cyrilzakka/clinical-trials huggingface dataset:
Relationship Training for Children With Autism and Their Peers

This study will determine whether peer interaction training interventions are effective in enhancing the social relationships of children with autism.

Children with autism often have poor relationships with other children during their childhood and through their adult lives. A number of peer-related intervention models have been developed, but these models have not been thoroughly reviewed or implemented within the school setting. This study will examine the social inclusion of children with autism, following different peer-related interventions training children with autism and their peers.

Children will be randomly assigned to one of four interventions that comprise all autistic children, all nonautistic children, or a mixed group of both. The first intervention focuses on improving the social skills of autistic children. The second intervention involves educating the peers of autistic children to increase their acceptance of their autistic peers. The third intervention is a combination of the first two interventions. Children assigned to the fourth intervention will receive the usual training offered in their local school districts. Training for each group will be conducted twice a week for 6 weeks.

Characteristics of the autistic child will be assessed through an interview that evaluates intelligence quotient (IQ), language skills, and social interaction. Teachers will be asked to complete a questionnaire describing the autistic child and his or her interaction with peers. The autistic children will complete a friendship survey, clinical global impressions scales, and a battery of neuropsychiatric tests. All assessments will be conducted at study start and again at study completion.

Eligibility Criteria:
Inclusion Criteria for Autistic and Nonautistic Participants:

* Autistic OR nonautistic peer of autistic child
* Full inclusion in a classroom with nonautistic children
* Currently in kindergarten or grades 1 through 5
* Intelligence quotient higher than 70
* Expectation to stay in the same school and classroom for the duration of the study
* Able to provide parent consent and child assent

Exclusion Criteria:

* Mental age-equivalent less than 4 years
* Conditions other than autism, or sensory or motor impairments
Premanifest Huntington's Disease Extension Study II: Creatine Safety & Tolerability

The purpose of this clinical trial is to extend the Pre-Crest-X study to further assess the long-term safety and tolerability of up to 30 grams daily creatine in individuals at-risk for Huntington's Disease (HD) and to assess whether biomarkers responsive to creatine in symptomatic individuals are informative in premanifest individuals over a longer duration.

Extensive evidence exists that neurodegeneration begins many years before HD can be diagnosed clinically. Therefore, it is most desirable to begin a neuroprotective therapy before or during this premanifest period with the aim of delaying onset, as well as slowing functional decline. Cellular energy depletion is present early in HD and can be ameliorated by creatine, which helps regenerate cellular ATP. Preclinical evidence for creatine's potential neuroprotective effects in animal models of HD has been well-documented. Before the clinical efficacy of creatine can be tested in premanifest HD, its long-term safety and tolerability must be assessed in these individuals and its ability to favorably modify biomarkers of HD should also be confirmed. This extension trial will continue to follow eligible individuals who completed the Pre-CREST-X extension study on open-label creatine (up to 30 grams daily) for long term safety and tolerability for an additional 24 months. Other biological and imaging biomarkers of disease progression and potential response to treatment will also be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Individuals who have completed the Pre-CREST Study.
* Individuals capable of providing independent informed consent and complying with trial procedures.

Exclusion Criteria:

-Clinical evidence of unstable medical or psychiatric illness in the investigator's judgment.

Additional eligibility criteria apply.
Pulmonary Embolism WArsaw REgistry

Initiated in January 2008, The PE-aWARE (Pulmonary Embolism WArsaw REgistry) is an on-going single-centre prospective observational study of patients with confirmed acute pulmonary embolism (APE). Extensive data on consecutive patients with pulmonary embolism is collected and stored. The main objective is to collect and provide information on patients' characteristics, management, and outcome with the purpose of decreasing mortality in APE, the occurrence of bleeding, and the frequency of thromboembolic recurrences. Moreover, the PE-aWARE registry serves as a basis for creating predictive scores for clinicians which aid patient management. The study endpoints comprise clinically recognized (and objectively confirmed) recurrences of PE, major and minor bleeding complications classified according to the International Society on Thrombosis and Haemostasis classification, need for cardiopulmonary resuscitation or catecholamines, and death.

The Pulmonary Embolism WArsaw REgistry (PE-aWARE) is an on-going prospective observational study of patients with confirmed acute pulmonary embolism (APE). Carried out since January 2008, the registry includes consecutive patients hospitalized at a single centre. The primary data recorded include details of each patient's clinical status, co-morbidities, the prescribed treatment, the results of additional studies (ie EKG, imaging studies), and the outcome. The study endpoints comprise clinically recognized (and objectively confirmed) recurrences of PE, major and minor bleeding complications classified according to the International Society on Thrombosis and Haemostasis classification, need for cardiopulmonary resuscitation or catecholamines, and death.

Collecting the fore mentioned data allows for clinicians to better manage the diagnostic workup and treatment and thus facilitates the prevention of possible future complications in APE patients.

Eligibility Criteria:
Inclusion Criteria:

* objectively confirmed pulmonary embolism
* Informed consent for the participation in the study, according to the requirements of the ethics committee

Exclusion Criteria:

* lack of consent
Does Fluoxetine Have an Effect on the CNS CRF Systems in Women Abused in Childhood?

The primary objective of this project is to determine whether treatment with the SSRI, fluoxetine versus placebo reverses alterations in the central CRF system induced by early life stress experiences (i.e. childhood sexual and/or physical abuse) in cases with and without major depression. We also evaluate whether neuroendocrine changes after SSRI treatment correlate with clinical improvement.

We compare indices of central CRF activity (i.e. ACTH and cortisol response to CRF stimulation test) before and after 8 weeks of treatment with either fluoxetine or placebo between women with a history of childhood abuse (early life stress, ELS) and current major depression (ELS/MDD), women with a history of childhood abuse without major depression (ELS/non-MDD), and women without a history of childhood abuse and major depression (non-ELS/MDD). Changes in neuroendocrine responses to CRF are correlated with psychological outcome measures. We hypothesize that treatment with fluoxetine will normalize altered neuroendocrine responsiveness in cases with ELS and that this normalization will be correlated with improvement of symptoms of depression and anxiety.

Eligibility Criteria:
Inclusion Criteria:

1. For all subjects female gender;
2. For subjects assigned to the MDD groups, current DSM-IV diagnosis of MDD;
3. For subjects assigned to the early-life stress group, repeated (once per month or more for at least year) sexual or physical abuse before the age of 12 years by a perpetrator at least 5 years older at the time;
4. For all subjects, age of 18 to 45 years;
5. Regular menstrual cycle and assessment in the early follicular phase as verified by sex steroid measures.

Exclusion Criteria:

1. For all subjects, gender identity disorders;
2. For all subjects assigned to non-MDD groups, DSM-IV diagnosis of current MDD;
3. For all subjects assigned to the group without early-life stress, major stress experiences before the age of 12 years, such as separation from parents, neglect, parental loss, accidents, severe illness or natural disaster;
4. For all subjects, significant medical illness, such as gastrointestinal, neurological, endocrine, cardiovascular, pulmonary, renal, hepatic, immunological or hematological disease, organic brain disease, or cancer as determined by history, physical examination, ECG, and laboratory tests;
5. Pregnancy or nursing;
6. For all subjects, past or current presence of psychotic symptoms or bipolar disorder;
7. For all subjects, current presence of psychoactive substance abuse/dependency or eating disorders;
8. For all subjects, hormonal medication;
9. For all subjects, psychotropic medication in the four weeks prior to study entry;
10. For all subjects, inability to provide informed consent.
Lux-Breast 3; Afatinib Alone or in Combination With Vinorelbine in Patients With Human Epidermal Growth Factor Receptor 2 (HER2) Positive Breast Cancer Suffering From Brain Metastases

The aim of this study is to investigate the efficacy and safety of afatinib alone or in combination with vinorelbine, as treatment in patients with HER2-overexpressing metastatic breast cancer, who have progressive brain lesions after trastuzumab and/or lapatinib based therapy


Eligibility Criteria:
Inclusion criteria:

1. patients with HER2 positive breast cancer with a documented central nervous system (CNS) recurrence/progression (by imaging) during or after a HER2 inhibitor (Trastuzumab and/or Lapatinib) based therapy (no leptomeningeal carcinomatosis as the only site of CNS metastases)
2. at least one measurable and progressive lesion in the brain (=10 mm on T1-weighted, gadolinium-enhanced Magnetic Resonance Imaging). Measurable or non measurable extracranial metastases allowed.
3. previous treatment with HER2 inhibitors to be discontinued prior to first study treatment administration (at least 14 days for trastuzumab and other antibodies, at least 7 days for lapatinib).
4. previous chemotherapy and hormonal therapy (adjuvant and metastatic regimens) allowed, but chemotherapy must have been discontinued at least 14 days and hormonal therapy at least 7 days prior to first study treatment administration.
5. Patients must have recovered to baseline condition or to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 grade = 1 from any acute CTCAE v. 3.0 grade =2 side effects of previous treatments.
6. prior surgery, whole brain radiotherapy or stereotactic radiosurgery allowed provided that there is unequivocal evidence of one or more new and/or progressive brain metastases after completion of whole brain radiotherapy or stereotactic radiosurgery.

Exclusion criteria:

1. Prior treatment with HER2- tyrosine kinase inhibitor other than lapatinib
2. Any other current malignancy or malignancy diagnosed within the past five (5) years (other than bilateral primary breast cancer, metastases to the contralateral breast, non-melanomatous skin cancer and in situ cervical cancer).
3. Significant chronic or recent acute gastrointestinal disorders with diarrhoea as a major symptom e.g. Crohn's disease, malabsorption or Common Terminology Criteria (CTC) grade =2 diarrhoea of any aetiology.
Use of Hydroxychloroquine Alone or Associated for Inpatients With SARS-CoV2 Virus (COVID-19)

The Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV2) has been identified in Wuhan, China, which causes severe pulmonary complications and flu syndrome, which has spread rapidly to all continents. Approximately 25% of hospitalized patients require treatment in intensive care units and 10% require mechanical ventilation. The diagnosis is made by the molecular polymerase chain reaction test. However, diagnostic tests are limited. The clinical care of the patient with COVID-19 is similar to that of patients with severe infectious respiratory complications, consisting of support and oxygen supplementation. Several medications have been tested as remdesivir, a pro-drug nucleoside, which acts by inhibiting viral RNA transcription, although a recently published study has shown no benefit. China recently approved the use of favipiravir, an antiviral used for influenza, as an experimental therapy for COVID-19. Hydroxychloroquine is a drug with great potential treatment, as it can inhibit the pH-dependent steps of replication of various viruses, with a potent effect on SARS-CoV infection and spread. In this way, the present study will evaluate the safety and efficacy of the hydroxychloroquine in patients with symptomatic SARS-Cov2.


Eligibility Criteria:
Inclusion Criteria:

* Males and females aged \> 18 years;
* Patients with flu syndrome (fever greater than 37.8C or feverish feeling referred by the patient associated with at least 1 respiratory symptom: cough, difficulty breathing, sputum production, nasal or conjunctival congestion, difficulty swallowing, sore throat, runny nose, signs cyanosis, flapping of the nose and dyspnoea);
* Diagnosis confirmed by real-time PCR or suspected COVID-19;
* Hospitalized patients with:
* Moderate disease: hypoxemia with O2 saturation \<93% in room air and / or respiratory rate greater than or equal to 24 incursions per minute and / or radiological evidence of pneumonia with pulmonary impairment less than 50%;

or

* Serious illness: Hospitalized patients with hypoxemia with O2 saturation \<93% in room air and / or respiratory rate greater than or equal to 24 incursions per minute with radiological evidence of pneumonia with pulmonary involvement above 50% and / or the presence of sepsis ( organ failure) or need for invasive mechanical ventilation.

Exclusion Criteria:

* Mild cases of flu-like syndrome that do not require hospitalization or O2 saturation greater than or equal to 93% and without radiological evidence of pneumonia;
* Liver failure or elevation of transaminases greater than 5 times;
* Cardiac patients with electrocardiogram with extended QT interval;
* Pregnant women;
* Use in the last 30 days of hydroxychloroquine or azithromycin;
* Allergy to hydroxychloroquine or azithromycin.
Ultrasound and Photoacoustic Imaging for Cervical Cancer

The investigators have developed co-registered transvaginal photoacoustic and ultrasound (US) imaging techniques that allow them to visualize ovarian tumor structure and functional changes simultaneously, which may potentially reveal early tumor angiogenesis development or residual tumors after systemic treatment that is not available by US alone. The ability to detect early angiogenesis changes, as well as tumor morphology changes using a non-invasive imaging modality will greatly enhance the care for patients. The investigators plan to explore these techniques in monitoring cervical cancer treatment response and conduct pilot feasibility studies.


Eligibility Criteria:
* Diagnosis of cervical cancer of any stage that will be treated with radiation therapy and concurrent chemotherapy.
* At least 18 years of age.
* Not pregnant and/or breastfeeding.
* Able to understand and willing to sign an IRB-approved written informed consent document.
How Menopause Affects Lipid Metabolism in the Visceral Fat Depots

The purpose of the study is to describe the molecular mechanisms related to an increased visceral fat mass and changed T-cell homeostasis. the project is expected to add new knowledge to the field of metabolic diseases after menopause and increase the focus of how lipid affects the development of metabolic disease in relation to the menopausal transition.

The study is a cross sectional study including 60 women between 45 and 55 years of age. Investigators aim to include 20 premenopausal women, 20 postmenopausal women and 20 postmenopausal women taking hormone treatment (HT). All the women are going through gynecological surgery for benign reasons. During the operation investigators will take a visceral fat biopsy from the omentum.

maximally 1 month before- or after the operation the subject will meet at the lab for further testing, including:

* Health examination
* Blood samples
* OGTT
* DXA scan
* VO2 max testing
* MRI of the abdomen
* hyperinsulinemic euglycemic clamp

Eligibility Criteria:
Inclusion Criteria:

* women
* 45-55 years old
* for HT treated women (HT more than 1 year)

Exclusion Criteria:

* Infections during the last month
* chronic disease
* claustrophobia
* smoking
* Alcoholic intake \> 14 servings
* hysterectomy before menopause
* oophorectomized
* early menopause (before 40 yrs)
* BMI \> 30
Segmental Epidural Block for Feeding Jeujunostomy in Cancer Patients

This study aim is to compare the efficiency and safety of segmental epidural block versus general anesthesia in cancer patients undergoing surgical feeding jejunostomy

Comparing general anesthesia versus segmental epidural anesthesia in feeding jejunostomy

Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for surgical feeding jejunostomy more than 18 years old

Exclusion Criteria:

* patien refusal Coagulation defect Abnormal kidney or liver functions Local infection at site of block Bone metastases
Changes in Semen or Sperm Caused by Temozolomide in Patients With Newly Diagnosed, Progressive, or Recurrent Primary Malignant Brain Tumors

RATIONALE: Learning whether temozolomide changes semen or sperm in patients with brain tumors may help doctors learn about the long-term effects of treatment and plan the best treatment.

PURPOSE: This clinical trial is studying changes in semen or sperm caused by temozolomide in patients with newly diagnosed, progressive, or recurrent primary malignant brain tumors.

OBJECTIVES:

Primary

* Assess if temozolomide induces any changes in standard semen or sperm analysis parameters (i.e., volume, viscosity, pH, forward progression, total count, total motile count, motility, presence of round cells, agglutination, and morphology) in patients with newly diagnosed, recurrent, or progressive primary malignant brain tumors.

OUTLINE: This is a pilot study.

During treatment with temozolomide, patients undergo semen or sperm sample collection at baseline, 3 months, and 6 months for semen analysis. Samples are analyzed for volume, viscosity, pH, forward progression, total count, total motile count, motility, presence of round cells, agglutination, and morphology.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed primary malignant brain tumor

  * Newly diagnosed, progressive, or recurrent disease
  * May have received prior radiotherapy with or without chemotherapy
  * Scheduled to begin single-agent temozolomide chemotherapy
* Must be able to ejaculate

  * Must abstain from ejaculating (e.g., not have sex or masturbate) for 2-7 days prior to study
* No known abnormal sperm motility and/or morphology

PATIENT CHARACTERISTICS:

* Karnofsky performance status 60-100%

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
FilmArray and Management of ICU Patients With Pneumonia in the Covid-19 Context

The research aims to determine the impact of a syndromic mutiplex PCR assay (FilmArray) on the management of patients hospitalized in ICU for severe respiratory disease.

During the SARS-CoV-2 outbreak, the diagnosis of pneumonia has become considerably more complex as the biological, radiological and clinical criteria of covid-19 interfere with the standard criteria for the diagnosis of severe respiratory diseases. Moreover, patients with COVID-19 are at higher risk of developing other associated infections and thus, patients have therefore often been treated with antibiotics, adequately or not, due to difficulty to quickly identify the etiology of their symptoms with conventional methods.

In order to improve their treatment, both diagnostic and therapeutic, we set up a new syndromic molecular test in our laboratories to accelerate and improve the pneumonia management and antibiotic stewardship. This research will include 100 to 150 adult patients hospitalized in ICU during the first half of 2020. It will take place within the Nancy University Hospital and the Reims University Hospital, France.


Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years affiliated to a social security system
* Patients who have received complete information about the research and who have not objected to the use of its data
* Patients with suspected SARS-Cov-2 infection
* Patients for which a FilmArray test has been realized on its respiratory samples between 1st of March and 1st of July 2020.

Exclusion Criteria:

* None
Follow up Study on Visual Prognosis and Complications of Ectopia Lentis Lens

This is a single-centre, observational cohort study with the following objectives: Firstly, the investigators aim to evaluate the vision-related quality of life and mental health status in congenital ectopia lentis patients. Secondly, the investigators target to investigate the correlations between genotype and clinical phenotype in patients of congenital ectopia lentis. Thirdly, to explore the metabolic profiles in the aqueous humor (AH) of patients with congenital ectopia lentis. Lastly, this study aims to explore the longitudinal changes of ocular biological parameters and complications in patients with postoperative congenital ectopia lens in the Chinese population.

Congenital ectopia lens is a rare ophthalmic disease that seriously harms the physical and mental health of patients. Surgery is the only definite treatment at present. However, the changes in vision-related quality of life, mental health status, ocular biological parameters postoperative congenital dislocation of lens have not been systematically studied in the Chinese population.

In this trial, the investigators aim to evaluate the vision-related quality of life and mental health status in congenital ectopia lentis patients, investigate the correlations between genotype and clinical phenotype in patients of congenital ectopia lentis, explore the metabolic profiles in the aqueous humor (AH) of patients with congenital ectopia lentis, and explore the longitudinal changes of ocular biological parameters and complications in patients with postoperative congenital ectopia lens in the Chinese population.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with congenital lens dislocation and age ≥ 3 years old.
* Agree to participate in this study with written informed consent from patients or legal guardians.

Exclusion Criteria:

* History of ophthalmic trauma or other ophthalmic surgeries.
* Combined with other ophthalmic diseases such as primary glaucoma, uveitis and corneal disease.
* Patients who could not cooperate in the examinations.