cyrilzakka/clinical-trials huggingface dataset:
Comparing the Diagnostic Accuracy of Clinical Dehydration Scales Among Small Children

The assessment of clinical dehydration scales diagnostic accuracy (CDS scale, WHO scale, Gorelick scale) among small children.

The eligible patient admitted to the hospital with acute diarrhea, after given written consent for participation in the study by the child's parents, will be clinically assessed. Dehydration syndromes noted by physician will be recorded in special form (in attachment). Than, the child will be weighted on a standard scale.

The next body mass evaluation will take place, when patient's clinical condition will by classified as good by the attending physician and the child will be at least 24 hours after finishing intravenous or probe rehydration therapy.

Eligibility Criteria:
Inclusion Criteria:

* age: 1 - 36 months for CDS scale; 1 month - 5 years old for WHO scale and Gorelick scale
* hospitalisation caused by acute diarrhea (acute diarrhea -increase in the frequency of evacuations ≥ 3 in 24 hours; with or without fever or vomiting)
* duration of symptoms under 5 days
* parents' written consent for child's participation in the study

Exclusion Criteria:

* Dehydration caused by other mechanisms than acute diarrhea, for example dehydration caused by:

  * acidosis
  * kidney failure
  * heart failure
  * chronic liver disease
  * respiratory failure
  * condition after surgery
Epidemiologic Study of Hepatocellular Carcinoma in the US

The purpose of this study is:

* to investigate the risk factors of HCC among Americans with focus on lifestyle factors and energy balance.
* to identify single nucleotide polymorphisms (SNPs) and haplotypes that are associated with HCC risk through a genome-wide search.
* to assess if genetic susceptibility differs by hepatitis virus infection or lifestyle factors, and to explore if there are interplays or effect modifications between genetic factors and viral infection or lifestyle factors.


Eligibility Criteria:
Inclusion Criteria for HCC cases:

* a diagnosis of primary liver cancer (excluding secondary tumors)
* a diagnosis of hepatocellular carcinoma if histology is available (excluding those diagnosed in intrahepatic bile duct, bile canals, biliary passages, canaliculi, gall duct and gallbladder)
* a diagnosis of hepatocellular carcinoma with or without microscopic evaluation (including those diagnosed with clinical evidence, lab tests and direct visualization or radiographic and other imaging evidence)
* a histology of primary hepatocellular carcinoma when the patients had a prior diagnosis of other forms of cancer (excluding those who had no histological diagnosis of hepatocellular carcinoma while having a prior history of other cancer;
* age at diagnosis between 35 and 84 years
* living in Connecticut, New Jersey, New York, or Hawaii for at least a year as regular residents.

Exclusion Criteria for HCC cases:

* uncertain diagnoses or classification of malignancy, such as unknown origin
* a diagnosis of primary tumors in other organs, not in the liver
* unable to communicate well enough in English or Spanish
* having medical conditions, such as mental disorders, that prevent the subject from providing reasonably comprehensible information or from being able to give informed consent.
* diagnosed at age \<35 years or \>84 years
* temporary residents of New Jersey, Connecticut, New York, or Hawaii

Inclusion Criteria for control subjects:

* age between 35 and 84 years
* living in New Jersey or Connecticut for at least a year as regular residents
* able to communicate well in English or Spanish
* having no medical conditions, such as mental disorders, that prevent them from providing adequately comprehensible information
* potential subjects with a previous history of cancer are eligible.

Exclusion Criteria for control subjects:

* age \< 35 years or \> 84 years
* temporary residents of New Jersey or Connecticut
* unable to speak English or Spanish
* cannot provide adequately comprehensible information
Transplantation of Pancreatic Islets in Patients With Type 1 Diabetes Mellitus and Functional Kidney Graft

This research project is supported by a multicentric network of collaborators whose goal is to assess the efficacy of transplanting allogenic pancreas islets to restore insulin secretion in patients with type 1, insulin-dependent diabetes mellitus with kidney transplantation and to improve their metabolic control.

The main objective is to demonstrate the beneficial effect of islet allotransplantation in patients with type 1 diabetes with no endogenous insulin secretion, and with a functional kidney graft. The other objectives are to evaluate the conditions for the efficacy of islet cell transplantation, to assess the improvement in quality of life and the cost of the islet cell transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes mellitus
* Disease duration \> 5 years
* ketose antecedents
* Basal and stimulated plasma C-\< 0.2 ng/ml,\<0.06 nmol/l (glycemia must be measured simultaneously_ 1.20 g/l or 6.6 mM, stimulation with glucagon IV 1 mg -Measured at à T0 and T 6 min)
* Established kidney graft ≥ 6 months
* Current creatinine clearance: ≥ 50 ml/min/1.73 m² and Proteinuria \< 0.5 g/24h
* HbA1C\< 12%

Exclusion Criteria:

* Hemostasis problems
* Documented hepatic pathology
* Patient under 18 or over 65 year-old
* Women with body weight over 70 kg (tolerance of 2 kg between inclusion day and transplantation day) or BMI \> 26
* Men with body weight \> 75 kg (tolerance of 3 kg between inclusion day and transplantation day) or BMI \> 26
* insuline needs \> 0.7 U/kg/j or 50 U/j
* Serious life-threatening pathology
* untreated hyperlipidemia
* Hypersensitivity to drugs rapamycine-alike
* Liver disease (transaminases or total bilirubin ≥ 3N)
* Failure to communicate or cooperate with the investigator

Exclusion criteria that are specific to the use of Rapamycine

* Hypercholesterolemia (\> 350mg/dl, 9,1 mmol/l) not controlled
* Hypertriglyceridemia (\> 500 mg/dl, 5,6 mmol/l) not controlled
* Leukocytes \> 4500 /mm3 , neutrophils \> 2000/ mm3, platelets \> 100000/ mm3
* Any clinical or biological pathology that could interfere with the study
* Past or present neoplasia (with the exception of non melanoma skin cancers)
* Any hemostasis disorder needing a prolonged treatment with anticoagulation drugs. Low-dose aspirin is permitted.
* Pregnancy, lactation, pregnancy project or absence of efficient contraception
* Any medical or psychosocial condition susceptible to interfere with the study, such as drug abuse or recent alcohol abuse
Comparison of Daily Mometasone Furoate Nasal Spray Alone Versus a Combination With Montelukast for Treatment of Chronic Rhinosinusitis With Asthma After Functional Endoscopic Sinus Surgery

1. objectives. To compare the efficacy and the safety of mometasone furoate nasal spray (MFNS; Nasonex 200μg, daily) alone versus a combination with montelukast (singulair 10mg, daily) in chronic rhinosinusitis (CRS) with asthma after functional endoscopic sinus surgery (FESS) for improvement the clinical control of CRS
2. the clinical hypotheses. The investigators hypothesize that postoperative combined montelukast and MFNS can better improve clinical control of CRS concomitant with asthma after FESS compared with MFNS alone.
3. study design This study is a 9-month randomized, open-label, controlled interventional study.

1. Surgery plan

   * Pre-operation: Patients enrolled in the study will complete assessment and specimen collection on the first day, then followed by 1 week drug therapy with prednisone (30 mg once daily) and MFNS(200ug, once daily).
   * FESS: For patients with no surgical contraindications, FESS will be performed. Bilateral nasal cavities will be filled with swelling sponges postoperatively. The stuffing will be removed on postoperative day 2. The patients will be discharged on day 3 after surgery.
   * Other treatment: All patients will receive nasal irrigation (normal saline 500 mg twice daily) from postoperative day 3 until day 30. Asthma will be treated as the guidance of professors from the Department of Respiratory Medicine in the investigators hospital.
2. Drug treatment phase Three days after the surgery (FESS) described above, all patients will be assigned to the following two groups (30 patients each group) using random numbers generated by statistical software.

   * Experimental group: Montelukast (10mg, once daily) and MFNS (200μg, once daily) for 6 months
   * Control group: MFNS (200μg, once daily) for 6 months
3. Follow up After the 6-month drug treatment phase, there are still a 3-month follow-up. Totally, there are 5 visits after FESS surgery.

   * Visit 1: baseline
   * Visit 2： Day 31 post-FESS
   * Visit 3: Day 61 post-FESS
   * Visit 4: Day 91 post-FESS
   * Visit 5: Day 181 post-FESS
   * Visit 6: Day 271 post-FESS

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of chronic rhinosinusitis according to European position paper of rhinosinusitis and nasal polyps 2007
2. Diagnosis of asthma based on Global initiative for asthma 2012
3. All patients should provide informed consent prior to the study and agree to follow-up appointments.

Exclusion Criteria:

1. Immunodeficiency diseases, history of head and/or facial trauma, cancer or organ transplant recipients.
2. Pregnancy or lactation.
3. Uncontrolled bronchial asthma.
4. Acute respiratory tract infection within one month before the study.
5. Use of leukotriene receptor antagonist within 3 months before the enrollment.
Clinical Outcomes Following Transcutaneous Auricular Neurostimulation to Improve Relapse Prevention: A Long-term Follow-up Study

This is a prospective, observational, longitudinal study to assess clinical outcomes in the 12-months following participants' exit from protocol SBM-OWP-03, Delivering Transcutaneous Auricular Neurostimulation to Improve Relapse Prevention in Opioid Use Disorder (RESTORE; ClinicalTrials.gov Identifier: NCT05053503). Clinical outcome scores will be collected at study exit from protocol SBM-OWP-03, 1 month, 3 months, 6 months, 9 months, and 12 months after study exit from protocol SBM-OWP-03.


Eligibility Criteria:
Inclusion Criteria:

1. Consented participant for protocol SBM-OWP-03, Delivering Transcutaneous Auricular Neurostimulation to Improve Relapse Prevention in Opioid Use Disorder (RESTORE)
2. Participant is English proficient
3. Participant is able to provide informed consent and function at an intellectual level sufficient for study requirements

Exclusion Criteria:

1. Participant is unable to reliably receive and respond to assessments via email or telephone
2. Participant has any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial
Evaluation of Long-term Quality of Life in Children Supported with ExtraCorporeal Membrane Oxygenation (ECMO)

The main objective of this prospective transversal comparative study is to describe the quality of life of children supported by ECMO. These patients are described in detail at the Nantes University Hospital, in particular the elements of neurological monitoring. These results will be analyzed in reference to a population hospitalized at the same age, in the same period, and sharing the same diagnostic categories.


Eligibility Criteria:
Inclusion Criteria:

* Patients accepted in pediatric intensive care at the Nantes University Hospital between January 2014 and December 2022
* Patients less than 10 years old at admission to the intensive care unit,
* Patients older than 2 years at the time of the cross-sectional evaluation
* For the ECMO group: Patients supported by ECMO
* For the control group: Patient intubated-ventilated for more than 48 hours and/or having received amines and/or having received organ support other than ECMO.
* Patient affiliated to the Social Security.
* Patient with parents who do not object to the study

Exclusion Criteria:

* Known genetic pathology or malformative association at the time of admission to the intensive care unit that could lead to severe neurodevelopmental deficits, independently of the medical events that resulted in the admission to the intensive care unit
* Language difficulty that does not allow for complete information and questionnaire collection
Coxsackie Virus in Pregnancy and Congenital Heart Disease

Investigators would like to find out if a woman's exposure to Coxsackievirus has an effect or increase in incidence of babies being born with congenital heart disease(CHD)

The investigator proposes that Coxsackievirus group B (CVB) infection in early pregnancy induces pathological changes in congenital heart defects. To test the hypothesis, it will be determined if the incidence of CVB infection in women with babies that are congenital heart defect-(CHD) affected pregnancies are higher than in control subjects.

After informed consent participants will provide the following samples during one study visit: 10 mL (about 2 teaspoons) blood draw, a nose swab, provide a stool specimen (or have a rectal swab) and complete a study questionnaire Our 3 study groups are the following-Group 1 is Hypoplastic Left Heart Syndrome or HLHS effected pregnancies. Group 2 is OCHD- Other Congenital Heart Defects and Group 3 is Unaffected Controls (UC) also known as healthy controls.

After informed consent participants will provide the following samples: 10 mL (about 2 teaspoons) blood draw, a nose swab, provide a stool specimen (or have a rectal swab).

A health history review and questionnaire will also be obtained.

Analysis of these samples(blood, stool and nose secretions), a medical history review and questionnaire data will help to determine if there is a link or increased risk of those who may be exposed to virus.

Note- Prior to April 2016- the protocol and the healthy control (HC)subjects group were enrolled to come in for three study visits at varying times in their pregnancy. Blood, nose and stool samples were obtained at all three visits.

Eligibility Criteria:
Inclusion Criteria

* Fetal echocardiogram demonstrating one of the following: Hypoplastic Left Heart Syndrome (HLHS) or variant, other congenital heart disease (OCHD), or unaffected control (UC)
* Gestation is ≥20 wks-fetal group (HLHS, OCHD)
* Subject is able and willing to give informed consent.

Exclusion Criteria

* Subject is \< 18 years of age.
* Subject is pregnant with twins or multiple gestations.
* Subject's pregnancy is affected by 3 or more congenital anomalies (in addition to the heart defect).
* Subject's pregnancy is affected by chromosomal anomalies (OCHD \& UC groups)
* Maternal history of chromosomal anomaly (OCHD \& UC groups)
* Infertility treatment for current/index pregnancy
Primed vs Unprimed Facilitatory and Depressive Paired Associative Stimulation

Following brain injury (e.g. stroke), application of non-invasive brain stimulation may improve rehabilitative efforts. However, the most effective method of non-invasive brain stimulation is unknown. Paired associative stimulation (PAS) is a method of non-invasive brain stimulation that pairs an electrical peripheral nerve stimulus with a magnetic stimulus to the head. This method can be applied in a manner that increases (facilitates) or decreases (depresses) excitability within the brain. Furthermore, applying two consecutive PAS sessions within minutes of each other (called primed PAS) may augment changes in excitability more than a single PAS session alone.

Thus, the purpose of this study is to compare the effect of a double PAS session (primed PAS) to the effect of a single PAS session (unprimed PAS) and a sham PAS session in healthy individuals.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 and ≤ 30 years of age
* Elicitable motor evoked potential from the motor cortex contralateral to the dominant hand
* Elicitable N20 sensory evoked potential

Exclusion Criteria:

* History of neurological disease
* Seizure within the past 2 years
* Currently taking epileptogenic medication
* Peripheral neuropathy
* Cognitive impairment and/or major psychiatric disorder
* Metal in the head (dental permitted)
* Pacemaker or other indwelling devices
* Pregnancy
Planned Vaginal Delivery vs Planned Cesarean Delivery in Preterm Twins

The incidence of twin pregnancies has increased and currently accounts for 1.8% of all deliveries. 47.5% of twins are born prematurely (vs. 6% for singletons) of which 9.9% before 32SA. Caesarean section rates are also higher than for singletons (53.7% vs 19.2%) and 31.8% of caesarean sections are performed before delivery.

The optimal mode of delivery for preterm twins remains controversial. The latest recommendations for clinical practice emphasize that it is not appropriate to recommend one mode of delivery rather than another in the case of twin pregnancies at any term.

In view of all these elements, we wished to carry out a retrospective study at the Montpellier University Hospital in order to compare the neonatal outcome of preterms twins according to their mode of delivery : planned vaginal delivery versus planned cesarean delivery.


Eligibility Criteria:
Inclusion criteria:

* twins born at Montpellier University Hospital
* between 24SA and 32SA+6
* January 2010 to July 2019
* The mothers must have gone into labour spontaneously or after preterm rupture of membranes
* first twin in cephalic presentation

Exclusion criteria:

* twin to twin transfusion syndrome
* monoamniotic pregnancies
* cause of delivery other than preterm labor or preterm rupture of membranes
* lethal malformation
* first twin in breech or transverse presentation
The Roshni Project - Developing a Psychosocial Intervention

The mental health sector is being called upon to develop and implement interventions for youth that attend to gender, age and cultural diversity (Mental Health Commission of Canada, 2016). The proposed project outlines the development and feasibility testing of a culturally driven transdiagnostic psychosocial intervention for South Asian women aged 16-24 years. We will recruit 30 participants to complete the 12 week psychosocial intervention. Pre, midpoint and post evaluations will be completed to asses change in mental health, self esteem and values, and also qualitative feedback on participant experiences of the intervention.


Eligibility Criteria:
Inclusion criteria:

* aged 16-24 years
* identify as a woman
* ancestry connected to India, Pakistan, Bangladesh and Sri Lanka
* formal diagnosis of mood or anxiety disorder
* completed high-school in Canada
* reside in the Greater Toronto Area
* speak conversational English

Exclusion criteria:

• individuals with developmental disabilities and serious mental illness e.g. schizophrenia spectrum, bipolar and personality disorders.
Biomarkers of Efficacy and Tolerability of Sacituzumab-Govitecan in the Treatment of Patients With Triple-negative Breast Cancer in the Metastatic Phase: Prospective Multicenter Real-world Study

Observational, prospective, multicenter study. Collection of data relating to the effectiveness of sacituzumab govitecan SG, in a real-world context and planned research of predictive biomarkers of efficacy/tolerability carried out on multiple platforms at the center coordinator.

Identification and inclusion in the study of patients affected by metastatic triple-negative breast cancer mTNBC, treated with sacituzumab govitecan SG as indicated at the participating centers.

Histological and biomolecular characteristics will be evaluated both on the tumor at diagnosis and on tissue resulting from biopsy of the metastatic site, where available. Otherwise, the analyzes will come anyway carried out on the most recent and available tumor tissue, whether deriving from primary tumor or site metastatic.

The search for biomarkers predictive of efficacy/tolerability will be carried out on tumor tissue (where possible both primary and metastatic) and on circulating plasma collected at two separate time points (T0 and T1).

Biomolecular characterization on the biological material of the enrolled patients (tumor tissue and plasma) will be carried out at the end of the study.

The feasibility of organoid development and single-cell sequencing will be evaluated on a small subgroup of patients, among those enrolled at the coordinating center, considering the need for tumor tissue prepared fresh for both methods.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years;
* Histological diagnosis of TNBC;
* Locally advanced unresectable or metastatic disease;
* Indication for treatment with SG in monotherapy according to clinical practice (patients pre-treated with at least two lines of systemic therapy, of which at least one in an advanced stage);
* Availability of at least one tumor tissue sample (from primary tumor or metastasis) to be sent to the coordinating center (IRE);
* Written informed consent;
* Availability to comply with the procedures established by the protocol, according to the methods and times described.

Exclusion Criteria:

* Patients with a history of other malignancies;
* Contraindications to the use of sacituzumab govitecan SG;
* Untreated and/or clinically unstable (symptomatic) brain metastases.
A Phase 1 Study of OCV-C02 in Patients With Advanced or Relapsed Colorectal Cancer

To assess the safety and tolerability of OCV-C02 in Patients With Advanced or Relapsed Colorectal Cancer Who Are Refractory or Intolerant to Standard Chemotherapy

The incidence of dose limiting toxicity (DLT) will be evaluated in cohorts of six patients by starting OCV-C02 administration at dose level 1 (OCV-103 and OCV-104 at 0.3 mg each), increasing the dose to dose level 2 (at 1 mg each), level 3 (at 3 mg each), and then up to dose level 4 (at 6 mg each). Once-weekly administration will be repeated four times in each treatment cycle, and the incidence of DLT from Day 1 to Day 29 will be evaluated.

At the end of Cycle 1, patients who wish to continue OCV-C02 treatment and have provided their written consent will be permitted to continue participation in the trial using the same dosing schedule for each subsequent cycle as that for Cycle 1.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have human leukocyte antigen (HLA)-A\*24:02
* Patients who have histologically-confirmed colorectal cancer (adenocarcinoma)
* Patients with advanced or relapsed colorectal cancer who are refractory or intolerant to standard chemotherapy
* Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1 at the time of enrollment in the trial.

Exclusion Criteria:

* Patients who are HIV antibody test positive
* Patients with an active infection
* Patients who have or are suspected to have CNS metastasis of colon cancer (such as metastatis of the brain)
Interpretations and Predictions of Patient Reported Outcomes by Breast Cancer Patients

This study will assess how patients' long-term quality of life after different surgical approaches compares to their predicted quality of life.

This study will assess how patients' long-term quality of life after different surgical approaches compares to their predicted quality of life. It will also provide the research team with improved understanding of how patients interact with and prefer to receive QOL information. Improved understanding of patient predictions and perceptions of information display will allow us to incorporate predicted future PROs into the shared decision making process as well as allow us to provide this important information to patients in a meaningful way.

Eligibility Criteria:
Inclusion Criteria:

* Pre-surgical female breast cancer patients
* Female breast cancer survivors

Exclusion Criteria:

-