cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate a New Jaundice Stick Test

This is an observational prospective study. The main purpose is to evaluate the stability of the Bilistick system in a humid and hot climate compared to the quantitative test for serum bilirubin (SBR) measurement currently used, the BR-501 total bilirubin meter, kept in a controlled environment.

The secondary aim is to assess the operational feasibility of the Bilistick system in a tropical limited-resource setting, when used by locally trained nurses.

Study procedure:

1. SBR will be measured in parallel with two tests during three distinct seasons. (Cold, hot, rainy). The Blood is from an extra capillary sample taken from a single heel prick done for routine SBR) BR-501 total bilirubin meter, the quantitative test for SBR currently used, will be kept in a controlled environment while the new bilirubin test (Bilistick system) will be exposed to tropical conditions.
2. Trained nurses will use the Bilistick system observed by a qualified laboratory technician; Usability of the Bilistick system by the trained nurses will be evaluated via a 5-point Likert scale questionnaire and focus groups discussions.

Eligibility Criteria:
Inclusion Criteria:

* Written or thumb print for informed consent from the parent
* Infant born ≥ 35 weeks of gestational age
* Infant who needs a routine SBR measurement
* Infant in stable clinical condition prior to SBR measurement confirmed by the trained nurses

Exclusion Criteria:

The participant will not be enrolled in the study if ANY of the following applies:

* Infant who already had 1 SBR measurement done with the Bilistick system
* Last haematocrit measurement \> 65% or no previous haematocrit measurement
Use of Melatonin for Preventing POCD in Transurethral Prostate Resection Under Spinal Anesthesia

This study aims to evaluate the possible effect of melatonin on prevention of cognitive dysfunction in the postoperative period of elderly patients undergoing transurethral resection of the prostate (TURP) under spinal anesthesia

TURP is the most common surgical procedure performed on male patients over 60 years of age to treat benign prostatic hyperplasia.

One of the concerns, since it compromises the quality of life, is postoperative cognitive dysfunction. It can be due to TURP Syndrome or to other causes, like changing the routine and circadian rhythm for patients with more susceptibility.

The investigators postulate that melatonin premedication and use during the perioperative period could avoid cognitive impairment in patients undergoing TURP surgery that didn't develop major complications, like TURP Syndrome.

Since anesthestic technic could also influence the outcome of POCD, only patients undergoing spinal anesthesia were included in the study,

Eligibility Criteria:
Inclusion Criteria:

patients over 60 years who underwent elective surgery for transurethral prostate ressection under spinal anesthesia.

MME \> 18 (for those who had less than 4 years of formal education ) or MME \> 23 (for those with 4 or more years of formal education)

Exclusion Criteria:

MME \< 18 (for those who had less than 4 years of formal eduaction) or 23 (for those with 4 years or more of formal eduacation); History of cancer, brain disease, seizure, Parkinson, dementia, hallucination or any disorder that affects cognition before the surgery.

Lack of proficiency in portuguese mild or severe hearing loss or blindness.
ONS in Gastric Cancer After Total Gastrectomy

Gastric cancer patients after total gastrectomy will be randomized to oral nutritional supplement group or control group at discharge. Patients will receive 6 months of oral nutritional supplement or normal diet after discharge. The primary and secondary outcomes will be collected.

Gastric cancer patients after total gastrectomy at discharge, if she/he has nutrition risk (NRS2002≥3), then she/he will be randomized to oral nutritional supplement (ONS) group or control (C) group after discharge. In the ONS group, in addition to diet, and patients will also consume enteral nutritional powder (500ml/d，500kcal/d) lasted for 6 months. In the C group, patients will receive normal diet. Both groups will receive nutrition counseling.

The primary and secondary outcomes will be collected.

Eligibility Criteria:
Inclusion Criteria:

1. Informed consent of patients or their legal representatives to participate in this study
2. consecutive adult (18-80 years) patients underwent radical gastrectomy (total gastrectomy)
3. nutrition Risk Screening (NRS) 2002≥3 at discharge
4. eastern Cooperative Oncology Group (ECOG) score of 0-2 at discharge
5. normal liver and kidney function

Exclusion Criteria:

1. unable to oral or consume ONS
2. allergy to any ingredient in the oral nutrition powder
3. pregnancy
4. palliative surgery or gastric stump cancer
5. congenital acquired immune deficiency disease
6. severe liver and kidney diseases including active hepatitis, cirrhosis, and uremia diabetes has developed complications or uncontrolled by medications
7. motor system diseases cannot complete grip strength measurement and 5-time chair stand test
8. have cognitive impairment, unable to complete the relevant questionnaires
9. expected to require tube feeding after discharge from the hospital
Rotator Cuff Tears in Hemiplegic Shoulder

The purpose of the study is to evaluate the prevalence of rotator cuff tears in the shoulders of hemiplegic patients of different severity.

Rotator cuff tears are often suspected to contribute hemiplegic shoulder pain. However, it is controversial whether their incidence increases in hemiplegia. Based on the postulate that muscle weakness in hemiplegia predisposes rotator cuff injury due to biomechanical failure, this study aims to investigate whether the rotator cuff tears are associated with the muscle strength of the shoulder by observing hemiplegic shoulders of varying degree of paresis.

Eligibility Criteria:
Inclusion Criteria:

* hemiplegia; unilateral weakness of sudden onset
* secondary to strokes or other brain lesions
* compatible with brain lesions confirmed by imaging studies

Exclusion Criteria:

* bilateral weakness
* any history of intensive trauma of the shoulder, reported
* preexisting musculoskeletal disorder of the shoulder
Main Branch Versus Side Branch Ostial Lesion

The investigators studied the relations between coronary angiography (CAG), intravascular ultrasound (IVUS) and fractional flow reserve (FFR) in coronary ostial lesions.

Angiographic evaluation for ostial lesions is reported to be inaccurate in the assessment of the functional and clinical significance of a lesion. The investigators studied the relations between coronary angiography (CAG), intravascular ultrasound (IVUS) and fractional flow reserve (FFR) in coronary ostial lesions.

Eligibility Criteria:
Inclusion Criteria:

* Age 21-85
* Presence of at least one obstructive coronary artery stenosis at coronary ostium as defined by:
* Previous catheterization with any coronary ostium lesion 50% or greater
* Ability and Willingness to provide informed consent
* Ability and Willingness to perform required follow up procedures

Exclusion Criteria:

* History of coronary artery bypass graft surgery
* left main coronary ostial lesion
* significant stenosis at proximal or distal part of coronary ostium lesion
* ostial lesion related to infarcton
* Creatinine\>1.6 mg/dL or GFR\<30 pre-procedure per institutional standards
* Ejection fraction lower than 40%
* Known Pregnancy
* Arrhythmia
* Contrast agent allergy that cannot be adequately premedicated
* Patient not a candidate for IVUS and FFR
* Inability or unwillingness to provide informed consent
* Inability or unwillingness to perform required follow up procedures
TTVR STRONG Under Coverage With Evidence Development (CED) Study

This Coverage with Evidence Development (CED) study measures the long-term health outcomes of patients with severe, symptomatic Tricuspid Regurgitation who received a Transcatheter Tricuspid Valve Replacement procedure using the EVOQUE system.

This is a retrospective, non-randomized cohort study measuring 2-year effectiveness of the EVOQUE Transcatheter Tricuspid Valve Replacement (TTVR) system in the real-world.

This study will retrospectively evaluate EVOQUE treated patients in the STS/ACC TVT Registry who have at least severe Tricuspid Regurgitation and can be deterministically linked with Medicare data.

This group will be compared to Medicare eligible and EVOQUE eligible patients evaluated in a standard of care setting from a commercial claims database linked with electronic health records.

We will evaluate the primary outcome measure in various subgroups.

There will be continued access enrollment after the primary completion date.

Eligibility Criteria:
Inclusion Criteria:

Medicare eligible patients who have received an EVOQUE device or are EVOQUE eligible and have at least severe Tricuspid Regurgitation

Exclusion Criteria:

Commercially insured patients who have received an EVOQUE device or are EVOQUE eligible or Medicare eligible patients with less than severe Tricuspid Regurgitation
Organization Program of DiabEtes INsulIN ManaGement

Diabetes is a common, costly condition associated with significant morbidity and mortality. Diabetes self-management education, the process of teaching individuals to manage their diabetes, has been considered an important part. The intensive education has the capacity to deliver effective interventions to a large number of people. The investigators may be able to redirect our efforts to diabetes care and education strategies that will have a positive impact on the optimization of glycemic control and the prevention of long-term complications of diabetes, reducing the subsequent human and health care costs.

This is a prospective, randomized, open-label, controlled clinical study. 1500 subjects with Type 2 DM will be enrolled and be randomized into Structured Education Group and Conventional Education Group in 1:1 ratio. Subjects in both of the groups will be treated with Scilin®M30 twice daily (30 minutes before breakfast and dinner). All the previous oral antidiabetic drugs (OAD(s)) will be discontinued except metformin and alpha-Glucosidase Inhibitors. The physician will determine the starting dose (0.3 IU/kg～0.4IU/kg), as well as later changes to dose according to insulin titration algorithm. The treatment duration will last 16 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Written Informed Consent obtained before any trial-related activities Type 2 DM subjects;
* Age \> 18 years old,male or female;
* Continuous treated with two or more oral antidiabetic drugs (OADs) for the last 3 months,and the current HbA1c\>7.5%;
* Cooperative with structured management;

Exclusion Criteria:

* Subjects with type 1 diabetes;
* Gestational diabetes mellitus and other specific types DM;
* Those who are unwilling to sign in ICF;
* Subjects with repeated hypoglycemia;
* Subjects with BMI\>30kg/m2;
* Impaired liver function,defined as alanine aminotransferase (ALAT)\>= 2.5 or alkaline phosphatase (ALP)\>= 2 times upper referenced limit times upper normal limit;
* Females of childbearing age who are pregnant, breast-feeding or have the intention of becoming pregnant or not using adequate contraceptive methods throughout the trial (adequate contraceptive measures as required by local law or practice);
* Mental incapacity, unwillingness, or language barrier precluding adequate understanding or cooperation;
* Any other clinically significant condition or major systemic diseases, including serious coronary heart disease, cardiovascular disease, myocardial infarction within the past 12 months; severe neurology or psychology or psychiatric diseases; serious infection; actively disseminated intravascular coagulation;
* Malignant neoplastic diseases (except carcinoma in situ);
* Current addiction to alcohol or other addictive substances;
Evaluation of Optical Pumping Magnetometer Sensors for MagnetoEncephaloGraphy Imaging

This research is a feasibility study on a new generation of brain magnetic activity sensor which should allow the development of this modality, until now limited by its cost to a few large university centers.

The measurement of magnetic activity allows the detection and localization of abnormal activities such as paroxysmal events occurring between seizures in patients with epilepsy as well as research into brain function. It is the only one, along with EEG and related techniques, to provide data related to the speed of the brain. MEG, by virtue of the properties of magnetic fields, has a greater potential than EEG for the detection and localization of the neuronal sources which cause it.

The MEG sensors used until now use Superconducting Quantum Interference Devices (SQUID) components that are extremely sensitive but require complex instrumentation and only operate under superconducting conditions, resulting in prohibitive maintenance and cost.

The alternative could come from a new magnetic activity sensor: the optical pumping magnetometers of the alkaline type.

This preliminary study proposes to compare SQUID sensors with MPO He4 sensors for their ability to detect abnormal activities recorded in epileptic patients. Measurements that cannot be recorded simultaneously Two types of measurement will be compared with the reference that constitutes in-depth recording (Stereotactic-EEG or SEEG) used to precisely define the region of the brain to be resected in order to cure epileptic patients of their seizures.

The expected results are a capacity of this type of sensors to detect epileptic activities equivalent to that of SQUIDs.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient (≥ 18 years old)
* Patient with drug-resistant focal epilepsy, undergoing SEEG exploration
* Healthy subject, devoid of central neurological pathology, major ((≥ 18 years)
* Patient or healthy subject capable of giving informed consent for the study

Exclusion Criteria:

* MEG "incompatible" healthy patients or volunteers.
* Wearers of prosthesis or pacemaker likely to generate artefacts interfering with the measurement. There is no danger to the subject, but the measurement itself may be impossible.
* Patients or healthy volunteers who cannot stand standing still for a few minutes.
* Pregnant or breastfeeding women
* Adults under guardianship or under legal protection
* People deprived of their liberty
* People who have not signed the informed consent
Blood Viscosity in Polycythemia Patients

Polycythemia (PG) corresponds to an increase in erythrocyte parameters on a blood test. A distinction is usually made between primary and secondary PG. The most common primary PG is Vaquez's disease, a hematological cancer. In Vaquez disease, an increase in hematocrit has been reported to be associated with a logarithmic increase in blood viscosity.

The main complications of primary PGs (especially in Vaquez disease) are thromboembolic complications. In contrast, thromboembolic complications are rarer in secondary PG. In Vaquez disease, a hematocrit ≤ 45% has been defined as the therapeutic goal for significantly reducing thromboembolic risk. However, this has not been established for secondary PGs. All in all, the definition of the 45% threshold is based solely on clinical studies with no obvious biological argument. What's more, simply lowering blood mass through cytoreduction alone does not appear to be sufficient to significantly reduce thromboembolic risk.

To investigator knowledge, there are no studies prospectively evaluating blood viscosity, its determinants and coagulation in different types of polycythemia. Nor are there any data on the direct effect on blood viscosity of the various treatments usually offered.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Followed for a diagnosis or suspicion of polycythemia (hematocrit greater than or equal to 49% in men and 48% in women), whatever the suspected etiology.
* Patient affiliated to a social security scheme or similar

Exclusion Criteria:

* Patient having undergone therapeutic bloodletting within 3 months prior to inclusion, or having initiated cytoreductive therapy prior to inclusion.
* Any disease or condition other than polycythemia, chronic or not, likely to induce a change in blood viscosity (at the investigator's discretion)
* Patient participating in another interventional research protocol that may interfere with the present protocol (at the investigator's discretion).
* Patient under guardianship, curatorship or safeguard of justice
* Person under psychiatric care
* Patient under legal protection.
S-ICD® System Post Approval Study

The purpose of the S-ICD Post Approval Study is to document long term safety and effectiveness outcomes associated with the implantation of the SQ-RX pulse generator and Q-TRAK electrode in a commercial clinical setting.

The S-ICD Post Approval Study is a non-randomized registry that will retrospectively enroll subjects who participated in the S-ICD Clinical Investigation (IDE G090013) and prospectively enroll new candidates for the S-ICD System. The target enrollment sample size is 1,616 subjects at up to 150 investigational sites to achieve 1,025 subjects in the analysis cohort at 60 months.

* The primary safety endpoint of the study is the Type I (caused by the S-ICD System) Complication Free Rate at 60 months compared to a performance goal of 85%.
* The primary effectiveness endpoint is the Overall Shock Effectiveness in Converting Spontaneous Discrete Episodes of ventricular tachycardia /ventricular fibrillation (VT/VF) through 60 months compared to a performance goal of 94%.
* The secondary safety endpoint of the study is the Electrode-Related Complication Free Rate at 60 months compared to a performance goal of 92.5%.
* The secondary effectiveness endpoint is First Shock Effectiveness in Converting Induced (Acute) and Spontaneous Discrete Episodes of VT/VF through 60 months compared to a performance goal of 84.0%.

Additional objectives include characterization of long term safety and effectiveness in subjects of varied body habitus and in traditionally underrepresented populations.

Subjects must meet the following criteria to be eligible for inclusion in the study:

1. Eligible for implantation with an S-ICD System, OR previously implanted with an S-ICD System in the S-ICD System Clinical Investigation (IDE G090013)
2. Willing and able to provide written informed consent or have informed consent provided by a legal representative

Subjects who meet the following criteria must be excluded from the study:

1. Remaining life expectancy of less than 360 days

Enrolled subjects will be followed at the implant procedure, pre-discharge and annual (±60 days) follow-up visits. Subjects are followed according to the standard of care at their participating investigational center.

The primary and secondary safety and effectiveness endpoints will include a compilation of S-ICD IDE study and S-ICD PAS study subject data

Eligibility Criteria:
Inclusion Criteria:

* Eligible for implantation with an S-ICD System, OR previously implanted with an S-ICD System in the S-ICD System Clinical Investigation (IDE G090013)

AND

* Willing and able to provide written informed consent or have informed consent provided by a legal representative

Exclusion Criteria:

* Remaining life expectancy of less than 360 days
Assessing Inherited Markers of Metabolic Syndrome in the Young

The AIMM Young study is a collaboration between Children's National Medical Center (CNMC) and colleges/universities nationwide--currently including Howard University (HU), East Carolina University (ECU), and University of Massachusetts, Amherst (U Mass). This study obtains a variety of baseline measures (such as serum biomarkers related to metabolic syndrome, anthropometrics, muscle strength, and fitness testing) along with genetic information from healthy college-age (18-35 years) young adults in efforts to identify phenotype-genotype associations that may predispose individuals to developing metabolic syndrome, type 2 diabetes, and/or related diseases such as obesity.

We hypothesized that certain genetic variations will be protective against metabolic syndrome, while others will show a strong correlation with specific components of metabolic syndrome disease. We expect that the study of "pre-symptomatic," young individuals will facilitate the identification of genetic risk loci for metabolic syndrome and type 2 diabetes. Younger populations typically have less confounding variables, and this facilitates normalizing of metabolic syndrome features and environment/lifestyle. Additionally, young subjects can provide more robust longitudinal data, and be recruited into subsequent interventions to reverse the trend towards metabolic syndrome, rather than the more difficult task of reversing type 2 diabetes in older populations. The data collected will be stratified according to gender, age, ethnicity, genotype, and other phenotypic measures to determine how these factors influence disease risk.


Eligibility Criteria:
Inclusion Criteria:

* between the ages of 18 and 35 years
* post-puberty
* willing and able to provide informed consent
* stable medical and psychosocial status providing a high likelihood of follow-up and compliance with study protocol
* all ethnic backgrounds will be included in this study.

Exclusion Criteria:

* evidence of clinically relevant systemic disease associated with disorders of glucose metabolism
* chronic use of glucocorticoid or appetite suppressants
* concomitant use of drugs known to alter glucose metabolism (i.e., metformin, thiazolidinediones, sulfonylurea receptor agonists and inhibitors of alpha-glucoside hydrolase) or other medications known to alter blood levels being tested in this study
* inability to provide the requested fasting blood sample
* pregnancy
* menopause
* alcohol dependency (as determined by CAGE screening questionnaire); (8) inability to provide informed consent
* previous diagnosis or treatment for any hematologic-oncologic disorder
* history or current treatment for an eating disorder
* current treatment for weight loss
* history of bariatric surgery
* history of neurosurgical procedure
* participation in another clinical trial involving an investigational drug
* history of psychiatric disorder, which in the opinion of the investigator would affect the conduct of the proposed trial
* age younger than 18 or older than 35 at the time of recruitment
* weight that exceeds the capacity of equipment used for weight measurements.
Multicenter Study of the Avenue L Interbody Spinal Fusion System Using VerteBRIDGE Plating and Posterior Fixation

The purpose of this prospective clinical study is to examine the short-term safety and efficacy of the Avenue®- L interbody Spinal Fusion System with VerteBRIDGE® plating to treat one and two level degenerative disc disease between L2 and S1 with a focus on fusion rate.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be candidates for on-label use of the Avenue L device (have degenerative disc disease, use only at one or two contiguous levels, posterior fixation must be used, autograft must be used in the interbody cage)
* Subject must be skeletally mature at the time of surgery, i.e. the subject must be at least 21 years of age at the time of surgery
* Subject should have had a minimum of 6 months of non-operative treatment prior to surgery
* The placement of the Avenue L device must be a primary surgery
* Subject must be willing to sign the consent form and be able to return for all follow up visits.

Exclusion Criteria:

* Subject must not have had prior surgery at the operative level(s)
* Subject is known to have substance or alcohol addictions
* Subject has lateral curvature of the spine (scoliosis, all types)
* Subject is a prisoner
* Subject is pregnant
* Subject has an active infection or sepsis at the time of surgery
* Subject has any neuromuscular disorder that would preclude accurate neurologic evaluations