cyrilzakka/clinical-trials huggingface dataset:
Opsoclonus Myoclonus Syndrome/Dancing Eye Syndrome (OMS/DES) in Children With and Without Neuroblastoma (NBpos and NBneg)Opsoclonus Myoclonus Syndrome/Dancing Eye Syndrome (OMS/DES) in Children With and Without Neuroblastoma (NBpos and NBneg)

The OMS/DES study is a multinational European Trial for Children with the Opsoclonus Myoclonus Syndrome / Dancing Eye Syndrome.

This trial brought on the way by specialists of the EPNS (European Paediatric Neurology Society), the GPOH (Gesellschaft für Pädiatrische Hematologic und Oncologie) and the SIOPEN (SIOP (International Society Oncology Pediatric) Europe Neuroblastoma).

This protocol will investigate an escalating treatment schedule starting with a corticosteroid standard treatment with dexamethasone pulses (first step), which is followed, if response has been inadequate after 3 months of treatment, by the addition of CP (second step) and, if still no sufficient improvement, by the replacement of CP by Rituximab (third step). Treatment intensification is decided on the basis of standardized scoring of OMS/DES severity.


Eligibility Criteria:
Inclusion Criteria:

* Children with newly diagnosed OMS/DES either NB-pos or NB-neg.

Three out of the following four components are necessary for the diagnosis of OMS/DES:

* Opsoclonus or ocular flutter (but not nystagmus)
* Ataxia and/or myoclonus
* Behavioural change and/or sleep disturbance
* Neuroblastoma The diagnosis of OMS/DES may be difficult in some patients. Opsoclonus, in particular, may be intermittent or late in onset. A video example will be available at www.dancingeyes.org.uk. If uncertain, please contact the national coordinator for support in interpreting clinical features.

  * Age 6 months or over up to less than 8 years (\< 8th birthday) The date of diagnosis of OMS/DES is the date on which a doctor confirms the condition to be OMS/DES. The date of symptom onset needs also to be documented.
  * Treatment start with the standard corticosteroid treatment with dexamethasone pulses as proposed by the guidelines given in this trial protocol (see 11.10, page 71).
  * In patients with presumed NB-neg OMS/DES, neuroblastoma must be excluded according the guidelines of this trial (see chapter 4.4.1.4, page 30, and appendix 11.9, page 70)
  * Documented informed consent for treatment and enrolment in the trial by parents / legal representatives.

Exclusion Criteria:

•Patients with opsoclonus, myoclonus or ataxia caused by other identified disease (e.g. current active CNS infection, neurometabolic disorder or demyelination).

An identified viral precursor is not an exclusion criterion.

* prior or parallel use of chemotherapy (other than required for treatment of the neuroblastoma)
* Corticoid steroid for OMS/DES or other reasons lasting 14 days or more immediately before treatment start according the standard treatment proposed (treatment with corticosteroids for less than 14 days will be allowed)
* contre-indication of use of one of the experimental study drug (cf Summary of Product Characteristics used in this study)
Stepped Care for Weight Loss Maintenance

This study is a 3-group, parallel design, randomized controlled trial (RCT) in approximately 258 adults with obesity that will investigate whether a 16-week behavioral weight loss treatment and a 52-week stepped-care digital health intervention can improve the maintenance of a ≥ 5% weight loss.

16-week run-in (Phase 1). To qualify for randomization, participants must lose ≥ 5% of initial weight in the 16-week run-in. This loss will be achieved with the provision of weekly-group lifestyle counseling, which includes a partial meal replacement diet.

52-week randomized trial of 3 weight loss maintenance strategies (Phase 2): Participants who have achieved ≥ 5% weight loss during Phase 1 will be randomly assigned to 1 of 3 groups:

1. Participants in the Usual Care group will be emailed monthly educational modules with information on maintaining weight loss.
2. Participants in the SELF group will receive a wireless "smart" body weight scale and a wearable physical activity tracker, and daily text messages with tailored feedback to assist in weight loss maintenance.
3. Participants in the STEP group will be enrolled in an intervention that consists of 4 steps that are progressive and based on response to treatment. After 13 weeks at each step, participants who do not maintain a ≥5% weight loss or regain 2 percentage points of weight from the participants randomization value will move to a higher intensity step. Participants who maintain weight loss will stay at the same step.


Eligibility Criteria:
Inclusion Criteria:

* BMI\>/=30 kg/m2 or \>/=27 kg/m2 with an obesity-related complication
* Age 18-70 years
* Completion of baseline assessment tasks
* Ability to engage in physical activity
* Own a smartphone capable of receiving text-messages and syncing to weight scales and physical activity trackers
* Home wireless access

Exclusion Criteria:

* Serious medical condition or psychiatric condition that may pose a risk to the participant during intervention, cause a change in weight, or limit ability to adhere to the behavioral recommendations of the program
* Pregnant or planning pregnancy in the next 1.5 years
* Weight\>440 lbs
* Planned move out of the area in the next 1.5 years
* Recently began a course of or changed the dosage of medication that can cause significant change in weight
* History of bariatric surgery
* Weight loss of \>5% in the previous 6 months
* Household member already participating in study
Outcome of Old Patient With Articular With Articular Implant Infection

Articular Implant Infection (AII) is itself a complicated diagnosis and a challenging condition to treat. In elderly patients, the application of existing recommendations is impeded by multiple frailties For a better knowledge of the long-term consequences of AII in elderly patient, the investigators conduct a prospective, multicentric study, whitch aim this is to better evaluate the burden of AII on elderly patients, in terms of quality of life. Secondly, the investigators would like to identify the factors that influence the prognosis, in order to guide further prospective research.

Articular Implant Infection (AII) is itself a complicated diagnosis (diagnosis confirmation, pathogen identification, with appropriate samples) and a challenging condition to treat (long antibiotic exposure, repeated surgery, complex implant change). This condition requires a good cooperation between surgeon and infectious disease specialist, with a comprehension of each one's constraint. In elderly patients, the application of existing recommendations is impeded by multiple frailties (malnutrition, loss of autonomy, polypathology) which make each decision crucial. Indeed, from the choice of surgery to antibiotics management, all medical decision can induce more adverse events than in younger patients. For a better knowledge of the long-term consequences of AII in elderly patient, the investigators conduct a prospective, multicentric study, based on the evaluation of the EQ-5D-5L score during one year after AAI diagnosis in patients older than 75. The investigators evaluate this score and compare different groups of patients, according to age, nutrition status, Charlson comorbidity index, hospital stay length, and loss of autonomy, among others. The aim of this study is to better evaluate the burden of AII on elderly patients, in terms of quality of life. Secondly, the investigators would like to identify the factors that influence the prognosis, in order to guide further prospective research.

Eligibility Criteria:
Inclusion Criteria:

* hospitalized in infectious diseases, surgery, post-emergency unit, or geriatrics,
* diagnosed with a hip or knee prosthesis infection in the previous month according to the SPILF criteria (2009)(1).

Exclusion Criteria:

* Above criteria not met,
* Patient refusal,
* Mild cognitive impairment or more significant.
Labor Induction With Double Balloon Device, Oral Misoprostol and Concomitant Use of Both

The aim of this study is to compare the rate of cesarean delivery between 3 methods of labor induction: double balloon device, oral misoprostol and combination of the two.

Induction of labor is a common obstetrical procedure. It accounts for 20% of laboring women worldwide.

In the past, studies showed that cesarean delivery rates (CDR) are higher in women who are induced. These studies were comparing induction to spontaneous labor, which is not the management in practice, and when the comparison was made between induction and expectant management, the conclusion was that the induction does not increase CDR and can even reduce its' rate.

Failure of induction depends on the definition, and even among randomized controlled trials, this definition may vary greatly.

The decision whether to use a mechanical or pharmacological agent depends on Bishop score, parity, contraindications to one of the methods and patient-doctor preference.

Recently, more data are available regarding induction with oral misoprostol (OM) and this method is becoming more popular because OM is effective, safe, convenient, cheap and easy to administer.

If mechanical induction is preferable, either single or double balloon device (DBD) can be used. These methods have been previously studied and neither found to be superior.

A recent study showed that, insertion of the DBD for 6 hours in nulliparous women, results in shorter time to delivery (26 hours vs. 31.4 hours, p=0.015), similar Bishop score after removal ( 5.74 vs. 5.26, p=0.2) without increasing the rate of cesarean deliveries (19% vs 32%, p=0.135) when compared to insertion of the DBD for 12 hours as instructed by the manufacturer. Several studies have shown that a combination of pharmacological and single balloon device results in higher rates to achieve vaginal delivery when compared to each method separately

The investigators hypothesize that with the combination of DBD for 6 hours and OM we will be able to reduce the rate of cesarean deliveries when compared to each method separately.

To date, there are no studies that compared double balloon device with oral misoprostol used concomitantly.

Eligibility Criteria:
Inclusion Criteria:

* unfavourable cervix (Bishop score ≤ 4),
* indication for induction of labor (medical or obstetrical),
* 37 completed gestational weeks,
* vertex presentation,
* singleton pregnancy
* intact membranes.

Exclusion Criteria:

* previous cesarean delivery
* previous uterine surgery (eg: myomectomy)
* noncephalic presentation
* multiple pregnancy
* pre-eclampsia with severe features
* oligohydramnios (Maximal vertical pocket ≤2)
* estimated fetal weight \<10% percentile
* any contraindication to Vaginal delivery
Efficacy and Acceptability of Two Lubricant Eye Drops

Efficacy and acceptability of two new artificial tears following two weeks of treatment in patients with dry eye. Patients will be randomized to 1 of 2 treatments for 7 days then crossover to the alternate treatment for 7 days.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female
* At least 18 years of age
* Current use of artificial tears

Exclusion Criteria:

* Any uncontrolled systemic disease
* Pregnancy or planning a pregnancy
* Contact lens wear
Observational Study of Expected ARF Recovery

This is an observational cohort study of the association between patient expectations for functional recovery and quality of life among acute respiratory failure survivors 6 months after hospital discharge.

This study will enroll adults who are diagnosed with acute respiratory failure during an ICU admission and discharged from the ICU alive. All participants will receive usual clinical care. Participant expectations for functional recovery will be assessed before hospital discharge via a standardized questionnaire containing a visual analogue scale and questions about expected ability and importance of being able to perform activities of daily living and instrumental activities of daily living in 6 months. At 6 months, participants will be re-contacted by phone. Study staff will administer questionnaires to assess whether patient expectations have been met. Quality of life will be assessed using the WHOQOL-BREF and the EQ-5D-VAS.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Respiratory failure managed in the ICU, where respiratory failure is defined as ≥1 of the following:
* Mechanical ventilation via an endotracheal tube ≥ 24 hours OR
* Non-invasive ventilation (CPAP, BiPAP) ≥ 24 consecutive hours\* provided for acute respiratory failure (not for Obstructive Sleep Apnea or other stable use) OR
* High flow nasal cannula with FIO2 ≥ 0.5 and flow rate ≥ 30 LPM for ≥ 24 consecutive hours\*

  \*Occasional rest periods of ≤ 1 hour each are not deducted from the calculation of consecutive hours.
* Expected by the clinical team to be discharged home alive

Exclusion Criteria:

* Patient in ICU \< 24 hours
* Mechanical ventilation at baseline or mechanical ventilation solely for airway protection or obstruction
* Residing in a medical institution at the time of hospital admission
* Homeless / Prisoner / Primary residence not in the USA / Unable to communicate by telephone in English
* More than mild dementia (either known diagnosis of moderate or worse dementia or IQ-CODE \> 3.6; screening performed on patients \> 50 years old or with family reports of possible memory decline)
* Patient on hospice at or before time of enrollment
* Patients who, based solely on pre-existing medical problems (such as poorly controlled neoplasm or other end stage disease, including Stage IV heart failure or severe burns), would not be expected to survive 6 months in the absence of the acute respiratory failure.
* Patients with neurological injury either receiving treatment for intracranial hypertension or who are not expected to return to consciousness.
* Pregnancy
Cerebral Activation and Bilateral Stimulation by Cochlear Implantation in Bilateral Deaf Adults

The primary objective to this study is to describe bilateral auditory information processing in profoundly deaf patients with bilateral cochlear implants compared with normal hearing patients. Assumption used is that due to the central consequences of bilateral deafness on binaural auditory information central processing, time between activation of the two cochlear implants is a decisive factor in bilateral implantation compared to unilateral implantation


Eligibility Criteria:
Inclusion criteria for patients:

- profoundly deaf patients with bilateral cochlear implants

Exclusion criteria for patients:

* post-operative complications
* incomplete surgical insertion of one of the cochlear implant
* age under 18 years
* non-compliant patient
* pregnant woman or woman with no efficient contraception method
* informed consent not signed
* no health insurance

Inclusion criteria for control

- normal hearing subjects

Exclusion criteria control

* normal hearing subject
* subject under 18 years old
* unilateral or bilateral hearing loss
* non-compliant subject
* pregnant woman or woman with no efficient contraception method
* informed consent not signed
* no health insurance
Evaluating Tools for Health Promotion and Disease Prevention

The study will evaluate the effect of familial risk assessment and prevention prompts tailored to familial risk on health behaviors and use of preventive services among adults who are members of primary care practices in the U.S.

The purpose of this study is to evaluate the clinical utility of a new family history tool, Family Healthware™ by determining whether family history risk assessment and personalized prevention messages have any impact on health behaviors and use of medical services. The hypothesis to be tested is that patients who are provided with personalized prevention messages based on an assessment of their family history of disease will be more motivated to make behavior changes and use preventive health services than patients who do not have their family history assessed and who receive only generalized (not personalized) prevention messages. An additional hypothesis, tested when participants see their primary care physician during the study, is that providing a copy of the graphical family history, risk and prevention messages to the patient's physician will increase delivery of recommended preventive services (screening, referral, and health habit advice).

The study will consist of enrolling approximately 8360 patients aged 35-65 years who attend primary care practices that are part of research networks affiliated with the three research centers. The practices will be randomized into two groups. Patients in practices randomized to Group 1 will complete a pre-test and the family history tool, and will receive personalized prevention messages based on their level of familial risk and current risk behaviors. After six months, Group 1 patients will complete a post-test. Patients in Group 2 will complete the pre-test and receive standard prevention messages (appropriate for sex) about maintaining good health and preventing disease. After 6 months Group 2 patients will complete the post-test and the family history tool. The pre- and post-test will include assessment of risk factors, use of medical services (especially preventive services), interest in modifying health behaviors, risk perceptions, etc. The analysis will compare changes in health behaviors between patients in Groups 1 and 2 and will also examine differences by familial risk strata (average, moderate, high).

Eligibility Criteria:
Inclusion Criteria:

* member of participating primary care practice network
* able to provide informed consent
* able to complete data assessment tools in English

Exclusion Criteria:

* diagnosis of CHD, stroke, diabetes, breast cancer, ovarian cancer, or colorectal cancer
* currently pregnant
* evidence of cognitive impairment
Gender/Sex & CUD Remission

Adults (ages 18+) who would like to reduce their cannabis use (N=224) will be enrolled in an 8-week treatment program. All participants will receive counseling (1 goals session with a therapist followed by 7 weekly computerized cognitive-behavioral therapy sessions). Detailed cannabis assessments (biological and self-report) will be conducted throughout treatment and at 1-, 2-, and 3-months post-treatment completion. Daily electronic diaries will be administered via text message to record detailed logs of cannabis use quantity and frequency. Salivary samples will be collected (and video observed) daily throughout treatment to analyze for progesterone.


Eligibility Criteria:
Inclusion Criteria:

1. Willingness to participate in a research study (otherwise, will be referred to appropriate clinical services if seeking clinical care).
2. Meet current (within last 30 days) DSM-5 criteria for cannabis use disorder.
3. Submit a positive urine cannabinoid test during screening.
4. Interested in treatment for cannabis use disorder.

Exclusion Criteria:

1. Significant or acutely unstable medical or psychiatric problems (i.e., psychosis, mania) that would contraindicate research procedures, interfere with safety, compromise data integrity, or preclude consistent study participation.
2. The presence of any substance use disorder requiring a higher level of care.
3. Significant risk of homicide or suicide.
4. Pregnant, trying to become pregnant, or breastfeeding.
A Study Investigating the Movement of Lu AG09222 Into, Through, and Out of the Body of Healthy Caucasian, Chinese, and Japanese Participants

The main goal of the study is to learn more about how the body absorbs and eliminates Lu AG09222 after a single dose is injected under the skin. Researchers will also investigate safety and tolerability effects of Lu AG09222 after administration.


Eligibility Criteria:
Inclusion Criteria:

* The participant is Japanese, defined as having 4 Japanese grandparents, or the participant is Caucasian, or the participant is Chinese, defined as having 4 Chinese grandparents.
* The participant has a body mass index (BMI) ≥18 and ≤28 kilograms (kg)/square meter (m\^2) at the Screening Visit and at the Baseline Visit.

Exclusion Criteria:

* The participant has or has had any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder.
* The participant has a history of cancer, other than basal cell or Stage 1 squamous cell carcinoma of the skin or adequately treated cervical intraepithelial neoplasia, that has not been in remission for \>5 years prior to the first dose of investigational medicinal product (IMP).
* The participant has had major surgery (excluding laparoscopic cholecystectomy or uncomplicated appendectomy) \<6 months prior to the first dose of IMP.
* The participant has previously been dosed with Lu AG09222.
* The participant has a history of severe drug allergy or hypersensitivity.

Other inclusion and exclusion criteria may apply.
Sugammadex and Cognitive Function

Post operative cognitive dysfunction (POCD) is recognized as a frequent complication after both cardiac and non cardiac surgery, affecting approximately 1/3 of the patients. The aim of this study is to examine the possible effect of the novel reversal agent sugammadex versus neostigmine/ atropine combination on cognitive function of adult patients after elective surgery during the early post operative period as well as at discharge.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged \>40 years old
* ASA I-III
* Patients scheduled for elective surgery with general anaesthesia.

Exclusion Criteria:

* Neuro-, vascular-, orthopedic- or cardiac surgery
* Known psychiatric or disease of the CNS
* History of craniotomy
* Receiving tranquillisers or antidepressants on a regular basis pre-operatively
* Alcoholism or drug dependence
* History of stroke
* Refusal of patient
* Inability to read or write
* MMSE \< 22 pre-operatively