cyrilzakka/clinical-trials huggingface dataset:
Cohort of Well-differentiated Grade 3 Neuroendocrine Digestive Tumors

The purpose of this study is to analyse clinical data of well-differentiated grade 3 digestive neuroendocrine tumors. These rare tumors may have a different disease evolution, response to chemotherapy and prognostic.

Digestive neuroendocrine tumors are rare tumors and cell differentiation is a major prognostic marker of neuroendocrine tumors.

The 2010 WHO Classification defined three groups of tumor according to the combination of the morphological characteristics and the mitotic index and/or the Ki-67 index: Grade 1 and 2 corresponded to well differentiated neuroendocrine tumors whereas grade 3 corresponded to poorly differentiated lesions entitled neuroendocrine carcinomas (NEC). It was assumed that no well-differentiated neuroendocrine tumor with a mitotic- or a Ki-67- index above 20% existed.

Recently, a proportion of neuroendocrine tumors corresponding to grade 3 neuroendocrine tumors with a proliferation- or Ki-67 index \> 20% and with a well-differentiated morphology have been identified. This entity has been partially explored and may have a different survival than grade 3 NEC. Furthermore, targeted therapies, and used in pancreatic neuroendocrine tumors have not been assessed in this case.

The TENpath network is a pathological network whose goal is the systematic reading of all diagnosed cases of neuroendocrine tumors. As part of this network, nearly 3.000 neuroendocrine tumors were reviewed by pathologist experts. Of all the reviewed tumors, 167 were identified as well-differentiated grade 3 neuroendocrine tumors, observed Ki-67(5.6%) confirming the existence of this entity.

Treatment and follow-up of well-differentiated grade 3 tumors are not consensus-based and recommendations are exclusively based on experts' opinions. The purpose of this study is to define the characterization of this entity and evaluate the efficacy of chemotherapy on well-differentiated grade 3 digestive neuroendocrine tumors identified from the TENpath network.

Eligibility Criteria:
Inclusion Criteria:

* Well-differentiated grade 3 neuroendocrine digestive tumors
* Patient of 18 years old and more

Exclusion Criteria:

* Patient opposed to data collection as part of the study
* Digestive neuroendocrine tumors Grade 1-2
* Grade 3 poorly differentiated digestive neuroendocrine tumors
* Malignant disease diagnosed in the last 5 years (except basal cell of the skin and in situ cervical carcinoma)
* Other non-digestive neuroendocrine tumors
* Mixed neuroendocrine non neuroendocrine neoplasm
Sub-threshold Micro-Pulse Laser Therapy for Drusen of Dry AMD

To investigate the efficacy and safety of sub-threshold micro-pulse laser therapy for drusen of dry age-related macular degeneration (AMD) .


Eligibility Criteria:
Inclusion Criteria:

1. Older than 50 years of age.
2. Male or female patients with nonexudative AMD with a drusen diameter of at least 125um in the central 3mm circle
3. clear media to perform colour, red-free imaging and fundus fluorescein angiography, fundus autofluorescence imaging and OCT.
4. Able to give an informed consent.

Exclusion Criteria:

1. Presence of other macular disease such as epiretinal membrane, macular telangiectasia.
2. unclear media that no clear colour, red-free imaging and fundus fluorescein angiography, fundus autofluorescence imaging and OCT can performed.
3. Ocular or periocular infections.
Tenecteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-Ⅱ

A Phase Ⅲ, Multicenter, Prospective, Randomized, Open Label, Blinded-endpoint (PROBE) Controlled Trial of Recombinant Human TNK Tissue-type Plasminogen Activator (rhTNK-tPA) for Injection Versus Alteplase for Acute Ischemic Stroke Within 4.5 Hours

To test the hypothesis that rhTNK-tPA is non-inferior to alteplase in thrombolysis treatment when administered within 4.5 hours of ischemic stroke onset.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old, no gender limitation;
* The time from onset to treatment was \< 4.5h;The time at which symptoms begin is defined as "the time at which they finally appear normal";
* The clinical diagnosis was ischemic stroke (the diagnosis followed the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018);
* MRS before onset was 0-1 points
* Baseline NIHSS 5-25(both included);
* Informed consent from the patient or surrogate.

Exclusion Criteria:

* Intended to proceed endovascular treatment;
* NIHSS consciousness score \>2;
* Allergy to tenecteplase or alteplase;
* Past history of intracranial hemorrhage ;
* A history of severe head trauma or stroke within 3 months;
* A history of intracranial or spinal surgery within 3 months;
* A history of gastrointestinal or urinary bleeding within 3 weeks;
* 2 weeks of major surgery;
* Arterial puncture was performed at the hemostasis site that was not easily compressed within 1 week;
* Intracranial tumors (except neuroectodermal tumors, such as meningiomas), large intracranial aneurysms;
* Intracranial hemorrhage (including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/extradural hematoma, etc.);
* Active visceral bleeding;
* Aortic arch dissection was found;
* After active antihypertensive treatment, hypertension is still not under control: systolic blood pressure ≥180 mm Hg, or diastolic blood pressure ≥100 mm Hg;
* Propensity for acute bleeding, including platelet counts of less than 100×109/ L or otherwise;
* Blood glucose \<2.8 mmol/L or \>22.22 mmol/L;
* Oral warfarin anticoagulant with INR\>1.7 or PT\>15 s;
* Heparin treatment was received within 24 h;
* Thrombin inhibitors or factor Xa inhibitors were used within 48 h;
* Head CT or MRI showed a large infarction (infarcted area \> 1/3 of the middle cerebral artery);
* Subjects who are unable or unwilling to cooperate due to hemiplegia (Todd's palsy) after epileptic seizure or other neurological/psychiatric disorders;
* Pregnant women, lactating women, or subjects who do not agree to use effective contraception during the trial;
* Participation in other clinical trials within 3 months prior to screening;
* Unsuitability or participation in this study as judged by the Investigator may result in subjects being exposed to greater risk.
How Parents Can Help Babies Learn to Talk With Picture Books.

The aim of this project is to test whether giving parents advice about book reading is effective in promoting language learning for infants from a range of socio-economic backgrounds.

Children from disadvantaged families tend to have limited language skills compared to their advantaged peers. While many factors contribute to language ability, two aspects of the early caregiving environment are known to be correlated with child language outcomes 1) caregiver-child book reading and 2) caregiver contingent talk. Contingent talk refers to a style of communication whereby the caregiver talks about what is in their infant's current focus of attention. This style of talking can be facilitated when parents read books with their babies. The aim of this research is to establish whether asking parents to engage in contingent talk in the context of book reading promotes vocabulary learning. This study will compare the effects of an intervention to promote contingent talk against a control where parents are given books but not given any training in how to read them in a contingent manner. The study will include children from socio-economically advantaged and disadvantaged families.

Eligibility Criteria:
Inclusion Criteria:

Infants must be:

* first born and singletons
* full term (i.e. born no more than 3 weeks prematurely)
* with birth weight over 2.5 kg.

Primary caregivers must:

* work less than 24 hours per week (i.e., be the caregiver the child spends most time with)
* be raising their child as monolingual English speakers.

Exclusion criteria:

Neither caregivers nor infants must have any significant known physical, mental or learning disability.
Lung Ultrasound in Diagnosis and Management of Bronchiolitis Bronchiolitis

To evaluate the correlation between clinical and ultrasound findings in children presented with signs suggestive of bronchiolitis and to validate an ultrasound score for bronchiolitis that will correlate with specific clinical outcomes.


Eligibility Criteria:
Inclusion Criteria:

* children presented with signs suggestive of bronchiolitis

Exclusion Criteria:

* other major pathology
Team-Based Delivery of Care in Outpatient Settings

Through this research we intend to evaluate whether a team-based care delivery approach using daily huddles is effective in improving caregiver and patient outcomes in primary care setting. This approach is expected to not only lead to effective primary care delivery outcomes, but also result in greater team morale, reduced burnout, and a higher rate of innovation.


Eligibility Criteria:
Inclusion Criteria:

* 18 year old adult
* member of Mayo care team in the Midwest

Exclusion Criteria:

-Unable to provide consent
Study of Effectiveness of Mental Health Interventions Among Torture Survivors in Southern Iraq

1. That the psychotherapeutic intervention - Components-Base Interventions (CBI) - is effective in reducing the severity of mental health symptoms experienced by torture survivors in Southern Iraq.
2. That the psychotherapeutic intervention - Cognitive Processing Therapy (CPT) - is effective in reducing the severity of mental health symptoms experienced by torture survivors in Southern Iraq.

For each intervention, participants will undergo 12 sessions (CBI or CPT) that are standardized by training and manual for community mental health workers (CHMWs). CMHWs will be trained in only one intervention. Prior to the starting sessions, a baseline assessment of depression, anxiety and trauma symptoms and function will be carried out. A follow up assessment will be carried out after the 12 sessions have been completed. Expected time between sessions is one week. The total time per client is expected to last about 4-5 months to complete the 12 therapy sessions.

Participants will be randomized (within CMHW) to either immediate intervention or wait-list control. Participants that are wait-list control will be contacted monthly for assessment of condition. Any participant (intervention or control) with suicidal thoughts or distress that does not abate will be referred for psychiatric care.

Eligibility Criteria:
Inclusion Criteria:

* Exposure to Torture
* PTSD

Exclusion Criteria:

* Children
* Mentally incompetent to understand therapy
Evaluating the Effectiveness of the GILL eHealth Intervention to Improve Physical Health and Lifestyle Behaviours in Patients With Severe Mental Illness

The aim of this study is to evaluate the effectiveness of the nurse-led GILL (Gezondheid in Lichaam en Leefstijl) eHealth intervention in patients with serious mental illness (SMI), compared to usual care. Expected is that the GILL eHealth intervention will be more effective than usual care in improving physical health and lifestyle behaviors. To evaluate this, we will perform a cluster randomized controlled trial with an embedded process evaluation of the implementation of the GILL intervention. 258 adult patients with serious mental illness and a body mass index of 27 or higher (overweight/obesity) will be included. The GILL eHealth intervention consists of two complementary modules for (a) somatic screening and (b) lifestyle promotion, resulting in a personalized somatic treatment and lifestyle plan. Trained mental health nurses and clinical nurse specialists will implement the intervention within the multidisciplinary treatment context, and will guide and support the patients in the promotion of their somatic health, including cardiometabolic risk management. The intervention will be compared to usual care, which includes treatment according to national guidelines. The outcome measures will be metabolic syndrome severity (primary), fitness, physical activity, lifestyle behaviors, quality of life, recovery, psychosocial functioning, health related self-efficacy and health care utilization after 1 year. The process evaluation focuses on the feasibility of the eHealth intervention, its acceptability for patients and health care providers (mainly mental health nurses and clinical nurse specialists), and barriers/facilitators to implementation.


Eligibility Criteria:
Inclusion Criteria:

* Meet the criteria of severe mental illness
* Aged from 18 to 65 years
* Body mass index (BMI) ≥ 27
* Access and ability to use internet
* Able and willing to sign informed consent

Exclusion Criteria:

* Contra-indications (to be assessed by the treating physician/psychiatrist) for participation due to acute psychiatric crisis or severe somatic diseases
* Subjects with a cognitive impairment sufficient to interfere with their ability to provide informed consent, complete study questionnaires, or participate in the intervention
* Pregnant or breastfeeding women at the time of inclusion
* Subject not able to communicate in the Dutch language
Oral Contraceptive (OC) Estrogen Dose and Breast Proliferation

The purpose of this research study is to gain a better understanding of the changes that may occur in the breast when a woman uses an oral contraceptive (birth control pill). Some research indicates that women who use birth control pills with lower amounts of estrogen (a hormone in the birth control pill) may have lower breast cell growth than women who use birth control pills with a higher amount of estrogen; this research will examine that in detail. This research will also test whether the results found in HS-07-00269 can be confirmed.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-35
2. BMI \<30 kg/m2
3. Premenopausal with regular cycles or currently taking an OC
4. Not currently or recently pregnant or nursing (within previous 6 months)
5. Non-smoker
6. No use of antibiotics within the prior 4 weeks
7. Competent to provide written informed consent (as judged by study team)
8. Willing to adhere to the OC regimen
9. Willingness to refrain from the use of aspirin or NSAIDS 10 days pior to the biopsy appointment and one week following the biopsy procedure
10. Willing and able to refrain from use of fish oils 10 days prior to the biopsy appointment and one week following the biopsy procedure

Exclusion Criteria:

1. Diabetes
2. Abnormal breast examination
3. Abnormal PT/INR and/or CBC with platelets test results (as determined by one of the study physicians)
4. History or current therapeutic or prophylactic use of anticoagulants
5. Known bleeding disorder or history of unexplained bleeding or bruising
6. History of breast cancer or previous diagnostic breast biopsy
7. Known allergy to local anesthetic
Olanzapine Versus Midazolam for Agitation

The goal of this research investigation is to conduct a prospective observation of the comparative efficacy of midazolam versus olanzapine for the treatment of acute undifferentiated agitation in the emergency department.

The goal of this research investigation is to conduct a prospective observation of the comparative efficacy of midazolam versus olanzapine for the treatment of acute undifferentiated agitation in the emergency department.

In the summer of 2017, the ED implemented a treatment protocol as a quality improvement initiative. The investigators performed observational research on this protocol and identified that haloperidol and ziprasidone were inferior to midazolam and olanzapine for treating agitation in our Department.

The comparison between olanzapine and midazolam, however, was inconclusive. It is possible that this is due to inadequate power, so the question of whether olanzapine or midazolam is superior is still unknown.

Because the department continues to strive to achieve the best care for this patient population, in the Summer of 2018 the ED is going to initiate a second ED treatment protocol of olanzapine and midazolam, based on the results of our 2017 protocol.

All patients requiring chemical sedation for will receive olanzapine as the initial treatment for agitation for 6 weeks, followed by midazolam as the initial treatment for agitation for 6 weeks. These patients will be observed by research staff.

This is a clinical care quality improvement protocol. The clinical protocol is not research. The research component is the observation of this clinical care protocol.

Eligibility Criteria:
Inclusion Criteria:

* Emergency Department patients
* Patients 18 years and older
* Patients with acute undifferentiated agitation requiring chemical sedation at the discretion of the attending emergency physician will be observed.

Patients meeting these criteria who receive medications in the ED will be observed by research staff, evaluating efficacy and safety of the administered medication.

Exclusion Criteria:

- There are no exclusion criteria per se as this is only observational research. The decision to administer the medication is at the discretion of the physician. Research protocols are only such that we are observing the efficacy and safety, which coincides the quality improvement purposes of this clinical protocol. Patients will be provided an Information Sheet and can opt to have their data removed.

Patients who are prisoners, children, will NOT have their data collected
A Study of Lu AG06466 for the Treatment of Spasticity in Participants With Multiple Sclerosis

The main purpose of this study is to investigate Lu AG06466 as a treatment for spasticity in participants with multiple sclerosis (MS).

The participants will be randomized to Lu AG06466 or placebo in a 2:1 ratio.

Eligibility Criteria:
Key Inclusion Criteria:

* The participant has a diagnosis of MS, as per the 2017 McDonald criteria.
* The participant has clinically stable MS (such as no relapse and/or stable Expanded Disability Status Scale \[EDSS\] or alternative clinical assessment score) for at least 6 months prior to screening.
* The participant has ongoing spasticity for at least 90 days prior to screening.
* The participant is on a stable regimen for at least 30 days prior to screening for all medications and non pharmacological therapies, including therapies that are intended to alleviate spasticity (for example, oral baclofen, tizanidine, dalfampridine), and willing to remain on the same regimen throughout the duration of the study.
* The participant reports walking impairment due to lower limb spasticity.

Key Exclusion Criteria:

* The participant has any concomitant disease or disorder that has spasticity-like symptoms or that may influence the participant's level of spasticity or the participant's overall ability to participate in the study.
* The participant has ambulation difficulties due to any concomitant disease or disorder other than MS.
* The participant has any known or suspected hypersensitivity to cannabinoids (CBs) or any of the excipients of the investigational medicinal product (IMP).
* The participant has a positive drug screening test, except for non-CB medications used to treat a medical condition and reported as such by the participant; the participant has a positive drug screen test for cannabis/delta-9-tetrahydrocannabinol.

Other inclusion and exclusion criteria may apply.
HIV Testing in Pregnant Women: Evaluating an Opt-Out Testing Strategy

Mother-to-child transmission of HIV is an important but preventable mode of infection. Prevention depends on identifying pregnant women infected with HIV and offering medications during pregnancy which can dramatically decrease the chances of transmission. Currently universal screening of all pregnant women for HIV is recommended in the province of Ontario. Unfortunately the rates of screening are still low: estimates place the average rate at 50% -60%. We believe that rates in our clinic at the Women's Health Care Centre are significantly higher in part because all our patients have a first obstetrical visit. This is an unhurried visit with a trained obstetrical nurse who offers pre-test counselling and explores reasons why patients refuse testing. We hypothesize that with this system, acceptance rates for HIV screening are significantly higher than the provincial average.

We hypothesize that by having a dedicated and unhurried intake visit with a trained obstetrical nurse, pregnant women will be more likely to accept antenatal HIV testing. We further hypothesize that in our obstetrical clinic at the Women's Health Care Centre, the application of a universal opt-out screening policy will result in a testing rate that is higher than the provincial average.

This is a two part study. The first part will be a retrospective chart review while the second part will be a prospective cohort study. All antenatal patients with first visits at our clinic will be included. For the retrospective portion, 537 charts will be reviewed. For the prospective portion, 537 patients will be enrolled prospectively using a data sheet which will be included in all charts starting when the study begins. For both portions, the following information will be obtained:

* presence of HIV test
* result of test
* if test not performed, the reason documented, in any
* if testing refused, the reason for refusal

Additional information that will be obtained includes:

* number of HIV positive pregnant women cared for in our clinic during the study period
* percentage of positive cases
* difference in testing (acceptance) rates between the retrospective and prospective (when data sheet in use) portions of the study.

Eligibility Criteria:
Inclusion Criteria:

* All pregnant women attending antenatal intake appointments at the Women's Health Care Centre at St. Michael's Hospital in Toronto, Canada between September 2003 and February 2005.

Exclusion Criteria:

* Any pregnant women obtaining antenatal care at other health care facilities.
Personalized Antisense Oligonucleotide Therapy for a Single Participant with ATN1 Gene Mutation

This research project entails delivery of a personalized antisense oligonucleotide (ASO) drug designed for a single participant with dentatorubral-pallidoluysian atrophy (DRPLA) due to a heterozygous pathogenic CAG trinucleotide expansion in ATN1

This is an interventional study to evaluate the safety and efficacy of treatment with an individualized antisense oligonucleotide (ASO) treatment in a single participant with DRPLA due to a heterozygous pathogenic CAG trinucleotide expansion in ATN1

Eligibility Criteria:
Inclusion Criteria:

* Informed consent/assent provided by the participant (when appropriate), and/or participant's parent(s) or legally authorized representative(s).
* Ability to travel to the study site and adhere to study-related follow-up examinations and/or procedures and provide access to participant's medical records.
* Genetically confirmed Dentatorubral-pallidoluysian atrophy (DRPLA) due to ATN1 mutation

Exclusion Criteria:

* Use of investigational medication within 5 half-lives of the drug at enrolment
* Participant has any condition that in the opinion of the Site Investigator, would ultimately prevent the completion of study procedures.