cyrilzakka/clinical-trials huggingface dataset:
Pilot Study of Novel Postpartum Educational Video Intervention

A child's early language environment is pivotal for language development. Disparities in early language environments contribute to the gap in school readiness between poor and more advantaged children. Ultimately this leads to disparities in students' school achievement and economic outcomes. While recent research has highlighted the value of early intervention for children in disadvantaged families, most existing interventions begin too late, reach only a small proportion of children at risk, and do not capitalize on the critical role that parent language plays in a child's educational trajectory. To address this challenge, the investigators propose to develop and evaluate a novel language-based, perinatal public health intervention, Thirty Million Words Newborn Initiative (TMW-NI). It is proposed that new mothers will receive this educational intervention while their babies are undergoing the universal newborn hearing screen. The intervention will use video, animation, and interactive questions to convey the importance of the early language environment and to illustrate strategies parents can use to promote language learning. The investigators will conduct formative research with mothers of low socioeconomic status (low-SES) and with healthcare providers to inform the content and format of the intervention prototype. Also critical for acceptability, the investigators will use an iterative approach to develop the intervention, with review of the work-in-progress by the intended audience. To assess feasibility and initial efficacy, the investigators will conduct a randomized-controlled trial with low-SES mothers during the newborn period. The investigators hypothesize that TMW-NI will positively impact parents' knowledge and beliefs about the role of language input for a child's language development.


Eligibility Criteria:
Inclusion Criteria:

-Postpartum mothers admitted to the mother-baby unit.

Exclusion Criteria:

* Mothers of infants who were admitted to the neonatal intensive care unit (NICU).
* Mothers who experienced any serious medical complications during birth.
* Mothers who do not expect to reside in Illinois for the duration of the study (approximately two months).
Impact of Telehealth on Engagement in Psychotherapy and/or Medication Treatment

In the present study, investigators aim to (1) adapt the Making Connections Intervention (MCI) as an intervention to address telehealth engagement and examine whether this targeted intervention can improve youth engagement in telehealth treatment; and (2) assess attitudes towards help-seeking and therapeutic alliance from both the youth and clinician viewpoint to examine the impact of these factors on engagement in telemental health treatment. Forty adolescent participants ages 12-18 will be randomized to either telehealth treatment as usual (TAU) plus the telehealth Making Connections Intervention (MCI-T) engagement session or telehealth TAU alone and followed for 12 weeks from baseline assessment. All clinicians will receive training in the MCI-T intervention and provide either MCI-T + usual care or usual care only depending on the condition to which the adolescents are randomized. All evaluations and therapy sessions will be done over telehealth platform.

Clinicians who participate in the study may be assigned more than one study case, and therefore will complete measures on each study case. All of the clinicians will receive training in the Making Connections Intervention-Telehealth (MCI-T) intervention. The clinicians will deliver the intervention based on the random assignment of the adolescent participants to a treatment arm. When clinicians provide care to adolescents randomized to the MCI-T condition, they will participate in a monthly consultation over telehealth to review cases to promote adherence and fidelity to the treatment.

Eligibility Criteria:
Inclusion Criteria: Youth Sample

1. Youth ages 12-18 years of age receiving an evaluation in the diagnostic evaluation service, the Diagnostic Evaluation and Stabilization Clinic (DESC), or another clinical service in the outpatient Child Behavioral Health Service at NewYork Presbyterian (NYP) - Morgan Stanley Children's Hospital (MSCH)/ NYP-MSCH.
2. English speaking

Exclusion Criteria: Youth Sample

1. Active Suicidal Ideation with current plan and/or intent that requires a higher level of care than outpatient treatment or treatment in DESC
2. Diagnosis of intellectual disability

Inclusion Criteria: Clinician Sample

1. Work as a clinician in any MSCH Outpatient Behavioral Health Service or DESC
2. Clinician consent
3. English or bilingual in English and Spanish

Exclusion Criteria: Clinician Sample

1. None
Predictors of Postoperative Pain Following Oocyte Retrieval for Assisted Reproduction

The central objective of this study will be to evaluate the relationship between estrogen levels and the pain following oocyte retrieval in women undergoing in vitro fertilization.

Subject will undergo standard clinical protocols for the entire oocyte stimulation cycle and all assisted reproductive procedure decisions and algorithms will be decided entirely independent of this study.

The anesthetic and postoperative pain regimens will use the same agents and dose ranges used in clinical standard practice; however, the regimens will be standardized, so as to limit confounding variables. The study regimen for anesthesia will differ from the current, clinical standard by the mandated use of actual body weight (in current practice, actual, adjusted ideal, or ideal body weights are used), the use of fentanyl 1 mcg/kg IV (instead of 100 mcg for everyone), and the standardization of postoperative analgesia (noted below). The total amount of fentanyl, propofol, and postoperative drugs will be recorded.

Postoperative analgesia will be standardized based on the subject's self reported verbal analogue score (VAS) and the timing of the report. The agents and timing used below differ from the current clinical standard by assessing VAS and responding with a certain regimen.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) I to III health status (moderate systemic disease),
* Age between 18 and 50 yrs
* Undergoing oocyte retrieval with intravenous general anesthesia.

Exclusion Criteria:

* Refuse or withdraw their consent
* Fail to adequately respond to IVF stimulations medications, and thus are not eligible for oocyte retrieval.
Predictive Biomarkers in Patients With Advanced Hepatocellular Carcinoma Treated With Systemic Therapy

Hepatocellular carcinoma (HCC) is the third most common cause of cancer-related deaths worldwide, and HCC is more frequently observed in Asia, including South Korea. As HCC is often accompanied by chronic hepatitis B or C virus and liver cirrhosis, treatment of HCC consider not only the tumor but also various factors such as liver function and the patient's performance status. Local treatment and surgery are possible in the early stages of HCC. However, it has a high recurrence rate even after curative surgeries due to underlying cirrhosis and the tumor microenvironment.

Although several studies have investigated gene mutations and differences in treatment response in advanced HCC through next-generation sequencing (NGS), studies on transcriptome analysis of advanced HCC through RNA-sequencing are hard to find, with a need for future research into precise classification and clinical significance of HCC based on multi-omics data.

to establish multi-omics data and discover biomarkers highly associated with treatment response in HCC patients

Eligibility Criteria:
Inclusion Criteria:

* Those above the age of 20 who understand the purpose of the study and agree to participate in the collection of samples during the study.
* Patients who have been diagnosed with unresectable advanced HCC through imaging, histological, or cytological tests.
* Patients who underwent an NGS test with advanced HCC tissues
* Patients who are scheduled to receive systemic treatment
* Patients with measurable lesions based on RECIST v1.1
* ECOG performance status 0 or 1
* Patients with a life expectancy of at least three months

Exclusion Criteria:

* Patients who have systemic conditions accompanied by instability of vital signs, such as infections or organ failure
* Those with mental/neurological conditions or dementia who have difficulties understanding and completing the consent form
* Those who are assessed as not suitable for this study, at the discretion of the researcher
Kristalose as Bowel Evacuant Prior to Colonoscopy

To determine whether Kristalose causes a significant increase in hydrogen and/or methane gas levels in patients requiring bowel evacuation, and also to determine the safety, efficacy, and patient preference of Kristalose as a bowel evacuant

This is a single center, open-label, pilot study to determine the safety, efficacy, and patient preference of Kristalose as a bowel evacuant prior to colonoscopy. Prior to colonoscopy, subjects will also undergo evaluation for the production of hydrogen and methane gases in the patient's gut (before and after receiving Kristalose) as assessed by a breath analysis instrument. Safety will be assessed by the occurrence of any treatment emergent adverse events. Efficacy will be determined by the endoscopist's rating of the cleanliness of the colon and the incidence of treatment failure (insufficient evacuation of the bowel).

Eligibility Criteria:
Inclusion Criteria:

Patients requiring bowel evacuation for colonoscopy

Exclusion Criteria:

1. Patients with galactosemia (galactose-sensitive diet).
2. Patients known to be hypersensitive to any of the components of Kristalose.
3. Patients with possible bowel obstruction, previous colonic surgery, gastric retention, bowel perforation, toxic colitis, toxic megacolon, or ileus.
4. Patients less than 18 years of age.
5. Inability to understand the requirements of the study or be unwilling to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board \[IRB\]) and agree to abide by the study restrictions.
6. Be pregnant or nursing
7. Be otherwise unsuitable for the study, in the opinion of the Investigator
Utility of Exercise-induced N-terminal (NT) Pro-brain Natriuretic Peptide Levels in Predicting Prognosis in Asymptomatic Aortic Stenosis

One hundred patients with moderate to severe asymptomatic aortic stenosis (AS) will be asked to exercise on a treadmill. NT-pro-BNP levels will be drawn before and after exercise. Changes in NT-pro-BNP levels will be correlated to outcomes at one year. In the pilot phase an additional 10 control subjects without AS will be enrolled to document the control response of NT-pro-BNP elevations with exercise.


Eligibility Criteria:
Inclusion Criteria:

1. valvular AS (Doppler velocity ≥ 3.0 m/s)
2. no baseline symptoms referable to valvular heart disease
3. able to perform ETT

Exclusion Criteria:

1. more than mild aortic regurgitation, mitral regurgitation/ stenosis, or tricuspid regurgitation/stenosis
2. previous AVR
3. known coronary artery disease
4. creatinine clearance 50 mL/min
5. LVEF \< 50%
6. planned valve surgery prior to enrollment
7. significant pulmonary disease
8. unable to give informed consent
9. pregnancy
Gene Expression in Monocytes of Growth Hormone Deficient Children

The Growth hormone (GH) is mainly synthesized in the anterior portion of the pituitary gland and has an effect on different body areas. Secreted in the circulatory stream, growth hormone reaches the liver and here stimulates the secretion of somatomedin C better known as insulin-like growth factor 1 (IGF), which constitutes its main anabolic effector.

Growth hormone deficiency (GHD) is characterized by a delay in the statural growth in children and is correlated with a worsening of body composition, cognitive functions, lipid metabolism, bone mineralization, cardiac performance and exercise in adults. Recombinant GH (rhGH) replacement therapy can correct these alterations and therefore improve the quality of life in treated patients, and accelerate growth in children.

The optimal dosage of rhGH varies for each patient, as the response to treatment suffers from considerable inter-individual variability. To date, IGF1 is the only available biomarker whose plasma levels correlate with replacement therapy.

It is important to underline how somatomedin C does not provide information about the optimal posology of rhGH for each patient in order, therefore, to predict its adverse events and efficacy.

In addition, it has been shown that the effects mediated by the somatotropic hormone on some tissues are direct, therefore independent of the action of IGF1, whose plasma levels are not, in this case, predictive of therapeutic response.

For this reason, it is therefore necessary to identify a more specific biomarker capable of monitoring the efficacy, individual responsiveness and any adverse events in patients receiving somatotropic hormone.

The GH receptor (GHR) is expressed in several cells, including monocytes. It is therefore possible that the response of monocytes to the somatotropic hormone partially mirrors that of the chondrocyte and other cell types. Given the difficulty of obtaining osteomuscular biopsies or specific body areas in which GH mediates its biological action, the published works have identified the specific cell line in which to study the molecular effects of the hormone in monocytes, thanks to their easy accessibility and high number of GHR.

In consideration of this, the investigators propose to stimulate monocytes of healthy and GHD children in vitro with rhGH and through next generation sequencing to identify the characteristic gene expression profile. The GH responsive genes identified with this study can be used for correlation studies on the response to rhGH treatment.


Eligibility Criteria:
Inclusion Criteria:

* Height lower the 3th percentile

Exclusion Criteria:

* Any endocrinopathy
* Liver, kidney or haemolymphopoietic system disorders
* Celiac disease or other chronic malabsorption conditions
* Genetic syndromes (such as Turner's S., Cystic fibrosis or Down S.)
* Drug therapies interfering with growth
Repetitive Transcranial Magnetic Stimulation (rTMS) as an add-on Treatment for Resistant Obsessive-compulsive Symptoms in Patients With Schizophrenia

This is a study to evaluate the efficacy of rTMS for relief of obsessive-compulsive symptoms in patients with schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Schizophrenia (DSM-IV-TR)
* YBOCS ≥ 16

Exclusion Criteria:

* Mental Retardation
* Substance abuse
* Any contraindication to rTMS
Intra-hepatic Chemotherapy in Patient With Non-resectable Liver Metastases From Cholangiocarcinoma

A phase II trial evaluating intra-hepatic chemotherapy with oxaliplatin every second week in combination with systemic gemcitabine and capecitabine in combination with cetuximab in patient with non-resectable liver metastases from cholangiocarcinoma.


Eligibility Criteria:
Inclusion Criteria:• Informed consent

* Age \> 18 years
* Performance status 0-1; expected survival ≥ 3 months
* Patient with histologically or cytologically adenocarcinoma developed from cells in the gall bladder, extra- or intrahepatic bile ducts or malignant cells consistent with above mentioned and radiologic findings consistent with cholangiocarcinoma
* Liver metastases not suitable for surgery or other local treatment
* Extrahepatic disease should be excluded by PET-CT-scan.
* Prior treatment with chemotherapy or no progression on first line treatment
* Metastases \< 70 % of the liver
* neutrophile granulocytes ≥ 1.5 x 109/l og thrombocytes ≥ 100 x 109/l
* bilirubin \< 2.0 x UNL (upper normal limit).
* creatinine-clearance ≥ 30 ml/min.
* INR \< 2.
* Intrahepatic treatment can be accomplished
* The patients is approved by a multidisciplinary team

Exclusion Criteria:• Other current or prior malignant disease except adequately treated and cured carcinoma in situ of the cervix or squamous cell carcinoma of the skin.

* Cytotoxic or experimental treatment within a 14 days period before start of trial medication
* The patient is not allowed to participate in other clinical trials.
* Any clinical symptoms suggesting peripheral neuropathy grade 2
* Other severe medical conditions
* Severe cardial disease or AMI \< 1 year
* Presence of diseases preventing oral therapy
* Patients with uncontrolled infection
* Pregnant or lactating women
* Women capable of childbearing not using a sufficient method of birth control
* Patients not able to understand the treatment or to collaborate
* Prior serious or unsuspected reaction after treatment with fluoropyrimidine
* Known prior hypersensitivity reactions to the agents
* Interstitial pneumonitis or pulmonary fibrosis
Impact of Peripheral Afferent Input on Central Neuropathic Pain

The overarching aim of this study is to investigate the contribution of peripheral afferent input to spontaneous and evoked central neuropathic pain after a spinal cord lesion or disease.

A key question that has been subject to longstanding debates in the field relates to the sites and mechanisms within the peripheral or central nervous system that potentially perpetuate chronic spontaneous and evoked central neuropathic pain. The investigators hypothesize that spontaneous central neuropathic pain depends on continuous, "physiological" somatosensory input from the painful body region in the periphery. Thus, spontaneous central neuropathic pain results from pathological gain control in central somatosensory networks with decreased activation thresholds for thermo- and mechanosensitive peripheral afferents.

Eligibility Criteria:
Inclusion Criteria:

* Definite central neuropathic pain according to current diagnostic algorithms involving at least both feet or both hands bilaterally and symmetrically with regard to the expected neuroanatomical distribution of the nerve block.
* Patients with spinal cord injury. For patients with pain in both legs, the injury has to be incomplete. For patients with pain in both arms, the injury can be complete or incomplete. The pain in the area that will be investigated (region of interest) has to be in an area with at least some preservation of sensation
* An intensity of spontaneous pain of ≥4 NRS \[0-10\] in the region of interest during the screening visit and at the day of the intervention.
* Participant is able and willing to give informed consent.
* For female subjects of childbearing potential: A negative pregnancy test and either use of highly effective contraception or sexual abstinence

Exclusion Criteria:

* Conus/cauda involvement or evidence of peripheral neuropathic pain due to documented peripheral lesion.
* Other known neurological and psychiatric conditions
* History or symptoms of significant diseases that may confound the measurements or represent contra-indications for the intervention (e.g., neuropathy following cancer or metabolic diseases such as diabetes mellitus, liver diseases, and kidney diseases.
* Cardiovascular diseases that preclude the anaesthetic intervention (e.g., arrythmias).
* Concomitant nociceptive pain within the innervation territory of the planned nerve block.
* Unable to understand and speak Danish
* Changes in pain medication within the last 4 weeks prior to the intervention.
* Treatment with warfarin or other blood thinning medications, that contraindicates regional anesthesia if the treating physician cannot recommend that such treatments are paused for at least 7 days before the study day
* Infection or skin disease in planned injection area
* Allergy for local anesthetics
* Pregnancy or lactation.
* Alcohol or drug abuse
* Pain intensity below 4 in the region of interest at the baseline measurement before the nerve block
Research Interest Antiphospholipid in Predicting Embolic Risk During Infective Endocarditis

EMBOL-EI (Research Interest antiphospholipid antibody for embolic risk prediction in infective endocarditis) is a prospective cohort study with a biological collection.

The main objective is: to re-evaluate the potential value of antiphospholipid (aPL) antibodies as predictors of embolic events in infective endocarditis (IE) in the light of the improved current knowledge on these aPL.

The seconds objectives are: Other plasma biomarkers of hemostasis (coagulation activation markers: D-dimer fragment 1 + 2 of prothrombin; endothelial biomarkers: plasma levels of von Willebrand factor) will be taken into account in the analysis, and interest in predicting embolic risk, alone or in combination with aPL will be investigated.

Criteria of inclusion

* Patient hospitalized in the University Hospital of Nancy with an Endocarditis some as modified Duke criteria by Li.

The patient is eligible if it is considered and treated as a case of infective endocarditis by physicians ensuring its management. The application of the diagnostic classification Duke criteria modified by Li is made after the collection of all the data at the output of the patient. Will be retained for the analysis of patients meeting certain infective endocarditis.

Clinical, microbiological data, derived from complementary therapies and scalable examinations (including the endpoint) were collected during the hospital stay by doctors that support helped a patient technician clinical studies. Each application is reviewed by a multidisciplinary panel of two experts for validation.

Once validated record, the data collection schedule is sent to the Centre d'Investigation Clinique 1433 Epidémiologie Clinique (CIC-EC) to be entered on a database.

A blood sample is taken from each patient at admission. These samples are packaged and stored in a collection. The serum used in search - called anticardiolipin (AC) Immunoglobulin G (IgG) and Immunoglobulin M (IgM) isotype by ELISA.

Eligibility Criteria:
Inclusion Criteria:

* All the patients admitted either in the Infectious Department, in the Cardiology Department or in the Intensive Care Unit of the University Hospital of Nancy and treated for IE.

Exclusion Criteria:

* Patients with a previously known aPL syndrome or illness frequently associated with aPL syndrome (such as lupus)
* Patients with a delay between blood sample and diagnosis of IE longer than 21days
* Patients who had no symptomatic embolic events and no imaging procedure to detect an asymptomatic embolic event