cyrilzakka/clinical-trials huggingface dataset:
MSCs Therapy for Cerebral Palsy

Cerebral palsy (CP) is the most common physical disability in childhood. CP comprises a heterogeneous group of disorders that are the result of a non-progressive disruption or injury that occurred during fetal brain development or within the first two years of life.

This disruption can result in spasticity, dystonia, muscle contractures, weakness and difficulty in coordination that ultimately affects the ability to control movements. Resultant activity limitations may affect gross motor movements, fine motor movements, speech and communication, as well as eating and drinking.

Eligibility Criteria:
Inclusion Criteria:

* • Must be more than 2 year of age and less than 12 years of age at the time of screening for inclusion in the study.

  * Clinical evidence of a non-progressive motor disability due to brain dysfunction.

Exclusion Criteria:

* • Intractable seizures

  * Traumatic brain injury
  * Genetic disorder
  * Current Infection
  * Renal insufficiency
  * Hepatic disease
  * HIV+ (as demonstrated by positive blood test)
  * Immunosuppression
Phase I/II Study of Curdlan Sulfate

To assess the safety and tolerance of curdlan sulfate, as well as its anti-HIV activity, in HIV-infected patients with CD4 T-lymphocytes less than 500 cells/mm3, using first single doses and then, after FDA review, daily doses for 7 days.

In Phase I of the study, escalating single doses of intravenous curdlan sulfate are tested. In Phase II, curdlan sulfate is administered daily for 7 days. (NOTE: Phase I is completed.)

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* HIV seropositivity.
* No current AIDS-defining opportunistic infection, lymphoma, Kaposi's sarcoma, or other malignancy.
* CD4 count \< 500 cells/mm3.
* No critical illness that would shorten life expectancy to \< 16 weeks.

Exclusion Criteria

Concurrent Medication:

Excluded:

* Antiretroviral or other experimental therapies.
* Anticoagulants.
* Steroids.
* Cytotoxic or immunosuppressive agents.

Concurrent Treatment:

Excluded:

* Radiotherapy.

Patients with the following prior condition are excluded:

History of heparin sensitivity.

Prior Medication:

Excluded within 1 month prior to study entry:

* Antiretroviral or other experimental therapies.
* Anticoagulants.
* Steroids.
* Cytotoxic or immunosuppressive agents.

Prior Treatment:

Excluded:

* Radiotherapy within 1 month prior to study entry. Active IV drug abuse.
Integration of VR and AR Dementia Prevention Health Education Progrom for Older Adults with Mild Cognitive Impairment

The goal of this randomized controlled trial is to evaluate the effectiveness of Virtual Reality (VR)-based cognitive health education in older adults with mild cognitive impairment (MCI) in Taiwan. The study aims to assess whether VR-enhanced interventions improve cognitive health knowledge, health literacy, and self-management abilities among participants.

The main research questions are:

1. Does the VR-based intervention improve participants' dementia-related knowledge and health literacy?
2. Does the VR-based intervention enhance cognitive function, mental well-being, and self-efficacy compared to a control group?

Participants will be randomly assigned to one of two groups:

1. Intervention group: Will receive the "VR Dementia Prevention Health Education Module," an immersive virtual reality program designed to improve dementia-related knowledge and coping strategies.
2. Control group: Will receive standard, routine health education without VR exposure.

This study is a randomized controlled trial (RCT) designed to assess the effectiveness of a Virtual Reality (VR)-based cognitive health education program for older adults in Taiwan who exhibit signs of mild cognitive impairment (MCI). The study aims to determine whether VR-enhanced dementia prevention education improves dementia-related knowledge, health literacy, self-efficacy, and acceptance of dementia compared to a control group receiving standard health education without VR exposure and intervention.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 65 years or older.
* AD-8 score ≥ 2, indicating potential cognitive impairment.
* Able to understand and follow basic instructions in Mandarin or Taiwanese.
* Capable of providing informed consent or has a legally authorized representative to provide consent.
* Able to tolerate and interact with VR equipment (e.g., wearing a VR headset, using hand controllers).

Exclusion Criteria:

* Diagnosed with moderate to severe dementia (i.e., unable to follow basic instructions).
* Presence of severe visual, auditory, or motor impairments that prevent interaction with VR devices.
* Diagnosed with severe psychiatric disorders (e.g., schizophrenia, major depressive disorder).
* Unable to communicate effectively in Mandarin or Taiwanese.
A Point-of-care Electrochemical-based Device for Rapid Detection of Fibrinogen on Type A Aortic Dissection Surgery

This study compares the results of the existing fibrinogen concentration monitoring technology to the Electrochemical-based device, a point-of-care and rapid method,using a small amount of extra blood obtained in Type A Aortic Dissection Surgery.

Electrochemical-based device for rapid detection of fibrinogen is a novel POC diagnostic method, which is suitable for operating theatres and emergency rooms.

The novel fibrinogen detection based on Gel electrodes combined with immunobiosensing strategies and use magnitude of current to characterize the fibrinogen concentration , which will be a POC assay of fibrinogen detection for critically ill patients.

This single-center, prospective, observational pilot study will evaluate the analytical performance as well as compared to conventional Clauss laboratory reference method.

Eligibility Criteria:
Part1 Phase I-Laboratory calibration. The electrochemical method was employed to detect the fibrinogen concentration of standard quality control materials with varying concentration gradients, and the corresponding current values were recorded for constructing a standard curve of fibrinogen concentration.

Phase II-Assay performance using clinical samples. Subject is 18 years and underwent routine hemostasis analysis. using human biological samples already collected for routine hemostasis analysis, The samples were centrifuged at 2500g for 15 min at room temperature, to obtain PPP (residual platelet count of \<10 × 10\^9/L) and stored at-20℃used for determination by electrochemical method within 2 weeks, Each clinical sample was tested three times

Part2

Inclusion Criteria:

Subject underwent surgery for acute type A aortic dissection at our hospital, Subject is 18 years, Subject requires routine TEG measurement, Subject use human fibrinogen concentrate during surgery.

Exclusion Criteria:

Use Extracorporeal Membrane Oxygenation after surgery, inability to obtain written informed consent
Real-world Treatment Patterns and Clinical Outcomes in EGFR-mutant Unresectable Locally Advanced NSCLC

The investigators will obtain a cohort of patients from multiple large cancer centers in China and try to unravel the efficacy of "radiotherapy combined with EGFR-TKI", which may provide some evidences for the treatment of stage III-inoperable NSCLC.

The frequency of EGFR mutations in patients with stage III inoperable adenocarcinoma or non-squamous cell carcinoma is 17-31%, which is relatively low. Compared to patients with EGFR wild type, the efficacy of radiotherapy or chemo-radiotherapy may be different in EGFR mutant patients. Some small sample studies showed, compared with patients with EGFR wild type, patients with EGFR mutations have a lower risk of local recurrence and a higher risk of distant metastasis under the standard treatment for stage III lung cancer, which demonstrate the strength of systemic therapy may help. Radiotherapy combined with EGFR-Tyrosine kinase inhibitors(TKI) is a feasible treatment strategy. In view of the low mutation frequency and few prospective research results, the investigators try to explore the survival differences of three treatment strategies used in clinical practice based on the real world data. The investigators will obtain a cohort of patients from multiple large cancer centers in China and try to unravel the efficacy of "radiotherapy combined with EGFR-TKI", which may provide some evidences for the further study.

Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed NSCLC with adenocarcinoma
* stage III (AJCC 7th edition)
* inoperable or refuse surgery
* EGFR-TKI mutation, specimen from tissue or blood

Exclusion Criteria:

* the pathology was not adenocarcinoma
* stage I,II and IV
* anaplastic lymphoma kinase (ALK) rearrangement
* no follow-up data achievable
An Electronic Health Record-based Approach to Increase PrEP Knowledge and Uptake: the EMC2 PrEP Strategy

This study is being conducted to investigate a strategy that may improve knowledge and uptake of pre-exposure prophylaxis for HIV prevention (PrEP) among cisgender women in primary care.

Members of the study team previously developed and evaluated the Electronic health record Medication Complete Communication (EMC2) strategy to 'hardwire' provider/patient communication \& surveillance of select prescription (Rx) medications. EMC2 PrEP will adapt from the previous strategy to

* educate cisgender women in primary care who have increased vulnerability to HIV about PrEP using an interactive, health literacy-appropriate educational tool securely delivered via the patient portal
* facilitate, for those who express interest, the rapid and discrete scheduling of a dedicated PrEP clinic visit with a primary care clinician trained in PrEP delivery

The current study aims are to:

Aim 1: Refine and implement an electronic health record (EHR)-based strategy as a potential quality improvement activity that supports informed decision-making and PrEP uptake among women with increased HIV vulnerability in primary care (the EMC2 PrEP strategy).

Aim 2: Pilot-test the EMC2 PrEP strategy in primary care to determine its feasibility, acceptability, and preliminary efficacy among women with increased vulnerability to HIV.

Aim 3: Develop a standard operating protocol (SOP) for disseminating the EMC2 PrEP strategy to a national network of federally qualified health centers.

Eligibility Criteria:
Inclusion Criteria:

* female
* HIV negative
* have received 2 or more tests in the past 12 months for chlamydia, gonorrhea and/or syphilis
* and/or have received a positive diagnosis for at least one of those sexually transmitted infections in the past 6 months
* currently engaged in primary care
* not currently using PrEP

Exclusion Criteria:

* severe, uncorrectable visual, hearing or cognitive impairments that would preclude study consent or participation
Role Of Self-monitoring of Blood Glucose and Intensive Education in Patients With Type 2 Diabetes Not Receiving Insulin

The aim of this pilot study is to evaluate the validity and feasibility of an educational approach involving nurses, combined with SMBG, aimed at lifestyle modification and timely changes in therapy, when needed.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Type 2 diabetes (known diabetes or new diagnosis) seen for the first time in the diabetes outpatient clinic;
* Patients on treatment with OHA monotherapy (i.e. metformin alone or sulphonylureas alone or TZDs alone);
* No need for insulin treatment;
* Male and female patients, aged between 45-75 years;
* Hba1c values between 7% and 9% included (considering a value of 6.0% as the upper limit of normal value)
* No experience of self monitoring of blood glucose in the previous 12 months (SMBG performed with a frequency of \< 1 times/week)
* Ability and willingness to comply with all study requirements
* Signature of consent form

Exclusion Criteria:

* Patients incapable to perform SMBG
* Patients needing insulin or multiple OHA association therapy
* Patients needing a regular use of SMBG (e.g. frequent hypoglycemic episodes)
* Diabetes care not exclusively managed by diabetic clinics
* Patients with serious underlying medical or psychiatric condition
COPD Co-infection With Tuberculosis on Th17 Cell Differentiation

This project will observe and follow up the changes of pulmonary function and CT in patients with smoking combined with pulmonary tuberculosis, and measure the ratio of Th1 cells, Th17 cells, macrophages and neutrophils and the secretion of factors such as TNF-α, IFN-γ and IL-17 in pulmonary blood and alveolar lavage fluid.

Chronic obstructive pulmonary disease (COPD) and tuberculosis are major global health problems, and acquired and acquired immunity play an important role in COPD and tuberculosis, and there is an interaction between COPD and tuberculosis, but the exact mechanism is not clear. Pre-existing TB infection is an independent risk factor for COPD and can aggravate pulmonary function and increase hospitalization and mortality in COPD patients. In COPD patients, Th1 and Th17 cells are involved in the development of COPD and emphysema through activation of macrophages and recruitment of neutrophils, while matrix metalloproteinases (MMPs) of macrophage and neutrophil origin are involved in the formation of tuberculosis cavities, and cytokines such as TNF-α, IFN-γ, IL-17 are involved in the mechanism of their destruction, IL-17 restricts the expression of HIF-1α to inhibit the development of TB granulomas, and CT analysis revealed that combined TB exacerbates emphysema in COPD patients. The above evidence suggests that tuberculosis plays an important role in the formation of emphysema in COPD. In this project, we will observe and follow up the changes of pulmonary function and CT in patients with smoking combined with pulmonary tuberculosis, and examine the ratio of Th1 cells, Th17 cells, macrophages and neutrophils and the secretion of TNF-α, IFN-γ, and IL-17 in pulmonary blood and alveolar lavage fluid.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of COPD
* age ≧ 40

Exclusion Criteria:

* Presence of other chronic respiratory diseases other than COPD, such as asthma, bronchiectasis, interstitial lung disease, etc.
* History of chest and lung surgery.
* History of malignancy.
* Autoimmune disease.
* Long-term oral glucocorticoids, immunosuppressants and inhaled glucocorticoids.
* Mental abnormalities, cognitive impairment, inability to cooperate with pulmonary function and other tests.
* Acute stage of infection, such as lung infection, urinary tract infection and gastrointestinal tract infection, etc.
A Dose-Ranging Study of MK-5442 in Postmenopausal Women With Osteoporosis (MK-5442-001)

The purpose of this study was to identify an appropriate dose of

MK-5442 that produced an osteoanabolic effect without causing hypercalcemia in postmenopausal women with osteoporosis.

Amendment 4 of the protocol changed the duration of the study from 2 years to 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal for at least 5 years
* No history of fragility fracture, unless participant is not willing to take marketed osteoporosis therapy or is not a candidate for marketed osteoporosis therapy
* Agrees not to use medications for osteoporosis except medications associated with the study
* Areal bone mineral density (BMD) T-score \<-2.5 at one or more of the following 4 BMD sites: total hip, femoral neck, trochanter, or lumbar spine and is ≥ -3.5 at all 4 BMD sites. Participants unwilling to take or ineligible for marketed osteoporosis therapy may have one or more areal BMD T-scores of \< -3.5

Exclusion Criteria:

* Unable to undergo dual-energy X-ray absorptiometry (DXA) scan due to obesity (ie, weight \>250 lbs)
* Use of oral bisphosphonates in the 6 months prior to study screening, for more than 3 months in the past 2 years, or lifetime use of more than 6 months
* Use of intravenous bisphosphonates, strontium, or growth hormone at any time
* Use of phenytoin or heparin within 2 weeks prior to Visit 1; use of raloxifene within 6 months prior to Visit 1
* Use of pioglitazone or rosiglitazone at study screening
* Use of estrogen ± progestin, in any form other than vaginal or topical application, for 6 months prior to Study Visit 1
* Prior total thyroidectomy
* Human immunodeficiency virus (HIV)- positive or acquired immune deficiency syndrome (AIDS)-related illness
* History of malignant cancer within 5 years of study screening, except for certain skin or cervical cancers
* History of Paget's disease and/or kidney stones
* An active user of any illicit drug
* History of or active alcohol abuse
* Participated in an investigational drug study within the past 30 days
Post-First Progression Use of Bevacizumab in Metastatic Colorectal Cancer (mCRC)

Bevacizumab beyond progression has been proven to be safe in the community setting (BRiTE) and in the post-marketing study (BEAT), and confirmed its efficacy and safety in the first line with all regimens of chemotherapy. A total of 1,953 patients were treated in BRiTE. At median follow-up of 17.5 mo, there were 1,369 1st PD and 839 deaths. Among patients with 1st PD, 65.2% received any 2nd-line chemotherapy, 34.8% received cetuximab, and 53.8% received BBP. In a multivariate analysis, Bevacizumab beyond first progression and exposure to any 2nd-line chemotherapy were independently associated with increased overall survival (both p \< 0.0001). Bevacizumab beyond progression appears to be associated with longer overall in BRiTE.

The investigators planned a prospective study to prove this phenomenon of bevacizumab beyond progression.

Patients should have been treated with bevacizumab plus chemotherapy as a 1st line treatment, and after 1st progression, these patients will be accrued in this study of bevacizumab plus chemotherapy as a 2nd line treatment, and the combined chemotherapy will be chosen by physician's decision in consider with previous chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Histologically documented colorectal adenocarcinoma
* Progression during first-line bevacizumab containing chemotherapy within 3 months
* No serious toxicity to bevacizumab of 1st line treatment
* Unresectable metastases
* Uni-dimensional measurable lesion(s) by RECIST
* Age over 18 years old
* ECOG 0-2
* Adequate organ functions by clinical laboratory exams

Exclusion Criteria:

* Other tumor type than adenocarcinoma
* CNS metastases
* GI bleeding
* Hypersensitivity to any of chemotherapeutic agents
* Prior use of cetuximab or other targeted agents other than bevacizumab
* Major surgery within 6 weeks
* Other serious illness
The Analysis of Immuno-Nutrition Index in Advanced Gastric Cancer Receiving Preoperative Treatments

Based on multiple studies, the immune (systemic inflammation) and nutrition index were correlated with short- and long-term prognosis for gastric cancer. With the increasing application of preoperative treatments (chemotherapy and chemoradiotherapy), the issues concerning how are the immuno-nutrition index be altered under the effects of perioperative treatments and what are the clinical values of these index should be clarified.

The immune (systemic inflammation) index includes:

NLR (Neutrophil-to-Lymphocyte Ratio); PLR (Platelet-to-Lymphocyte Ratio); SII (Systemic Immune-Inflammation Index); GPS (Glasgow Prognostic Score); mGPS (modified Glasgow Prognostic Score); PI (Prognostic Index);

The nutrition index includes:

NRS2002; PNI (Prognostic Nutrition Index);

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed adenocarcinoma
* Received neoadjuvant (preoperative) chemotherapy or chemoradiotherapy
* Diagnosed clinical advanced gastric cancer or esophagogastric cancer

Exclusion Criteria:

* Lack of immuno-nutrition data
Characterization Phenotypic and Genetic Study of the Intestinal Epithelial Dysplasia or Tufting Enteropathy (TE)

This PHRC is centred on the intestinal epithelial dysplasia ( DEI) or " tufting enteropathy " or TE the clinical and histo-pathological descriptions of which are specified well to the digestive plan(shot).

The objectives of this PHRC are:

* the phenotypic analysis of the intestinal epithelial dysplasia by clinical and histo-pathological investigations.
* the identification of proteins involved at the intestinal level in the differentiation, the proliferation and the membership of the epithelial cells
* from the phenotypic study, a genetic analysis of type maps by homozygote on the whole genome partner in an approach guided by possible candidate genes
* the study of the genes, chosen according to their location, to their profile of expression, and to their function in touch with the pathogenic hypotheses

Eligibility Criteria:
Inclusion criteria :

Patient sent in the service of Gastroenterology Pediatric Hepatology of the Hospital Necker Enfants Malades for an intestinal transplantation, from 0 to 15 years old presenting:

* A known epithelial dysplasia (Diagnosis established on the clinical and histo-morphological criteria from one or several intestinal biopsies, with or without diagnosis known or suspected in the family). The objectives are the phenotypic characterization of the case and the revealing of markers characteristic immuno-histochemistry which can be of use to the diagnosis and direct to candidate genes
* Or a suspicion of dysplasia epithelial (compatible clinical History(Story) with or without extra-digestive demonstrations(appearances) of type keratinate punctuated superficial (KPS), abnormalities cutanea or atresia CHOANS with atypical digestive histology and without diagnosis known in the family). The objectives are the diagnosis on the basis of the immuno-histochemistry expression and the existence of an infringement(achievement) conjunctival and the phenotypic characterization of the case
* The lit(enlightened) and written consent of both holders of the parental authority must be beforehand obtained as well as that of the patient if it is in age to understand(include).

Exclusion criteria :

* Not membership in a national insurance scheme (beneficiary or legal successor)
* Family not understanding(including) French
* Refusal of one of both relatives(parents)
A Study of the Rules for Insulin Dosing in Patients Using Multiple Daily Injections

This study will be conducted in subjects with Type 1 diabetes mellitus on multiple daily insulin injections to determine the correct insulin dosing formulas. Subjects will be evaluated using continuous glucose monitoring.

Subjects with stable type 1 diabetes mellitus on multiple daily insulin injections including basal and bolus will be selected in order to determine the correct insulin dosing formulas. Subjects will be placed on continuous glucose sensor (CGMS) and an isocaloric diet. Subjects will have the CGMS downloaded daily and the insulin doses adjusted if necessary. Subject will do four SMBGs daily to calibrate CGMS and on last day a 7-point SMBG. subjects will be on lispro and glargine insulin. Basal insulin will be once a day.

Eligibility Criteria:
Inclusion Criteria:

* Age: \>17 years
* Type 1 diabetes
* Diabetes duration \> 3 months
* On treatment with multiple daily injections either one or more basal insulin injections each day for 6 weeks
* HbA1c \<9.0%
* Stable HbA1c in the proceeding 3 months (i.e., change \<1%)
* Demonstrated adherence to visits and instructions
* Attend a class in meal carbohydrate content estimation or have demonstrated knowledge of carbohydrate counting

Exclusion Criteria:

* Major stress event during or for 6 weeks before the evaluation
* Taking a medication that can alter insulin sensitivity
* Within one week of menses
* Unstable eating or activity pattern
* Pregnancy
* Weight gain of \> 1.5 kg during the preceding 3 months
* Serum creatinine of \>1.5 mg/dl
* Active liver disease
* Evidence of autonomic neuropathy, especially gastroparesis
* Any antidiabetic medication other than insulin
* Treatment with continuous subcutaneous insulin infusion