cyrilzakka/clinical-trials huggingface dataset:
Effect of Intermittent Oro-esophageal Tube Feeding on Severe Traumatic Brain Injury Patient

This was a multicenter randomized controlled study of 98 severe Traumatic Brain Injury patients with tracheostomy. Patients enrolled were divided randomly into the observation group with Intermittent Oro-esophageal Tube Feeding or the control group with Nasogastric tube feeding for enteral nutrition support, respectively. Nutritional status, complications, decannulation of tracheostomy tubes and level of consciousness on day 1 and day 28 were recorded and compared.

The safe and effective nutrition support for severe traumatic brain injury patients with tracheostomy continues to be a challenge. Nasogastric tube feeding has been the mainstream choice in China but with the risk of complications. Intermittent Oro-esophageal Tube Feeding is an established modality of enteral nutrition support that can be used with routine treatment. This study reports the clinical outcomes of Intermittent Oro-esophageal Tube Feeding vs. nasogastric tube feeding, in patients receiving routine treatment. This was a multicenter randomized controlled study of 98 severe traumatic brain injury patients with tracheostomy. Patients enrolled were divided randomly into the observation group with Intermittent Oro-esophageal Tube Feeding or the control group with Nasogastric tube feeding for enteral nutrition support, respectively. Nutritional status, complications, decannulation of tracheostomy tubes and level of consciousness on day 1 and day 28 were recorded and compared.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years, meeting the diagnosis of severe Traumatic Brain Injury, confirmed through MRI
* score of Glasgow Coma Scale (GCS) \<8;
* presence of no contraindication for enteral nutrition;
* with stable vital signs and no severe liver or kidney dysfunction, metabolic disorders, cardiovascular diseases, or multiple complications;
* informed consent form was obtained from the patients' family members, indicating their full understanding of the study and agreement to participate.

Exclusion Criteria:

* unable to cooperate in completing treatment and assessment due to personal reasons or other disorders;
* complicated with other intracranial lesions, such as stroke;
* with severe consciousness disorders caused by other diseases.
Associative Peripheral Stimulation for Reduction of Motor Impairment During Acute Period of Stroke Recovery

Associative Peripheral Stimulation (APS) is a non-invasive therapy intended for stroke rehabilitation involving transcutaneous electrical muscle stimulation paired with voluntary movement. This pilot study investigates whether APS applied during the acute phase of stroke recovery may reduce impairment and improve function in the affected upper extremity.


Eligibility Criteria:
Inclusion Criteria:

1. Confirmed ischemic or hemorrhagic stroke no earlier than 7 days prior to enrollment;
2. Presentation of hemiparesis or paralysis of the upper extremity due to stroke;
3. Ability to comprehend and follow study instructions;
4. Ability to initiate finger extension (≥3°) at least three times per minute;
5. Fugl-Meyer Assessment (Upper Extremity) score of \<47.

Exclusion Criteria:

1. Contraindications, intolerance, or high sensitivity to the experimental protocol;
2. History of upper-extremity disability prior to the index stroke;
3. Neurological conditions (other than stroke) affecting motor function;
4. Treatment of spasticity/increased tone in the affected upper extremity (e.g., with Botox injection);
5. Lack of access to a safe and suitable place of discharge for experimental sessions and follow-up visits.
Adjuvant GVAX Vaccine Therapy in Patients With Pancreatic Cancer

This is an open label, phase II trial study of adjuvant GVAX pancreas vaccine in patients with pancreatic cancer.

Eligible participants will receive by intradermal administration the GVAX pancreas vaccine consisting of two irradiated allogeneic pancreatic tumor cell lines transfected with the granulocyte macrophage-colony stimulating factor (GM-CSF) gene.

There will be two cohorts of research participants:

1. Participants previously vaccinated with GVAX pancreas vaccine. These participants will receive booster vaccinations as a continuation of care. Vaccination repeats every 6 months in the absence of disease progression or unacceptable toxicity.
2. Participants who were not previously vaccinated with GVAX pancreas vaccine (vaccine naive). These participants received priming vaccinations once a month for 3 months followed by booster vaccinations every 6 months.

Eligibility Criteria:
1. Inclusion Criteria:

   A. previously vaccinated subjects must receive Gvax vaccine previously

   B. naïve and previously vaccinated subjects must meet the following criteria:
   * have a history of surgically resected pathologic stage 1,2 or 3 adenocarcinoma of the head, neck, tail, or uncinate of the pancreas
   * received the last anti-cancer therapy at least 28 days ago.
   * provide informed consent.
   * have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
   * have adequate hematologic function (Hemoglobin ≥ 9 gm/dl, Absolute neutrophil count (ANC) ≥ 1500 #/cu mm, platelets ≥100,000 K/cu mm)
   * have adequate renal function (Serum creatinine ≤ 2 mg/dL).
   * have adequate hepatic function (Bilirubin ≤ 2.0 mg/dL, unless known Gilbert's Syndrome; Aspartate Aminotransferase (AST), Alanine transaminase (ALT) and amylase ≤ 2x upper limit of normal: Alk Phosphatase ≤ 5x upper limit of normal.)
   * agree to use adequate birth control, if of childbearing potential.
2. Exclusion criteria:

   * radiographical evidence of pancreatic cancer disease recurrence
   * documented history of autoimmune diseases including systemic lupus erythematosus, sarcoidosis, rheumatoid arthritis, glomerulonephritis, or vasculitis
   * uncontrolled medical problems
   * systemic steroid therapy within 28 days before vaccine administration
   * anticipated need for systemic steroid therapy within 28 days after vaccine administration
   * evidence of active infections
   * pregnant
Vericiguat for Heart Failure With Reduced Ejection Fraction After Myocardial Infarction

The effects of vericiguat on cardiac remodeling in patients with chronic stable heart failure after myocardial infarction have not been reported. This project aims to clarify the efficacy and safety of vericiguat in patients with chronic heart failure after myocardial infarction. Patients with chronic stable heart failure with reduced ejection fraction after myocardial infarction in the electronic medical records of Qilu Hospital of Shandong University will be selected and divided into two groups: the treatment group received vericiguat in addition to conventional treatment and the control group received conventional treatment only. After 12-month treatment, the effects of vericiguat on cardiac remodeling and function and cardiovascular adverse events will be evaluated. The results are helpful to provide a new treatment strategy for chronic heart failure after myocardial infarction.


Eligibility Criteria:
Inclusion Criteria:

1. The history of acute myocardial infarction exceeds 3 months;
2. Symptoms and signs of heart failure have been stable for more than one month;
3. 18 years old or more;
4. NYHA cardiac function classified as grade II\~IV;
5. LVEF≤40%；
6. NT-proBNP≥450pg/ml；
7. All subjects or their guardians must sign the subject consent before entering the trial.

Exclusion Criteria:

1. Patients with the following diseases: nonischemic cardiomyopathy; valvular heart disease; congenital heart disease; obstruction of left ventricular outflow tract; severe decompensated heart failure; active myocarditis or pericardial disease; end-stage liver and kidney diseases; malignant tumor;
2. Mechanical complications of myocardial infarction;
3. Unable to obtain primary outcome data.
To Demonstrate Equivalence in Analgesic Efficacy & Bowel Function Between OXN PR Higher Dose & Lower Dose Tablet Strengths in Subjects With Non-cancer or Cancer Pain

This study is aimed to demonstrate equivalence between combinations of lower strength OXN PR tablets (OXN PR LST) and single higher strength OXN PR tablets (OXN PR HST) taken at the same overall daily dose.

Study OXN3508 is a multicenter double-blind, double-dummy, randomised, cross-over, 2-period, phase III study in male and female subjects with severe non-malignant or malignant pain that requires around-the-clock opioid therapy at a daily dose of 120/60 mg or 160/80 mg oxycodone/naloxone prolonged release (OXN PR).

Eligibility Criteria:
Inclusion Criteria

* Subjects who are receiving WHO step III opioid analgesic medication for the treatment of non-malignant or malignant pain.
* Documented history of non-malignant or malignant pain that requires around-the-clock opioid therapy

Exclusion Criteria

* Females who are pregnant or lactating.
* Subjects with evidence or significant structural abnormalities of the gastrointestinal tract.
* Subjects with evidence of impaired liver/kidney function upon entry into the study.
Exercise Intensity and Type 2 Diabetics

The purpose of this study is to determine if a single session of aerobic exercise effectively controls the blood pressure (BP) of individuals with type 2 diabetes mellitus (T2DM) over the 24h of post-exercise period, and the effects of intensity of aerobic exercise on these BP responses.


Eligibility Criteria:
Inclusion Criteria:

* sedentary
* a diagnosis of T2DM for at least one year
* glycemic control through nutrition and/or medication

Exclusion Criteria:

* be not under use of exogenous insulin and do not present chronic complications such as diabetic foot
* nephropathy
* retinopathy
* neuropathies and cardiovascular diseases
Complementary and Integrative Pain Therapies and Functional Restoration (IMPPPORT) Trial)

This study aims to evaluate the benefit of a complementary and integrative health (CIH) pain management program when added to standard rehabilitative care (SC) compared to SC alone prior to an intensive functional restoration (FR) program in a population of active duty service members. In addition the study aims to identify factors that predict improvement in pain impact following treatment, and to determine the proportion of participants who experience clinically meaningful response.

SC included physical and occupational therapy. CIH included chiropractic, acupuncture, yoga and foam roller instruction. Both treatment groups also received education about pain psychology.

Participants were randomly assigned to a 3-week course of either SC alone or CIH combined with SC prior to a 3-week course of FR. Outcomes were collected at baseline, at end of stage 1, and post-FR. Outcomes included patient-reported and provider-determined measures.


Eligibility Criteria:
Inclusion Criteria:

* Significant functional impairment due to pain, requiring modification of military duties.
* Physically able to participate in up to four hours of physical activity (strength, flexibility, endurance training) per day:

  1. Can stand up from and sit down on floor independently
  2. Can walk on treadmill for at least 6 minutes at 2.5 mile/hour pace or faster.
  3. Able to complete at least 2 of the following:

     1. Lift 20 lbs from floor to knuckle height
     2. Lift 20 lbs from floor to shoulder height
     3. Carry 20lbs at least 40 feet.
* Inadequate response to previous less intensive treatment
* Expresses motivation to take active role in regaining function

Exclusion Criteria:

* Major surgeries within past 6 months or planned within next 6 months
* Unstable psychological disorders
* Active substance use disorder
* High dose opioids of \>120 milligrams of morphine equivalent doses (MED)/day
Effects of Acupoint Massage Around Eyes on Ocular Biological Indexes

This study aims to investigate whether the acupoint eye exercise could impact the biological parameters of the eye.


Eligibility Criteria:
Inclusion Criteria:

* healthy people of all ages

Exclusion Criteria:

* presence of systemic diseases
* history of other eye diseases, surgeries, and/or medications, as well as eye trauma
* incomplete healing of the surgical site after eye surgery
* consumption of coffee, tea, or vasodilators within 6 hours before the commencement of the test
* exclusion of children, pregnant, and lactating women
Efficacy and Safety of Direct Oral Anticoagulants for the Treatment of Mural Thrombus

To describe the prescribing patterns at Methodist Dallas Medical Center (MDMC) for the treatment of newly diagnosed mural thrombus and to determine the efficacy and safety of DOACs apixaban, dabigatran, and rivaroxaban in comparison to warfarin.

With limited treatment guideline consensus, minimal evidence to support the use of DOACs for Left Atrial Appendage (LAA) thrombus and Left Ventricular Thrombus (LVT), and a lack of evidence for the use of DOACs in aortic thrombus, further research is warranted to determine the role of DOACs in the treatment of various mural thrombi in comparison to warfarin.

Retrospective chart review of MDMC patients from 4/1/2017 to 8/31/19 with newly diagnosed mural thrombus.

3.1. Study Methods

* Patients will be allocated into two groups: those who were prescribed DOACs upon discharge and those who were prescribed warfarin upon discharge
* Subgroup analyses will occur to evaluate the difference in efficacy and safety endpoints for patients into four categories including: those predisposed to mural thrombus by baseline risk factors (AFIB vs. ACS), location of the mural thrombus (atrial, ventricular, aortic), DOAC by agent (apixaban, rivaroxaban, dabigatran), and DOAC by scheduled dosing indication (AFIB vs. VTE).

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. MHS patients with newly diagnosed mural thrombus from 4/1/2017 to 8/31/19 identified by International Classification of Diseases (ICD) codes: I23.6, I240, I513, I7409, I7411, I7419, I82210, I82229

Exclusion Criteria:

1. Age \<18 years
2. Anticoagulant use at baseline (DOAC, LMWH, VKA)
3. Active cancer
4. Active bleeding
5. Pregnancy
6. Hospice or palliative care upon discharge
7. Warfarin that did not receive adequate bridging from parenteral anticoagulation
8. Non newly diagnosed mural thrombus
The Evaluation of Left Ventricular Systolic Function in Different Types of Ischemic Heart Disease

The study was designed to evaluate the left ventricular longitudinal strain and strain rate assessed by 2D-STI in patients with coronary microvascular dysfunction (CMD) or obstructive coronary artery disease (CAD) , to investigate the effect of different types of ischemic heart disease on the LV systolic function, and to explore the value of LS on the diagnosis of coronary microvascular dysfunction.

A total of 175 patients with chest pain, without wall motion abnormality and without significant coronary artery stenosis (\<50%) assessed by coronary angiography or coronary computed tomography were enrolled from July 2011 to December 2017. Coronary flow reserve (CFR) of these patients were detected by transthoracic Doppler echocardiography. The patients were divided into coronary microvascular dysfunction group ( CFR≤2.5, n=67) and control group (CFR\>2.5, n=108). At the same time, 67 age-matched patients with any major coronary arteries stenosis≥50% and without wall motion abnormality were involved into the obstructive coronary artery disease group. Parameters of global longitudinal strain (LS) and strain rate, subendocardial LS and subepicardial LS were quantified by 2D-STI, the differences of these parameters among three groups were analyzed，correlation analysis、univariate and multivariate analysis and receiver operating characteristic curve were used.

Eligibility Criteria:
Inclusion Criteria:

* age from 18-85 years

Exclusion Criteria:

* patients with history of myocardial infarction or abnormal wall motion suggested by conventional echocardiography
* patients with acute heart failure, chronic heart failure or LVEF values less than 50%
* patients with congenital heart disease, severe valvular disease, severe bradycardia, high atrioventricular block and atrial fibrillation
* patients who did not store ultrasound images or whose ultrasound images were unclear
* patients who had incomplete clinical data
Impact of CErebral Endovascular PROcedures on the Systemic Immune responSe Response

In our ICU, it could notice that patients with cerebral arterio-venous malformation (AVM) treated with embolization develop more severe Ventilator Associated Pneumoniae (VAP) compare to other patients hospitalized for neurological diseases. The Dimethylsulfoxyde (DMSO), the solvent of the embolization implant, is known to have immune effect on vitro analysis. The investigator want to prove that exposition to embolization implant for a cerebral AMV modify the cytokines production involved the system immune's regulation.

Cerebral AVM are defined by abnormal connections between arteries and veins. For treatment of this vascular malformation, embolization is the gold standard. Embolization agent is made with vinylic alcohol ethylene (EVOH) copolymer which (the embolization implant) and the DMSO which is the solvent. During the injection of the product, DMSO dissipates in the bloodstream, and the EVOH precipitates and forms the embolus. It knows that DMSO had in-vitro immune effect (inhibits signalizations ways of innate and acquired immune response, decrease of pro-inflammatory cytokines production and decrease INF-γ and TNF-α production). DMSO could decrease activation and recruitment of leukocytes, which could expose patients to an increased risk of infection.

The investigator will dose cytokines in 3 blood samples (preoperative, H+6 and H+24) in planned patient's hospitalized for cerebral AVM embolization. The cytokine content of the plasmas will be analyzed with multiplex ELISA technic

Eligibility Criteria:
Inclusion Criteria:

* Adult hospitalized for a planned cerebral embolization

Exclusion Criteria:

* Immunosuppressed patient or immunosuppressive treatment (corticosteroid included)
* Patient with auto-immune disease
* Hospitalization in ICU or for a planned or emergency surgery in the past three months
* Hospitalization for an active infection in the past three months
* Pregnancy
* Patients requiring steroid therapy to prevent postoperative nausea and/or vomiting
HIT in People With Type 1 Diabetes

Few people with type 1 diabetes achieve exercise guidelines and many programmes designed to increase physical activity have failed. High-intensity interval training (HIT) has been shown to be a time-efficient alternative to traditional moderate-intensity continuous training (MICT) in various groups without type 1 diabetes. A single bout of HIT does not increase the risk of hypoglycaemia in people with type 1 diabetes. This study aimed to assess whether HIT a safe, effective and time-efficient training strategy to improve cardio-metabolic health and reduce the risk of hypoglycaemia in people with type 1 diabetes.

This study aimed to investigate whether 1) six weeks of high-intensity interval training (HIT) induces similar improvements in cardio-metabolic health markers as moderate-intensity continuous training (MICT) in people with type 1 diabetes, and 2) whether HIT abolishes acute reductions in plasma glucose observed following MICT sessions. Fourteen sedentary individuals with type 1 diabetes (n=7 per group) completed six weeks of HIT or MICT 3 times per week. Pre- and post-training measurements were made of 24h interstitial glucose profiles (using continuous glucose monitors (CGMS)) and cardio-metabolic health markers (V ̇O2peak, blood lipid profile and aortic pulse wave velocity; aPWV). Capillary blood glucose concentrations were assessed before and after exercise sessions throughout the training programme to investigate changes in blood glucose during exercise in the fed state.

Eligibility Criteria:
Inclusion Criteria:

* duration of type 1 diabetes \>6 months
* basal bolus regimen
* no significant history of hyper- or hypoglycaemia (determined from medical history)

Exclusion Criteria:

duration of type 1 diabetes \<6 months,

* insulin pump therapy
* significant history of hyper- or hypoglycaemia (determined from medical history)
* obesity (BMI \>30 kg∙m-2)
* pregnancy or planning pregnancy
* uncontrolled hypertension (\>180/100 mmHg)
* angina, autonomic neuropathy
* taking any medication that affects heart rate
* major surgery planned within 6 weeks of the study
* severe nonproliferative
* unstable proliferative retinopathy
Optimal Blood Pressure Treatment Thresholds Postpartum

The objective of this research project is to conduct a single-site pilot trial within our institution's clinical remote blood pressures (BP) management program to assess the feasibility and effect of tight blood pressure control versus usual care in the immediate postpartum period after a hypertensive disorder of pregnancy (HDP).

The investigators' central hypothesis is that tight blood pressure control will be feasible and acceptable to postpartum individuals and will result in lower BP at six months postpartum and a reduction in postpartum hospital readmissions. Subjects will undergo 3 study visits (1 in-person and 2 remote) involving BP measurements, blood draws, and/or questionnaires. Up to 60 adult subjects will be enrolled at Magee-Women's Hospital.

The investigators will determine the feasibility of conducting a randomized controlled trial of tight blood pressure control (\<135/85 mmHg on home BP monitoring) vs. standard of care (\<150/100 mmHg on home BP monitoring) in postpartum individuals following a HDP with assessment of individuals who are eligible, enrolled, and remain in the study until six weeks postpartum. Individuals who are retained in the study for 6 months postpartum. Lastly, investigators will analyze effect outcomes to inform the sample size for a subsequent large-scale randomized trial. This will be done through analysis of mean arterial pressure (MAP), systolic blood pressure, and diastolic blood pressure of participants at 6 weeks and at 6 months postpartum. The study will be conducted on the postpartum unit of Magee-Womens Hospital. Participants will be enrolled at the time of postpartum hospitalization with study visit #1 occurring in the hospital. At this study visit, participants will be administered questionnaires, will provide a blood sample, and BP will be measured. Study visit #2 will be a remote study visit conducted via telemedicine or a telephone call at 6 weeks postpartum. At this visit, participants will provide questionnaires and blood pressure data. Study visit #3 will be a remote study visit conducted via telemedicine or a telephone call at 6 months postpartum. At this visit, participants will again provide questionnaires and blood pressure data.

Eligibility Criteria:
Inclusion Criteria:

* Postpartum individuals ≥18 years old
* Preeclampsia or gestational hypertension diagnosis (complying ACOG criteria)
* Enrolled in remote BP management program.

Exclusion Criteria:

* Pre-pregnancy hypertension
* Pre-pregnancy diabetes
* Maternal cardiac disease
* Chronic kidney disease