cyrilzakka/clinical-trials huggingface dataset:
Clinical Use of a Neonatal MRI System

The purpose of the present study is to continue clinical scanning on the NICU MRI with improved administrative processes and procedures, thereby making medically indicated, state of the art/high end MRI exams available to all infants treated at CCHMC.

There are significant safety and image quality issues associated with transferring neonates from the Neonatal Intensive Care Unit (NICU) to the main Radiology Department for imaging in an adult-sized magnetic resonance imaging (MRI) scanner. For these reasons, the smallest and/or sickest neonates are typically precluded from receiving an MRI exam. The goal of our research effort is to bring high-performance MRI into the NICU so that all neonates can benefit from the same quality of diagnostic imaging as adults. To accomplish this, we have converted a commercial small-bore 1.5 Tesla (T) MRI scanner designed for orthopedic use into a neonatal MRI system optimized for whole body imaging of neonates (NICU MRI). To expand the imaging capabilities of the NICU MRI system, the measurement control electronics and operating system software of the FDA cleared OPTIMA platform have been augmented with state of the art HDX electronics and software currently used on a conventional commercially available adult sized whole body MRI scanner. The clinical safety of the integrated HDX/OPTIMA NICU MRI system and its ability to produce diagnostic image quality has been shown in 15 pilot patients (CCHMC Protocol 2011-2045). Further we have scanned almost 600 patients under a prior protocol (CCHMC Protocol 2011-2850) without an adverse event.

The present protocol seeks to allow continued performance of clinical MRI exams on the NICU magnet with improved administrative processes and procedures. NICU patients for whom an MRI exam is medically indicated will be recruited for the present study. Images will be obtained using both the FDA cleared OPTIMA NICU MRI platform and the integrated HDX/OPTIMA NICU MRI platform with the additional HDX images augmenting the OPTIMA images and contributing to diagnosis and guidance of subsequent clinical management. The specific MR imaging methods/procedures utilized will be determined by the type of exam to be performed and the medical indication. All of the MR images obtained will be reviewed by a board certified pediatric radiologist as part of clinical care and a clinical report will be generated and included in the infant's medical record.

Eligibility Criteria:
Inclusion Criteria:

* Any infant admitted to CCHMC
* Have a medical condition for which an MRI exam is indicated, as determined by the attending neonatologist

Exclusion Criteria:

* Infants too large to fit in the customized NICU MRI system comfortably (generally infants \> 6 kg)
* Standard MRI exclusion criteria as set forth by the CCHMC Division of Radiology
Clinical Research on Teratment of Gastrointestinal Cancer in the Preoperative by Propranolol

To research the effect of propranolol on the proliferation and apoptosis of gastrointestinal cancer.


Eligibility Criteria:
Inclusion Criteria:

1. patients with gastric adenocarcinoma and colon cancer were diagnosed by histology and cytology, and there was a clear metastasis (TxNxM0);
2. without any prior treatment (including surgery or radiotherapy and chemotherapy) in the I-III period, no distant metastasis, suitable for patients with surgical resection of the tumor.
3. the age range of the patients is 18-60;
4. systolic pressure 100-140mmHg; heart rate \>60bpm;
5. the patient's survival time should be longer than 3 months;
6. without previous cardiovascular and cerebrovascular diseases, the atrioventricular block was excluded by the 24 hour dynamic electrocardiogram;
7. ECOG score of 2 (that means the patient's bed time is less than 50%); Karnofsky score of 60% (that means patients have the basic activities and self-care ability);
8. the basic biochemical examination results of patients with normal: white blood cell 3000/ul; neutrophil 1500/ul 100000/ul; platelet count; total bilirubin \< 1.5 x ULN; AST / ALT 2.5 x ULN without liver metastasis; \< 5 x ULN liver metastasis; creatinine clearance rate of 1.5 x ULN;
9. have the ability to understand and sign informed consent.

Exclusion Criteria:

1. pregnant or lactating women;
2. patients with severe heart disease, kidney disease, metabolic disorders, bronchial asthma, cardiogenic shock, heart block (II-III degree atrioventricular block), or severe acute heart failure, sinus bradycardia.
3. patients with epilepsy or psychotropic drugs and sedatives;
4. patients with brain metastasis and bone marrow metastasis;
5. participants in clinical trials of other drugs within 4 weeks;
6. patients with a history of anaphylaxis with propranolol;
7. patients treated with trastuzumab;
8. patients with or reactive immunodeficiency, such as those with HIV infection;
9. the uncontrollable situation in the group during the period (but not limited to these cases): according to the experimental scheme of medication, severe infection, due to mental illness or other social factors lead to the compliance requirements of patients;
10. patients with atrioventricular block should be discontinued immediately and quit;
11. the researchers believe there may be any increase in the risk of the subject or any interference with clinical trials.
The Effects Of Whole Body Vibration On Postural Control In Patients With Ataxia

To investigate the effects of whole body vibration on postural control and on the level of satisfaction regarding how to reach the goals of the patients with ataxia

Patients will be randomly assigned to 2 groups, group 1 will take only exercise therapy, group 2 will take exercise therapy and whole body vibration together. After 1 week wash-out period, patients assigned other therapy period. All assessments will be repeated before and after each therapy period. Exercise therapy will consist of selected balance, coordination and walking exercises according to the individual needs of patients. Whole body vibration (20-30 Hz, minimum amplitude) will be applied to cases in the form of 4 sets (1 min application and 1min rest.) Cases will take the treatment 1-hour, 3 days in a week for 8 weeks.

The evaluation parameters consists of demographic information, Computerized Dynamic Posturography, International Cooperative Ataxia Rating Scale, Trunk Impairment Scale, Berg Balance Scale, Barthel Index and Goal Assessment Scale.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of ataxia
* Ataxic patients who are able to walk 25 m independently

Exclusion Criteria:

* Clinical diagnosis of systemic problems (Diabetes Mellitus, Hypertension)
* Clinical diagnosis of cognitive impairment
A Study of 2-dose Vaccine Regimen Using 3 Consecutive Lots of Ad26.ZEBOV and MVA-BN-Filo in Adult Participants

The purpose of this study is to demonstrate that the paired 2-dose vaccine regimens from 3 consecutively manufactured lots of Adenovirus serotype 26 encoding the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) as Dose 1 and 3 consecutively manufactured lots of Modified Vaccinia Ankara Bavarian Nordic vector encoding multiple filovirus proteins (MVA-BN-Filo) including the ebola virus mayinga glycoprotein as Dose 2, administered at a 56-day interval, induce an equivalent humoral immune response.


Eligibility Criteria:
Inclusion Criteria:

* Signed an informed consent form (ICF)
* Medically stable in the investigator's clinical judgment on the basis of physical examination, medical history, and vital signs performed at screening
* Before randomization, a woman must be either: a. Not of childbearing potential; b. Of childbearing potential and practicing an acceptable effective method of birth control and agrees to remain on such a method of birth control from signing the informed consent form (ICF) until at least 3 months post Dose 1 vaccination or 28 days post Dose 2 vaccination or 3 months post booster vaccination (Groups 5-6 only), whichever comes later. Use of hormonal contraception should start at least 28 days before the first administration of study vaccine. Acceptable effective methods for this study include: 1) hormonal contraception; 2) intrauterine device (IUD); 3) intrauterine hormone-releasing system (IUS); 4) male or female condom with or without spermicide; 5) cap, diaphragm, or sponge with a vaginal spermicide; 6) vasectomized partner (the vasectomized partner should be the sole partner for that participant); 7) sexual abstinence
* Women of childbearing potential must have a negative urine Beta-human chorionic gonadotropin (Beta-hCG) pregnancy test at screening and immediately prior to each study vaccine administration
* Available and willing to participate for the duration of the study and follow-up visit
* Willing to provide verifiable identification

Exclusion Criteria:

* Having received any candidate Ebola vaccine
* Diagnosed with Ebola virus disease (EVD), or prior exposure to Ebola virus, including travel to an area with Ebola outbreak less than 1 month prior to screening (if applicable)
* Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine products (including any of the constituents of the study vaccines), including known allergy to egg, egg products, and aminoglycosides
* Presence of acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature greater than or equal to (\>=) 38.0ºCelcius on Day 1. Participants with such symptoms will be excluded from enrollment at that time but may be rescheduled for enrollment at a later date
* Human immunodeficiency virus (HIV) type 1 or type 2 infection, based on the medical history reported by the participant
* Pregnant, breast-feeding
* History of an underlying clinically significant acute or chronic medical condition
Hemodynamic Management in Women With SHS

Supine hypotensive syndrome often occurs following spinal anesthesia for cesarean delivery.In our study we base the regulation and drug administration both on the regular monitor and on a novel monitor which reflects upon the hemodynamic changes. Our aim is to observe whether the outcome of SHS patients with anesthesia management based on hemodynamic figures differs from those based on experience.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) Physical Status Classification II and had no significant cardiovascular, pulmonary, renal or endocrine disease, without contraindications to CSEA,and could be diagnosed as SHS according to the criteria.

Exclusion Criteria:

* Patients undergoing emergency CD, CD under general anesthesia or patients' refusal to participate, or multiple fetations.
Dose-finding Study of QGE031 as add-on Therapy to Evaluate Efficacy and Safety in Patients With CSU

This is a placebo and active-controlled phase 2b dose-finding study to evaluate efficacy and safety of QGE031 monthly subcutaneous injections as add-on therapy in patients with Chronic Spontaneous Urticaria.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic spontaneous urticaria for at least 6 months
* Diagnosis of chronic spontaneous urticaria refractory to standard of care at time of randomization

Exclusion Criteria:

* Clearly defined underlying etiology for chronic urticaria other than chronic spontaneous urticaria
* Evidence of parasitic infection
* Any other skin disease with chronic itching
* Previous treatment with omalizumab or QGE031
* Contraindications to or hypersensitivity to fexofenadine, loratadine, cetirizine, or epinephrine
* History of anaphylaxis
* History or current diagnosis of ECG abnormalities indicating significant risk of safety for patients participating in the study
* History of hypersensitivity to any of the study drugs or its components of similar chemical classes
* Pregnant or nursing (lactating) women

Other protocol defined inclusion/exclusion criteria may apply.
microRNA of Human Epidermal Growth Factor Receptor 2 （HER2）Positive Patient Treated With Herceptin

This projective observational study is planned to enroll more than 300 advanced breast cancer patients, who were proved as Her-2 positive using fluorescence in situ hybridization (FISH) and / or immunohistochemistry, and 100 healthy donors as control. Before treatment, the plasma microRNA will be collected and detected by microRNA extraction kit and quantitative polymerase chain reaction (qPCR), respectively. After analyzed their microRNA expression by microRNA predictive model, previously reported by our team, all of enrolled patients will be classified as "probable sensitive group" or "probable resistant group". Herceptin combined with other chemotherapy will be the backbone of salvage treatment and used for at least 3 months; the change of local masses and metastasis lesions after treatment will be documented to evaluate the response. Based on these results, investigator aim to construct a mathematical predictive model by analyzing the correlation of baseline microRNA expression level and the prognosis of patients. And a diagnosis microRNA kit will be planned and manufactured


Eligibility Criteria:
Inclusion Criteria:

1. The patients signed the written informed consent
2. female patient who is ≥ 18yrs,
3. HER2 positive: immunohistochemistry (+++) or FISH (+)
4. stage IV
5. the patients have no history of chemotherapy ,hormone therapy,radiotherapy or surgery after diagnosis of breast cancer
6. the result of patients' blood tests are as follow: WBC≥3.0×109/L; Plt≥100×109/L;AST/SGOT or ALT/AGPT≤tripple of normal upper limit; Creatinine\<double of the normal upper limit
7. ECOG scores are 0 or 1 .
8. The patient is able to take oral pills

Exclusion Criteria:

1. The patient was never exposed to herceptin.
2. The patient suffered from other non-breast malignancy in the last 5 years, except for cervical carcinoma in situ, radical basal cell carcinoma or squamous cell carcinoma.
3. The life expectancy is less than 3 months.
4. Severe hepatic function disorder, Child Pugh grade C.
5. Severe cardiac function disorder, cardiac function is more than grade III;
6. Prolonged QT interval;
7. Arrhythmia or taking anti-arrhythmia drugs;
8. Pregnant or breast feeding female.
Duration of Analgesia After Popliteal Fossa Nerve Blockade: Effects of Dexamethasone and Buprenorphine

Patients scheduled to go home after ankle surgery at HSS typically receive a sciatic nerve block in the popliteal fossa and oral analgesic tablets (such as Percocet). Popliteal fossa nerve blockade has reduced pain for these patients (YaDeau et al, Anesth Analg 2008;106:1916-20), but unfortunately the patients still often experience moderate to severe pain after the block wears off. The investigators wish to study two additives that may prolong the period of analgesia provided by the nerve block. The additives will be studied in the context of a standardized postoperative multimodal analgesic pathway.

Primary outcome:

Does adding dexamethasone and / or buprenorphine prolong the analgesia provided by a popliteal fossa nerve block?


Eligibility Criteria:
Inclusion Criteria:

1. Patients of Dr Levine or Dr Roberts.
2. Scheduled for discharge from HSS after foot or ankle surgery.
3. A single-injection popliteal fossa nerve block is judged appropriate.
4. Surgery confined to foot and ankle (no iliac crest bone graft planned - iliac aspirate is not an exclusion criterion).
5. Patients aged 18-75 years.

Exclusion Criteria:

* Surgery that will cause pain at sites outside the distal lower extremity (e.g. iliac crest bone graft).
* Bilateral surgery
* Chronic pain (defined as regular use of opioid analgesics for \> 3 months).
* Chronic use of steroids (defined as regular use of steroids for \> 3 months).
* Contraindication to performance of the popliteal fossa nerve block with 30 cc 0.25% bupivacaine with clonidine (e.g. alleged bupivacaine sensitivity, low body weight, clonidine allergy, etc.).
* Contraindications to dexamethasone or buprenorphine (e.g. allergy, Insulin Dependent Diabetes Mellitus, etc.)
* Inability of the patient to describe postoperative pain (e.g. psychiatric disorder, dementia).
* Non-English speaking patients (the questionnaire is in English, and translations would have to be separately validated)
Randomized Trial of COBRA PzF Stenting to Reduce Duration of Triple Therapy

The purpose of this study is to determine whether patients undergoing coronary intervention that also require oral anticoagulation, treatment with the COBRA PzF stent plus 14-day dual anti-platelet therapy (DAPT) has higher safety and non-inferior outcomes for thrombo-embolic events than compared with standard FDA-approved drug eluting stent (DES) plus 3 or 6-month DAPT.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than age 18 with ischemic symptoms (stable or unstable angina or NSTEMI without thrombosis of the target lesion on coronary angiography) or evidence of myocardial ischemia in the presence of ≥ 50% de novo stenosis located in native coronary vessels (max. 2 lesions in one or 2 separate vessels).
* Patient receiving or with an indication for new treatment with long-term oral anticoagulation with a coumadin derivatives or non-vitamin K oral anticoagulants.
* Written, informed consent

Exclusion Criteria:

* Cardiogenic shock
* Target lesion located in left main trunk
* Bifurcation interventions with a planned 2-stent strategy
* Vessel size too small for implantation of a 2.5 mm stent by visual estimation
* Patient requiring staging PCI procedure within 6 months after the index procedure
* Patients requiring DAPT for more than 2 weeks after the index procedure
* Contraindications or allergy to cobalt, chromium, platinum, polyzene-F, everolimus, zotarolimus or the inability to take triple therapy for at least 6 months
* Relevant hematologic deviations: platelet count \<100x10\^9 cells/L or \>600x10\^9 cells/L
* Active bleeding; bleeding diathesis; recent trauma or major surgery in the last month; history of intracranial bleeding or structural abnormalities; suspected aortic dissection
* Malignancies or other co-morbid conditions with life expectancy less than 12 months or that may result in protocol non-compliance
* Pregnancy, present (positive pregnancy test), suspected or planned, breast feeding
* Known allergy or intolerance to the study medications: ASA, clopidogrel, coumadin and its derivatives
* Patient's inability to fully cooperate with the study protocol
Effect of NPH Insulin, Insulin Detemir and Insulin Glargine on GH-IGF-IGFBP Axis

The objective is to describe the interaction of equal doses of NPH insulin (Neutral Protamine Hagedorn), insulin Detemir and insulin glargine on IGFBP-1 (Insulin-like Growth Factor Binding Protein-1) production as well as immunoreactive and bioactive IGF-I (Insulin-like Growth Factor-I) after once-daily injection on three separate visits in type 1 diabetic subjects.

Because of the importance of receptors activation and potential effects on the IGF system, a head-to-head comparison of the eventual differential impact of intermediate-acting human insulin (NPH), insulin detemir and insulin glargine on the growth hormone-insulin-like growth factor-insulin-like growth factor binding protein (GH-IGF-IGFBP) axis is relevant to be conducted for the safety assurance of insulin analogues. Therefore, this study aims to investigate whether the serum insulin profile obtained by once-daily injection of long-acting insulin analog, insulin detemir or insulin glargine, has a different impact on IGFBPs production and IGF-I concentrations (total IGF-I) bioactivity and tissue-availability as compared to that seen during treatment with intermediate-acting human insulin, NPH insulin.

Eligibility Criteria:
Inclusion Criteria:

1. Informed consent obtained before any trial-related activities.
2. Diagnosis of diabetes mellitus according to WHO criteria; history and clinical course consistent with type 1 diabetes mellitus.
3. Diagnosed with diabetes for more than 6 years and using continuous subcutaneous insulin infusion (CSII) at least 6 months at time of inclusion.
4. Total daily insulin dose between 0.4 and 1.4 units/kg (both values included)
5. HbA1c between 6% and 9% (both values included).
6. Age ≥ 18 years.
7. BMI between 18.5 and 28 kg /m2 (including both values).

Exclusion Criteria:

1. Known or suspected allergy to trial product(s) or related products.
2. Recurrent major hypoglycaemic episodes.
3. Heart: Unstable Angina Pectoris, AMI \< 12 months or heart insufficiency classified according to NYHA III-IV
4. Blood Pressure: Severe uncontrolled hypertension with BP \> 180/110 mmHg, sitting
5. Liver: Impaired hepatic function corresponding to serum-ALAT or basic phosphatase \> 2 x upper reference limit of the local laboratory.
6. Kidneys: Impaired renal function corresponding to serum-creatinin \> 150 μmol/l according to the local laboratory.
7. Any disease judged by the investigator to affect the trial.
8. Pregnancy, breast-feeding or the intention of becoming pregnant or fertile women not using adequate contraceptive measures - adequate contraceptive method is sterilisation, hysterectomy or current use of contraceptive pills or intra uterine device.
A Clinical Trial to Evaluate the Detection of Atrial Fibrillation for an One Day Versus More Than or Equal to Eight Days Using MEMO Patch PLUS in Individuals Aged ≥ 75 Years, or Those at High Risk of Stroke

The purpose of this study is to evaluate the benefits in the atrial fibrillation detection rate of the continuous ECG monitoring group for more than 8 days by contrasting with one-day ECG monitoring using MEMO Patch PLUS in 1000 patients with atrial fibrillation-related symptoms in the high risk group of stroke. The participant is allocated randomly to One-day ECG monitoring group or the continuous ECG monitoring group for more than 8 days in ratio of 1:1, only if the participant provides informed consent and eligible for all the inclusion/exclusion criteria. The investigator confirms the results of MEMO Patch PLUS monitoring at 1 month from the date of MEMO Patch PLUS attachment. The participation of the subject is terminated on the 1 year from the date of MEMO Patch PLUS attachment. On that day, investigator evaluates incidence of the event associated with atrial fibrillation, the event is included ischemic stroke/transient ischemic accident, hemorrhagic stroke, systemic embolism, etc.


Eligibility Criteria:
\[Inclusion criteria\]

A participant will be eligible for inclusion in the study if the participant:

1. Has provided documented informed consent for the study.
2. Is adult at least 19 years of age on the day of providing documented informed consent
3. Is the high risk group for stroke, i.e. adult at least 75 years of age or CHA2DS2-VASc score more than 2
4. Is life expectancy more than 6 months
5. Has no Atrial fibrillation or Atrial flutter as a result of 12-lead ECG
6. Has symptoms associated with Atrial fibrillation \*symptoms associated with Atrial fibrillation: palpitation, dizziness, dyspnea, syncope, stroke/transient ischemic accident, systemic embolism etc.

\[Exclusion criteria\]

The participant must be excluded from the study if the participant:

1. Has had prior history of Atrial fibrillation or Atrial flutter
2. Has received prior or ongoing anticoagulant or antiplatelet therapy
3. Has inserted Pacemaker or Defibrillator that can diagnose Atrial fibrillation or Atrial flutter
4. Has plan of Carotid endarterectomy or inserting Stent\* within 90 days on the day of providing document informed consent \*Stent insertion: means when stent-related interventions have been performed on the carotid arteyr or coronary arteries.