach is needed to solve this clinical problem.

Investigators have developed a vibration capsule that can be adjusted in different modes.

Preliminary animal experiments showed that the capsule was safe and increased the number of defecation.

This study is a clinical research for patients with constipation, to explore the effect in different vibrating modes in patients with constipation and tract emptying transmission and its effectiveness.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged form 18 to 80
* Clinical diagnosis of functional constipation
* Must be able to swallow vibrating capsule

Exclusion Criteria:

* complex history of gastrointestinal diverticula, obstruction, ulcer, bleeding, stenosis or fistula.
* recent use of banned drugs.
* patients who are preparing for mri.
Roasted Pulse Snacks, Post-prandial Food Intake, Appetite, and Glycemia

An investigation on the effects of roasted pulse snacks on post-prandial glycemic and satiety response in healthy young adults.

An acute, randomized, controlled cross-over trial examining the post-prandial glycemic and satiety response to six snacks will be conducted. The study treatments are: 1) roasted corn nuts, 2) roasted chickpeas, 3) roasted yellow peas, 4) roasted pinto beans 5) roasted soybeans, and 6) roasted almonds. They will be matched for calorie content and provided in 200 kcal servings.

Eligibility Criteria:
Inclusion Criteria:

* BMI: ≥18.5 and ≤29.9 kg/m2
* Fasting serum glucose: ≤5.5 mmol/L

Exclusion Criteria:

* Fasting serum glucose \> 5.5 mmol/L
* Smoking
* Thyroid problems
* Previous history of cardiovascular disease, diabetes, liver or kidney disease, inflammatory bowel disease, celiac disease, short bowel syndrome, any malabsorptive syndrome, pancreatitis, gallbladder or biliary disease
* Presence of a gastrointestinal disorder or surgeries within the past year
* Consuming prescription or non-prescription drug, herbal or nutritional supplements known to affect blood glucose or that could affect the outcome of the study as per investigator's judgment
* Known to be pregnant or lactating
* Known intolerance, sensitivity or allergy to any ingredients in the study products.
* Extreme dietary habits (i.e. Atkins diet, very high protein diets, etc.)
* Uncontrolled hypertension (systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg)
* Weight gain or loss of at least 10lbs in previous three months
* Excessive alcohol intake
* Restrained Eaters (identified by Eating Habits Questionnaire)
Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation

The STEPCARE-trial is a 2x2x2 randomised trial studying patients who have been resuscitated from cardiac arrest and who are comatose. It will include three different interventions focusing on sedation targets, temperature targets and mean arterial pressure targets.

3500 patients who are comatose after cardiac arrest will be included in a trial studying three separate targets. All patients will be randomised to a control or an intervention arm for sedation, temperature and blood pressure targets. These are.

1. Continuous deep sedation for 36 hours or minimal sedation (SEDCARE)
2. Fever management with or without a feedback-controlled device (TEMPCARE)
3. A mean arterial pressure target of \>85mmHg or \>65mmHg. (MAPCARE)

Participants will be followed up at 30 days and 6 months. The primary outcome will be survival at 6 months.

Eligibility Criteria:
Inclusion Criteria:

1. Out-of-hospital cardiac arrest
2. Sustained ROSC - defined as 20 minutes with signs of circulation without the need for chest compressions
3. Unconsciousness defined as not being able to obey verbal commands (FOUR-score motor response of \<4) or being intubated and sedated because of agitation after sustained ROSC.
4. Eligible for intensive care without restrictions or limitations
5. Inclusion within 4 hours of ROSC

Exclusion Criteria:

1. On ECMO prior to randomization
2. Pregnancy
3. Suspected or confirmed intracranial hemorrhage
4. Previously randomized in the STEPCARE trial.