cyrilzakka/clinical-trials huggingface dataset:
Adolescent Type 1 Diabetes Cardio-Renal Intervention Trial

The purpose of this study is to determine whether use of blood pressure lowering drugs, Angiotensin converting enzyme inhibitors (ACEIs) and blood fat (lipid) lowering drugs (statins) may have a place in the treatment of adolescents with diabetes and can help reduce serious long-term health problems in this population.

Subjects will be recruited from a pre-screened population of 3,000 young people with T1D aged 10 to 16 years based on assessment of risk for future CVD and DN.

They will be randomised to a 2 x 2 factorial design contrasting the effects of ACEI, statins, or combination therapy to placebo over a maximum four year treatment period. Minimisation of variation in albumin excretion rate, gender, age, diabetes duration, HbA1c, total cholesterol and centre site will be undertaken at randomisation.

Analysis of the primary endpoint, change in albumin excretion will be undertaken on an intention to treat basis. Secondary analyses will be undertaken on the basis of 'as treated' allowing for variance in compliance and allowing for subjects who show substantial change in HbA1c levels. Additional analyses will be undertaken to assess changes in the secondary objectives and to assess the overall effect of the intervention on quality of life and health economics.

Eligibility Criteria:
Inclusion Criteria:

1. Age 10 to 16 years.
2. T1D diagnosed for more than 1 year or C-peptide negative.
3. Centralised assessment of ACR based on six early morning urines deemed to be in upper tertile for risk after adjustment for age, gender, age at diagnosis and duration of disease.

Exclusion Criteria:

1. Non T1D, i.e. type 2 diabetes, insulin dependent diabetes related to monogenic disease, secondary diabetes.
2. ACR based on six early morning urines deemed to be at low risk for subsequent development of CVD or DN.
3. Pregnancy or unwillingness to comply with contraceptive advice and regular pregnancy testing throughout the trial.
4. Breast feeding
5. Severe hyperlipidaemia and family history data to support diagnosis of familial hypercholesterolaemia.
6. Established hypertension unrelated to DN.
7. Prior exposure to the investigational products, statins and ACEI.
8. Unwillingness/inability to comply with the study protocol.
9. Other co-morbidities considered unsuitable by the investigator (excluding treated hypothyroidism and coeliac disease).
10. Proliferative retinopathy.
11. Renal disease not associated with Type 1 Diabetes.
Biomarker Targeted Stimulation for Epileptiform Events

This is a multicenter, prospective, controlled study designed to evaluate treatment with the BTS System.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is greater than or equal to 7 years of age.
2. Subject has focal onset seizures.
3. Subject has failed treatment with a minimum of two AED's used in typical therapeutic dosages.
4. Subject has seizures that are distinct, stereotypical events that can be reliably counted by the patient or caregiver.
5. Subject can reasonably be expected to maintain a seizure diary and the BTS System alone, or with the assistance of a competent individual.
6. For one month prior to enrollment, subject's anti-epileptic medication dosages and ketogenic diet (as applicable) have been stable (other than acute, intermittent use of benzodiazepines) and subject has had at least three primary, disabling seizures per month, on average. Seizures must be separated by a minimum of eight hours not to be considered part of a cluster. A cluster, for the purpose of this criterion, shall be considered a single seizure.
7. Subject is able to complete regular office visits and telephone appointments in accordance with the study protocol requirements.
8. A female subject of childbearing age must have a negative serum pregnancy test within two weeks prior to implant of the INSR, and, if sexually active, must be using a reliable form of birth control, be surgically sterile, or be at least two years post-menopausal.
9. Subject has been informed of their eligibility for resective surgery as a potential alternative to the study, if such surgery is a reasonable option.
10. Subject has had a brain MRI epilepsy evaluation within the past two years.
11. Subject's anatomy will permit implantation of the INSR within 20 mm of the skin surface.

Exclusion Criteria:

1. Subject has a history of substance abuse within the preceding two years.
2. Subject participated in another drug or device trial that may confound study results within the preceding 30 days.
3. Subject is implanted with pacemaker, implantable cardiac defibrillator, cardiac management product, or a medical device that interferes with the BTS System or with which the BTS System interferes. Patients with a vagus nerve stimulator (VNS) implanted may be enrolled, provided their clinical status has been stable for at least one month prior to enrollment at their current stimulation parameter settings.
4. Subject has anatomy that may interfere with electrode placement.
5. Subject is on anticoagulants and is unable to discontinue them perisurgically, as required by the neurosurgeon or Investigator.
6. Subject has significant platelet dysfunction from medical conditions or medications (including, particularly, aspirin or sodium valproate). If platelet dysfunction is suspected, subject can be enrolled only if a hematologist, the Investigator, and the neurosurgeon judge it to be advisable.
7. Subject has been diagnosed with psychogenic or non-epileptic seizures that cannot be distinguished from their epileptogenic events.
8. Subject is ineligible for cranial surgery.
Clinical Trial to Evaluate MDW for Early Detection of Sepsis

This study is intended to clinically verify Monocyte Distribution Width (MDW) parameter of DxH 900 Hematology Analyzer for use in early detection and risk assessment of sepsis, severe sepsis, and septic shock in critically ill patients in Emergency Department (ED). This study is also aimed to provide study supporting data for the product to be marketed in China.

To verify the clinical performance of MDW parameter in detection of sepsis through a multicenter, prospective study of adults undergoing complete blood count with differential ("CBC with differential") in the ED.

To clarify the cutoff 20.0 established in the pivotal trial. The cutoff was established for the objective of achieving the highest sensitivity at the optimal specificity level. Patients whose MDW value is higher than the cutoff will be identified as sepsis patients and those whose MDW value is equal to or lower than the cutoff are non-sepsis patients.

Eligibility Criteria:
Inclusion Criteria:

* Adult subjects (18-89 years) presenting to ED.
* CBC with Differential performed upon presentation as part of standard of care.
* Subject scheduled for at least 12 hours follow-up during ED (or inpatient, if admitted to the hospital) visit
* Signed the informed consent form

Exclusion Criteria:

* Subjects previously enrolled in this study (i.e., re-enrollment to this study is not allowed).
* The subject is discharged from the hospital within 12 hours after ED visit
The Extremities Rehabilitation Training System for Sarcopenic Hospitalized Aged 80+ Years

Most previous clinical trials that addressed the rehabilitation training system for sarcopenic elderly subjects focused on community-dwelling older adults who were relatively healthy. There is a notable paucity of high-quality research investigating the effects and feasibility of the device for hospitalized or institutionalized older people, who are generally frailer and more severe in functional impairment than those living in the community. Moreover, most reported the system were of long-term duration, which typically lasted 3 to 6 months with two sessions per week. It remains unclear whether short-term the device training would be effective for treating sarcopenia. Therefore, the investigators aimed to assess the effectiveness of Motor-Assisted and Active Resistive Upper/Lower Extremities Rehabilitation Training System for treating sarcopenia in hospitalized older patients aged 80 years and over.


Eligibility Criteria:
Inclusion Criteria:

* Sarcopenia defined by the Asia Working Group of Sarcopenia (AWGS)
* Agree to participant this study and sign the informed consent
* Aged 80 years or over

Exclusion Criteria:

* Patients who could not follow the training plan due to cognitive impairment, emotional problems or any other reasons;
* Severe heart and lung diseases;
* Renal insufficiency;
* Any type of tumor;
* Bedridden patients
Genetic Association Study Between Single Nucleotide Polymorphisms (SNPs) and Cognitive Performance in Young Bipolar Type I Patients: LICAVALGENE

This is a genetic association study of cognitive impairment in young bipolar disease type I patients without medications in mania, depression, hypomania or mixed states.

Introduction:

Cognitive impairment in bipolar disease (BD) patients is common and recent data suggests that it may be an endophenotype of the disease as it differs individually, persists during periods of euthymia and co segregates in families of BD patients. Cognition is a complex trait and is therefore likely to be underpinned by many genes, each with a relatively small effect. Performance in each domain of the neuropsychological assessment can be statistically linked to the functional activity of particular protein and by extension to the genetic variants accounting for theses functional differences.

Methods:

80 patients with BD type I (SCID DSM-IV), age from 18 to 35 years old, currently on mania, depression, hypomania or mixed state after medication wash out will be submitted to complete neuropsychological evaluation and genotyped for COMT (val158met, rs165599, -287, rs737865), ApoE (epsilon 4) and BDNF (val66met)and 80 healthy controls.

Eligibility Criteria:
Inclusion Criteria:

* BD type 1
* non euthymia
* 18-35 y.o.

Exclusion Criteria:

* pregnancy
* organic disease
* use of drugs
* schizophrenia
* mental retardation
* illiterate
Cardioneuroablation vs Pulmonary Vein Isolation in Treatment of Paroxysmal Atrial Fibrillation

The goal of this study is to compare effectiveness of cardioneuroablation of right anterior ganglionated plexus and pulmonary vein isolation in patients with enhanced vagal tone expressed as deceleration capacity \>7.5ms.

Patients included into the study will be randomized to a group undergoing cardioneuroablation (CNA) of the right anterior ganglionated plexus (RAGP) or pulmonary vein isolation (PVI).

In CNA group the location of RAGP will be determined anatomically below the superior vena cava ostium near the superior-septal aspect of the right atrium. Radiofrequency (RF) applications will be delivered and will be continued until heart rate (HR) acceleration \>30% is achieved or if the RF time exceeds 120s.

In the PVI group point-by-point RF isolation of all pulmonary veins will be performed.

Clinical follow-up (FU) will consist of multiple ambulatory visits combined with standard ECG readings and a 7-day Holter recording. During FU visits, a detailed history of any palpitations, episodes of atrial fibrillation (AF), and hospitalizations for cardiac arrhythmias will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Paroxysmal atrial fibrillation documented in ECG or Holter monitoring
* Deceleration capacity \>7.5ms
* Life expectancy more than 1 year
* Age ≥18 years

Exclusion Criteria:

* Permanent AF lasting more than one year or persistent AF lasting more than 7 days
* AF secondary to electrolyte imbalance, thyroid disease, alcohol abuse, or other non-heart related causes
* Anteroposterior dimension of the left atrium in the echocardiography ≥43mm
* Clinically significant arrhythmias other than AF
* Significant valvular disease
* Valve prosthesis
* Heart failure III or IV Class in New York Heart Association Classification
* Previous ablation of atrial fibrillation or atrial flutter
* History of a patent foramen ovale/atrial septal defect closure
* History of left atrial appendage closure
* Atrial myxoma
* Presence of a cardiac pacemaker, defibrillator or cardiac resynchronization therapy device
* History of pericarditis
* Congenital heart disease
* History of bleeding or coagulation disorders
* Contraindications to oral anticoagulation
* Contraindications to computed tomography or magnetic resonance imaging
* Pregnancy or breast-feeding
* BMI\>31
* History of transplantation
* Severe lung disease
* Chronic renal failure defined as estimated glomerular filtration rate (eGFR) \<30 mL/min/m2
* Cancer
* Significant infection
* Life expectancy less than one year
* Mental disorders
* Lack of informed consent to participate in the trial
Kronos Early Estrogen Prevention Study (KEEPS)

The study will examine the effects of estrogen and progesterone on the development of atherosclerosis in menopausal women when hormone treatment is initiated within 3 years of the menopausal transition.

The KEEPS is designed to explore the hypothesis that early initiation of hormone therapy, in women who are at the inception of their menopause, will decrease the rate of accumulation of atherosclerotic plaque, indicating a likely delay in the onset of clinical cardiovascular disease. The study is designed as a multicenter, 4 year randomized clinical trial. It will evaluate the effectiveness of of 0.45 mg/day of oral conjugated equine estrogens or 50 mcg/day of transdermal estradiol via skin patch changed weekly (each in combination with cyclic oral, micronized progesterone, 200 mg daily for 12 days per month), versus placebo in preventing progression of carotid intimal medial thickness by sonogram and the accrual of coronary calcium in women aged 42-58 who are within 36 months of their final menstrual period at initiation of treatment. A number of secondary endpoints including biochemical and genetic risk factors for cardiovascular and thrombotic disease, and effects on cognition will also be studied. The study will enroll a total of 720 women in 2005-6, with an anticipated completion of the trial in 2010.

Eligibility Criteria:
Inclusion Criteria:

* menses absent for at least 6 months and no more than 36 months
* good general health
* plasma FSH level greater than or equal to 35 mIU/ml
* estradiol levels \< 40 pg/ml
* normal mammogram within 1 year of randomization

Exclusion Criteria:

* use of hormone replacement or supplement within 3 months of randomization
* endometrial thickness \>5 mm by vaginal ultrasound
* in utero exposure to diethylstilbestrol (DES)
* current smoking \> 10 cigarettes/day
* obesity-body mass index \> 35
* history of clinical cardiovascular disease
* history of cerebrovascular disease
* history of thromboembolic disease
* coronary calcium score ≥ 50 units
* dyslipidemia-LDL cholesterol \>190 mg/dl
* hypertriglyceridemia-triglycerides \>400 mg/dl
* lipid lowering medication (statin, fibrate,or \> 500 mg/day of niacin)
* nut allergy (Prometrium includes peanut oil)
* uncontrolled hypertension-systolic BP \>150 and/or diastolic BP \> 95
* hysterectomy
* history of, or prevalent, chronic diseases including any cancer (other than basal cell skin cancers), renal failure, cirrhosis, diabetes mellitus, and endocrinopathies other than adequately treated thyroid disease
* known HIV infection and/or medications for HIV infection
* results of any safety laboratory test chemistries, (TSH, CBC, U/A) more than 20% abnormal
Intensive Care Unit (ICU) Sleep Quality and Neurocognitive Performance

The purpose of this study is to understand patients' neurocognitive performance shortly after discharge from the Medical Intensive Care Unit (MICU) and the potential effect of sleep quality in the MICU on those neurocognitive outcomes. The investigators hypothesize that post-ICU neurocognitive function and patient overall ICU sleep experience will improve through a pre-existing MICU sleep improvement initiative.

Despite decades of scientific interest in evaluating sleep among critically ill patients, little is known about the effects of intensive care unit (ICU)-associated sleep disturbances on patient outcomes. Furthermore, few interventions have been rigorously evaluated to demonstrate efficacy in improving sleep in the ICU and associated patient outcomes. Post-ICU neurocognitive test performance data from this study will be linked to a pre-existing Quality Improvement (QI) project for patient sleep in the MICU. We hypothesize that patients' post-ICU neurocognitive performance (delirium status, attention, short-term memory, processing speed, and executive function) will positively correlate with scores from a previously-published Sleep in the Intensive Care Unit Questionnaire. In addition, we hypothesize that both neurocognitive performance and the Sleep in the Intensive Care Unit Questionnaire will improve during the multi-stage MICU-wide sleep QI project. Our project will provide valuable empirical evidence to help support guidelines for promoting sleep in the ICU setting.

Eligibility Criteria:
Inclusion Criteria:

* \>=18 years old
* Spent at least one full night (i.e. 7pm to 7am) in the Johns Hopkins Hospital (JHH) Medical Intensive Care Unit (MICU).
* Discharged directly from MICU to an in-patient medical step-down or ward bed at JHH.

Exclusion Criteria:

* Previously enrolled in the study (i.e. repeat discharge from MICU)
* Pre-existing cognitive impairment, including hepatic encephalopathy, long-term alcohol abuse, and neurological disease (e.g., dementia, prior stroke, cerebral palsy, traumatic brain injury, active seizures)
* Unable to speak and/or understand English
* \> 96 hours between MICU discharge and testing
* Visual or hearing impairment, inability to read, or inability to use a writing instrument preventing administration of the neurocognitive tests
* Spent at least one night in an ICU other than JHH MICU during current hospitalization
The Study to Reevaluate the Safety and Efficacy of Human Urinary Kallikrein

In order to reevaluate safety and efficacy of human urinary kallikrein in treating acute cerebral infarction ,a multi-center, open label , single group study was designed. Expect to enroll 60 sites and 2186 subjects. Subjects will receive kallikrein treatment according to real clinical practice (suggest above 14days treatment) and 90 days follow up


Eligibility Criteria:
Inclusion Criteria:

1. Acute anterior circulation cerebral infarction diagnosed ≤ 48h;
2. First time diagnosed or have history of acute anterior circulation cerebral infarction without serious sequelae(mRS=0-2);
3. Age from 18 to 80 years old;
4. National Institute of Health stroke scale(NIHSS) from 6 to 25;
5. Have provided signed written informed consent from the patient or the patient's legal representative.

Exclusion Criteria:

1. Brain CT shows cerebral hemorrhage disease: cerebral hemorrhage, subarachnoid hemorrhage, etc.
2. Transient ischemic attack(TIA);
3. Serious disturbance of consciousness: Glasgow Coma ScaleGCS（GCS）≤8;
4. Combined angiotensin-converting enzyme inhibitor(ACEI) less than 5 half-time(according to its instruction), or need to be treated with ACEI;
5. Cases treated with thrombolysis / stent surgery or expected to be treated with thrombolysis / interventional therapy / stent surgery.
6. subjects with bleeding disorders at Past or present, laboratory tests: INR \> 1.5 or APTT \> 2 times;
7. subjects with abnormal liver function (ALT/AST \> 1.5 \* ULN) and abnormal renal function (Cr\> normal upper limit);
8. subjects with history of epilepsy or other serious systemic disease before onset of AIS refused by PI to enroll ;
9. subjects with cardiogenic stroke or cardiogenic stroke related high-risk factors identified by PI, such as atrial fibrillation, echocardiography or Mural thrombus etc;
10. subjects diagnosised any malignancy (except basal cell carcinoma) within 5 years prior to the start of the study;
11. subjects with severe dementia or can't cooperate to evaluate identified by PI;
12. suffering from severe hypertension and failed to control :systolic blood pressure ≥200mmHg (26.6kPa) or diastolic blood pressure ≥110mmHg (14.6kPa); hypotension: systolic blood pressure\< 90mmHg and/or diastolic blood pressure\< 60mmHg
13. subjects be allergic or intolerant to kallikrein at past;
14. subjects be pregnant/lactating or possibly and planned pregnant;
15. subjects be unsuitable for this clinical study identified by PI.
Evaluation of the Relationship Between Serum Selenium Level and Glycemic Control in Pregnant Patients*

Gestational diabetes mellitus (GDM) occurs in approximately 15% of all pregnancies worldwide.GDM can lead to the development of type 2 diabetes mellitus (T2DM) later in a woman's life. Babies of mothers with GDM have a greater risk of developing T2DM and cardiovascular disease than infants of women without GDM. The degree of insulin resistance is directly proportional to the accumulated free radicals. Selenium functions as an active site component of an antioxidant enzyme, glutathione peroxidase, and helps scavenge free radicals. In addition, an experimental study has shown that selenium provides activation by binding to insulin receptors and lowers blood sugar by increasing glucose uptake by cells.

According to all this information, we aimed to evaluate the effect of selenium on blood sugar regulation in pregnant patients.

Pregnant patients with no known chronic disease / drug use and who had an oral glucose tolerance test between 24 and 28 weeks of gestation will be included in our study. The presence of one or more of the fasting blood glucose values ≥ 92, 1st Hour ≥ 180 and 2nd Hour ≥ 153 will be considered as gestational diabetes. Our patients diagnosed with gestational diabetes in the second step will be divided into two groups.

The first group will be started with diet only, the second group diet + 200 mcg selenium supplement per day. Patients will continue these treatments for 4 weeks, and at the end of 4 weeks, they will follow their fingertip blood sugar for 5 days (fasting, 1st hour satiety and 2nd hour satiety) while the treatment continues. In patients with gestational diabetes diagnosis, our targets for fingertip blood glucose follow-ups at home are fasting \<95, 1st hour \<140, 2nd hour \<120.

The 5-day measurements of both groups will be averaged for fasting, 1st Hour and 2nd Hour, and it will be evaluated whether there is a significant difference in blood sugar regulation between the groups that take selenium supplements and those that do not.

Eligibility Criteria:
Inclusion Criteria:

* Presence of one or more of the values of fasting blood glucose ≥ 92, 1st hour ≥ 180 and 2nd hour ≥ 153 among pregnant patients for whom we had an oral glucose tolerance test between 24 and 28 weeks of gestation
* single pregnancy
* 18 to 45 years old

Exclusion Criteria:

* chronic disease (thyroid dysfunction, acute/chronic liver disease, acute/chronic kidney disease, hypertension )
* Patients with a diagnosis of insulin resistance or diabetes
* Those who use drugs other than iron, vitamin D and multivitamin support
* multiple pregnancy
* patients under 18 years old
* Patients over 45 years old
Drug Wastage : Observational Study in Intensive Care Units in France

Environmental awareness leads medical field to question its responsibility and possibilities for action.

Drug residues can have a major environmental impact as per their bioaccumulation, toxicity and persistence characteristics, depending on where they are discarded. In France, drug residues should be disposed of by incineration, but in practice, this is not systematic. Moreover, data on drug wastage in Intensive Care Units (ICU) are rare.

GAME-OVER observational study aims to evaluate drug wastage in ICU in France and to suggest ways to improve health care practices.

Observational study with data collection during a 24-hour business day. Data collected refer to healthcare team's practices and patients.

Collection starts when day shift starts (at 7:00 am) and ends when night shift leaves (at 7:00 am the following day).

Eligibility Criteria:
Inclusion Criteria:

* Adult patients hospitalized in intensive care units during the 24 hours of data collection.

Exclusion Criteria:

* Patient's opposition to participate in the study or patient family opposition if the patient is not able to be informed.