cyrilzakka/clinical-trials huggingface dataset:
The Investigation of Children With Developmental Delay and Children's Rehabilitation Common Case

Children with developmental disabilities and children's rehabilitation common case investigation: Long-term follow-up study.

Three fundamental goals of early rehabilitation for children with DD are: optimizing body function within each child's prognostic potential, preventing the development of secondary conditions that impact life-long health, and promoting children's participation in their lives. Knowledge of these developmental patterns of FPLA may be helpful in understanding, anticipating, and managing the problems of these patients. The investigators hypothesize that the course of developmental patterns in Function and Participation in Life Activities (FPLA) of patients with DD evolves with their age. The levels of functional recovery included developmental function, activity, participation, and quality of life (QOL). The aim of this study is to investigate the longitudinal outcomes in patients with DD evaluated by developmental function, activity, participation, and QOL. Additionally, the predictors in the initial stage in determining the final developmental patterns in FPLA of these children will be identified.

Eligibility Criteria:
Inclusion Criteria:

1. Children with aged 0-20 years
2. Control group: Children with orthopedic disease, Experimental group: Children with Developmental disabilities

Exclusion Criteria:

1. Low cooperative with follow-up
2. Low cooperative with clinical assessment
3. Low cooperative with questionnaire writing and data collection
Baby Observational and Nutritional Study

Cystic fibrosis (CF) is a life-shortening disease that causes breathing and digestive problems, but can now be diagnosed at the time of birth. Lung function is very hard to measure in infants, but growth is not. In this study the investigators aim to define growth in infants with CF in the first year of life with research quality precision and to understand factors that interfere with good growth.

Pancreatic enzyme replacement therapy (PERT) will be also be studied in a subgroup of infants. Two different doses of PERT will be evaluated for improving fat and nitrogen absorption in infants with CF.

Newborn screening (NBS) for cystic fibrosis (CF) has decreased the prevalence of malnutrition in infancy, but suboptimal nutrition still persists. In one study, 60% of infants diagnosed by NBS achieved their birth weight percentile by two years of age, while 40% did not. The many factors that contribute to this poor growth have not been defined and persist despite pancreatic enzyme supplementation. Although published guidelines for the clinical management of infants with cystic fibrosis in the U.S. and Europe exist, there is an alarming scarcity of evidence to dictate care. In order to proceed with large scale randomized studies to evaluate the range of interventions for infants with CF, we need to not only develop precise techniques for measuring growth but also pursue unexplored factors that may contribute to poor growth.

This is a multi-center observational clinical study with a nested interventional PERT sub-study. The observational study was designed to follow in a prospective manner incident cases of CF for up to 12 months. The PERT sub-study is a randomized, double-blind, crossover sub-study designed to evaluate the efficacy and safety of two doses of PERT (pancreatic enzyme replacement therapy) for improving coefficient of fat absorption (CFA) in the stool of infants with CF. The PERT sub-study was unable to enroll and closed. No results available.

Eligibility Criteria:
Observational Study

Inclusion Criteria:

1. Signed informed consent
2. Males or females no more than three and one half (3.5) months of age at enrollment
3. Documentation of a CF diagnosis as evidenced by:

   1. One or more of the following: one or more clinical features consistent with the CF phenotype OR a positive newborn screening (NBS) OR a positive pre-natal screen

      AND
   2. One or more of the following: sweat chloride ≥ 60 mEq/liter by quantitative pilocarpine iontophoresis test (QPIT) OR two well-characterized mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene
4. Enrolled in the Cystic Fibrosis Foundation Patient Registry. (Patients may enroll in the Registry at Enrollment Visit if not previously enrolled.)

Exclusion Criteria:

1. Children unable to take full oral feeds
2. Any serious or active medical condition, which in the opinion of the investigator, contributes to malabsorption, interferes with normal growth, or would otherwise interfere with subject's treatment, assessment, or compliance with the protocol.
3. Gestational age less than 35 weeks and/or birth weight \< 2.5 kg.
Peritonsillar Infiltration With Levobupivacaine for Posttonsillectomy Pain

The investigators aimed to evaluate the effects of different concentrations of preincisional peritonsillar levobupivacaine (0.25% ve 0.5%) on postoperative pain and bleeding

72 ASA I-II patients between 3 and 12 years of age who scheduled to undergo tonsillectomy were enrolled in this randomized, prospective and placebo-controlled study. The indications for tonsillectomy were recurrent infections and tonsillar hypertrophy leading to obstructive symptoms.

The patients included to the study were randomly assigned to one of the 3 groups to receive different concentrations of levobupivacaine or saline.

The mean arterial pressure (MAP) and heart rates (HR) of all patients were recorded during the whole anesthesia and surgical procedures. The duration of anesthesia and surgery were also recorded. Additional remifentanil 1 µgr kg-1 IV was administered to the patients if HR was increased by 25 % of the basal value.

During postoperative period, symptoms such as pain, fever and dysphagia, adverse affects such as nausea and vomiting and hemorrhage were evaluated. Pain was evaluated by FLACC (Faces, leg, activity, cry, consolability), FPRS (Faces pain rating scale) ve Wong-Baker facies scales at postoperative 0, 30 and 60 minutes and 2, 6, 12 and 24 hours. Total analgesic consumption during the postoperative period were recorded. If the patients had no complication, they were discharged at the postoperative 24th hour.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 3 and 12 who were scheduled to undergo tonsillectomy due to recurrent infections leading to obstructive symptoms
* Patients aged 3 and 12 who were scheduled to undergo tonsillectomy due to tonsillar hypertrophy leading to obstructive symptoms.

Exclusion Criteria:

* Hypersensitivity to sevoflurane, benzodiazepine, fentanyl analogues, propofol and components, paracetamol, levobupivacaine
* Presence of coagulation disorders and chronic diseases
* Presence of regular use of analgesics
* Presence of analgesic use within 24 hours prior to surgery
* Presence of upper respiratory system infection
* Inability to understand the pain scales, being unable to communicate.
Supporting Tools and Cognitive Aids for BLS

Various studies have shown that rapid and correctly performed cardiopulmonary resuscitation (CPR) significantly increases the survival rate after cardiac arrest. Such a situation can affect anyone, anywhere and at any time, making it all the more important to master the basic skills and abilities of Basic Life Support (BLS). Thanks to constant technical progress, there are now numerous digital tools in the field of lay resuscitation. There are also feedback devices for CPR for laypersons, the use of which is currently the subject of scientific debate. In order to evaluate the influence of various tools on the quality of lay resuscitation, we are planning a prospective, randomized study in a parallel group design. This study is aimed at medical laypersons between the ages of 18 and 70 who have completed a BLS course (e.g. first aid course for driver\&#39;s license) within the last 10 years. All participants are asked to take part in a mannequin-based simulation scenario in a public place. As part of this simulation scenario, the BLS algorithm is to be performed (recognizing respiratory-circulatory arrest, calling for help, performing chest compressions, organizing a defibrillator). After performing the 1-minute cardiac massage, the scenario is ended. We plan to randomize into 3 groups. Group 1 will receive paper-based information material on how to perform BLS correctly. Group 2 will receive a first aid app. Group 3 will receive a small medical device (CorPatch®), which gives direct feedback on the quality of chest compressions (e.g. frequency, depth), including an accompanying app for support. The time to blood flow (defined as the succession of 5 sufficient chest compressions in this study) will be evaluated as the primary outcome. Secondarily, resuscitation management will be evaluated using a validated BLS checklist, the time to critical actions (such as time to alert the emergency services), the quality of CPR, the cognitive load of the participants and the user-friendliness of the assigned aid.


Eligibility Criteria:
Inclusion Criteria:

* 18-70 years
* First Aid Training within the last 10 years

Exclusion Criteria:

- medical student, physician, nurse, paramedic
Early COPD for China Pulmonary Health Study Stage II

Discovery of the pathogenesis and targets in the progression of early chronic obstructive pulmonary disease

This project is aimed to investigate and explore the heterogeneity during the progression of Chronic Obstructive Pulmonary Disease (COPD) in the early stage, utilizing the large-scale population cohort databases (including "China Pulmonary Health study", "The Cohort Study for Chronic Obstructive Pulmonary Disease in China" and "Acute Exacerbation of COPD Patient Registry in China" ), biological sample libraries(including blood, sputum, expiratory air, bronchoalveolar lavage fluid(BALF), and lung tissue from COPD patients with different stages and phenotypes), and multi-omics sequencing (including scRNA-seq, metabolomics, proteomics, and metagenome). We propose to establish a new standard for COPD stages and subtypes. By analyzing and mining the multi-omics data, it is expected to illustrate the association between clinical phenotype and molecular, cellular and tissue heterogeneities, thus reveal biomarkers related to the progression, clinical phenotypes, and prognosis of early-stage COPD disease.In addition, we will construct different types and stages of COPD animal models for further mechanism studies, such as the different pathogenic factors, innate and adaptive immunity, and the airway microbial ecosystem, so that we can discovered more potential therapeutic target for early-stage COPD. This project can bring a new insight and scientific evidence for COPD treatment.

Eligibility Criteria:
Inclusion Criteria:

* younger than 50 years
* smoking more than 10 pack-years
* early airflow limitation(post-bronchodilator FEV1/FVC\< lower limit of normal)

Exclusion Criteria:

* cancer
* other respiratory diseases
* mental illness
Time-restricted Eating and High Intensity Interval Training Among Women

This project will determine the independent and combined effects of high intensity interval training and time-restricted eating on blood sugar regulation among women in reproductive-age who have overweight or obesity. The intervention period will be seven weeks. Before and after the intervention, blood sugar regulation, body composition and physical fitness will be measured and compared between groups who are doing either high intensity interval training, time-restricted eating, both high intensity interval training and time-restricted eating, or who are in a control group. Physical activity, sleep quality, continuous glucose monitoring, adherence to the interventions and hunger/satiety will also be measured.

In a follow-up study, we will invite randomized participants to come in for new assessments of physical fitness, body composition and fasting blood samples, and they will be asked to complete questionnaires about adherence to the interventions two years after intervention-end. The first participants will come in to the laboratory for the two-year follow up in November 2021.

Eligibility Criteria:
Inclusion Criteria:

* body mass index ≥ 27 kg/cm2,
* able to walk on a treadmill or ride a bike for at least 60 min.

Exclusion Criteria:

* Pregnancy, lactation within 24 weeks of study commencement
* known cardiovascular disease
* type 1 or 2 diabetes
* currently taking hypertension or glucose- or lipid-lowering medication
* habitual eating window \< 12 hours
* performing high intensity training more than once a week
* body mass variations \> 4 kg three months prior to study commencement
* shift work that includes night shifts.
32 Week, Open, Randomized, 2 Way Cross Over Multicentre Trial to Compare Safety & Efficacy of Combination of HOE901 Insulin Analogue Once Daily at Bedtime + Lispro Insulin Before Meals vs NPH Insulin (Twice a Day) + Regular in Type 1 Diabetes Mellitus

To compare the efficacy (in terms of metabolic control evaluated through HbA1c levels) of treatment with insulin glargine as basal insulin and insulin analogue (insulin lispro) as mealtime insulin with a regimen of insulin NPH as basal insulin with regular insulin, as mealtime insulin, after a 16 week treatment phase with each regimen and to compare the safety of both treatments, evaluated through hypoglycemic rates.

Multicenter, open-label, randomized (allocation ratio 1:1), cross-over with two treatment phases of 16 weeks each in two treatment groups:

* Study arm with insulin glargine + insulin lispro (phase 1) and insulin NPH + regular insulin (phase 2)
* Insulin NPH + regular insulin (phase 1) and insulin glargine + insulin lispro (phase 2)

Eligibility Criteria:
Inclusion Criteria:

* Subjects with type 1 diabetes mellitus
* 18-65 years of age
* C-Peptide negative
* Treated at least for 6 months with multiple daily doses of insulin and with HbA1c greater than or equal to 7.0% and less than or equal to 9.5% and a BMI less than or equal to 35 kg/m².
* Women of childbearing potential must have a negative pregnancy test in visit 1 and must use an effective contraceptive method during the study.
Prognostic Value of Implementing VCE on Top in Constitutional VWD-patients With GI-bleeding

Inclusion criteria: Only constitutional VWD-patients fulfilling the inclusion criteria of the French reference center for VWD will be included. Patients with acquired von Willebrand syndrome will not be included.

Material and Methods: A 15-items survey that will be sent to the 30 centers involved in the French network for bleeding disorders (MHEMO) to identify VWD-patients referred for endoscopic exploration of at least one GI-bleeding from January 2015 to December 2017. Only constitutional VWD-patients fulfilling the inclusion criteria of the French reference center for VWD will be included. Constitutional VWD diagnosis will be confirmed confirmed centrally in all patients by the French reference center for von Willebrand disease. A GI-bleeding episode will be defined as any overt or occult GI-bleeding (unexplained chronic iron deficiency anemia causing a drop of hemoglobin level by more than 2 g/dL from baseline). We will analyze patient characteristics, GI-bleeding pattern, VWD type/subtype, nature (gastroscopy, colonoscopy or VCE) and results of the endoscopic exploration and management that was applied: endoscopic therapy by argon plasma coagulation, on-demand/prophylactic-VWF replacement therapy, use of antiangiogenic drugs. If angiodysplasia without another bleeding source is identified, GI-bleeding will be categorized as angiodysplasia, if another lesion is identified GI-bleeding will be categorized as "no-angiodysplasia" and if no bleeding source is identified, GI-bleeding will be categorized as obscure GI-bleeding. Recurrence will be defined as evidence of overt GI-bleeding or a drop of hemoglobin level by more than 2 g/dL from baseline.


Eligibility Criteria:
Inclusion Criteria:

- At least one overt or occult GI-bleeding (unexplained iron deficiency anemia causing a drop of hemoglobin level by more than 2g/dL from baseline) episode between January 1st 2015 and December 31th 2017

Exclusion Criteria:

* acquired Von Willebrand syndrome
Validation of Kinocardiography, New Technology for Cardiac Linear and Torsional Contractility Measurement, to Assess Heart Failure Patient With Low Ejection Fraction

Measuring cardiac contractility is commonly realized with gold standard echocardiography or MRI. Portable devices to measure this contractility are not available as for rhythm and electric function assessment. The new Kinocardiography technology could provide a non invasive and portable tool to measure contractility.

This device records the electric and mechanic function of the heart simultaneously. With electrodes and adequate electronics, ECG is recorded. 6 degrees of freedom accelerometers are also included in the device to measure the micro accelerations of the body at the body surface when the device is placed on the skin. Using physics principles and adequate calibration, those accelerations allow the investigators to calculate parameters such as kinetics energies related to cardiac contractility. Kinocardiography is a non invasive and portable technology.


Eligibility Criteria:
Inclusion Criteria:

* Control group: Left Ventricle Ejection Fraction ≥ 50 %
* Heart failure patients: Left Ventricle Ejection Fraction \< 50 %

Exclusion Criteria:

* Intracardiac devices and arrhythmia at the time of assessment
* Participates in other clinical study or trial.
Effects of IAP-EOGBSD on Maternal Vaginal Microbiome, Offspring's Gut Microbiome and Metabolites.

In view of the current status of prevention and research on GBS disease in mothers and infants at home and abroad, this project intends to explore the characteristics of vaginal microbiota of GBS-colonized pregnant women in southern China, the impact of IAP prevention of GBS-EOD on vaginal flora, and the effect of IAP prevention of GBS-EOD on intestinal flora and immune production in offspring, so as to improve the ability to prevent and treat GBS-related diseases in mothers and infants and promote maternal and infant health.

This project intends to explore the characteristics of vaginal microbiota of GBS-colonized pregnant women in southern China, the impact of IAP prevention of GBS-EOD on vaginal flora, and the effect of IAP prevention of GBS-EOD on intestinal flora and immune production in offspring, so as to improve the ability to prevent and treat GBS-related diseases in mothers and infants and promote maternal and infant health.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women are 18 to 40 years;
* 35 to 41 weeks of pregnancy;
* Singleton pregnancy;
* Plan for vaginal delivery and postpartum care in the research hospital;
* Pregnant women who volunteered to participate in the study.

Exclusion Criteria:

* Have infectious diseases, serious infections and clinical diseases;
* Use of antibiotics in the past 2 weeks;
* Long-term use of drugs due to digestion, immunity, blood, chronic diseases;
* Sexual behavior, vaginal douching and topical medication within 24 hours before sampling;
* Any medical or non-medical condition that the investigator considers inappropriate to participate.
A Study of Izalontamab Brengitecan Versus Chemotherapy in Participants With Previously Untreated, Locally Advanced, Recurrent Inoperable, or Metastatic Triple-negative Breast Cancer Ineligible for Anti-PD(L)1 Drugs (IZABRIGHT-Breast01)

The purpose of this study is to assess the efficacy and safety of iza-bren, a bi-specific antibody-drug conjugate against EGFR and HER3 with a topoisomerase inhibitor payload versus treatment of physician's choice (TPC) (paclitaxel, nab-paclitaxel, carboplatin plus gemcitabine, and capecitabine) for the treatment of first-line metastatic triple-negative breast cancer (TNBC) or estrogen receptor (ER)-low, human epidermal growth factor receptor 2 (HER2)-negative BC patients who are not candidates for anti-PD(L)1 therapy and endocrine therapies.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed and documented locally-advanced, recurrent inoperable, or metastatic TNBC (ER \< 1%, PgR \< 1%, HER2 IHC 0, 1+, or 2+ with FISH negative for HER2 gene amplification) or ER-low, HER2-negative BC (ER and / or PgR 1% to 10%, HER2 IHC 0, 1+, or 2+ with FISH negative for HER2 gene amplification) per ASCO/CAP criteria, based on the most recently analyzed biopsy or other pathology specimen.
* Patients with recurrent disease must have experienced disease relapse at least 6 months after finishing their last therapy with curative intent.
* Patients with TNBC must be considered ineligible for 1L chemotherapy combination treatment with an anti-PD-1 or an anti-PD-L1 due to either one of the following criteria:.
* Investigator-determined ineligibility based on PD-L1 negative disease determined and documented prior to trial screening as part of SoC.
* Has experienced disease relapse between 6 to 12 months after the completion of (neo)adjuvant therapy with an anti-PD(L)1.
* Has a severe auto-immune disease or other contraindication.
* Patients with ER-low, HER2-negative BC must be ineligible, in the opinion of the Investigator, for endocrine therapy-based treatments.
* No previous systemic therapy in the locally advanced, recurrent inoperable or metastatic setting (ie incurable setting).
* Measurable disease by CT or MRI as per RECIST v1.1.
* Other protocol-defined Inclusion/Exclusion criteria apply.
Study of Blood Samples From Patients With Osteosarcoma

This research trial studies blood samples from patients with osteosarcoma. Studying the genes found in samples of blood from patients with osteosarcoma may help doctors identify biomarkers related to the disease.

PRIMARY OBJECTIVE:

I. Conduct a large-scale candidate gene association study in osteosarcoma (OS) using cases from the national Children's Oncology Group (COG) OS biology study (P9851 and successor study AOST06B1).

SECONDARY OBJECTIVES:

I. Conduct a genome-wide association study (GWAS) of OS. II. Fine-map genomic regions associated with OS to identify putative functional loci.

III. Conduct whole-exome sequencing of germline OS deoxyribonucleic acid (DNA) samples.

IV. Investigate the functional implications of promising genetic variants associated with OS.

OUTLINE:

Blood samples undergo polymorphism analysis of common single-nucleotide polymorphisms and haplotypes to examine genetic variation, gene-gene interactions, and the population structure.

Eligibility Criteria:
Inclusion Criteria:

* Blood samples collected from clinical trials COG-P9851 and COG-AOST06B1