cyrilzakka/clinical-trials huggingface dataset:
The Metabolic Effect of Walnut Consumption in Healthy Men and Healthy Postmenopausal Women

The objectives of the proposed study are to assess the effect of walnut consumption on parameters of lipid metabolism, glucose metabolism, incretins and adipokines, endothelial function and blood pressure in healthy men and healthy postmenopausal women


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal healthy women and healthy men
* Age \> 50 yrs

Exclusion Criteria:

* Evidence of alcohol, tabacco or drug abuse
* Obesity ≥ 35 kg/m2
* Diabetes mellitus
* Hypertension
* LDL-cholesterol \> 190 mg/dl, Triglycerides \> 350 mg/dl
* History of atherosclerotic disease
Utilizing of Physiological Parameters Predict the Prognosis of Cirrhotic Patients With Gastrointestinal Bleeding

Can physiological indicators such as quick Sequential Organ Failure Assessment , Shock Index, and its derived indicators such as Modified Shock Index , Age Shock Index and Respiratory Adjusted Shock Index accurately predict the prognosis of cirrhosis patients with gastrointestinal bleeding? To explore the improvement of emergency and critical care patient management.

Cirrhosis is a common chronic liver disease with gastrointestinal bleeding being one of its complications. Gastrointestinal bleeding is quite common in patients with cirrhosis, but its prognosis is difficult to accurately predict. In current clinical practice, critical care physicians often use physiological indicators to assess the risk level of patients. Among them, the Shock Index and its derived indicators such as the Modified Shock Index, Age Shock Index, and Respiratory Adjusted Shock Index have been widely used in other fields, but their actual value in patients with cirrhosis complicated by gastrointestinal bleeding is not yet clear.

The prognosis of cirrhosis patients with gastrointestinal bleeding affects the quality of life and survival of the patients, thus necessitating the establishment of a reliable prognostic assessment tool to assist critical care physicians in making rapid treatment decisions. The motivation of this study is to explore the application value of Shock Index-related indicators in predicting the prognosis of cirrhosis patients with gastrointestinal bleeding, in order to improve the medical efficiency for this specific group of critically ill patients.

Eligibility Criteria:
Inclusion Criteria: cirrhosis with gastrointestinal bleeding -

Exclusion Criteria: no complete medical record and trauma patient

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Diffusion MRI in Cervical Spondylotic Myelopathy (CSM)

Patients who have been diagnosed with Cervical Spondylotic Myelopathy will be asked to undergo an MRI using diffusion basis spectrum imaging (DBSI) technology. The patients will have this MRI preoperatively and at 24 months postop. The investigators believe that with this imaging, biomarkers will be able to be seen to assist in prediction of long term outcomes in patients with spinal cord compression. These patients will be compared to healthy cohorts who will also undergo an MRI using the DBSI technology.

CSM is the most common form of spinal cord injury and is the leading cause of progressive disability in patients over the age of 65. A major shortcoming limiting the clinical management of CSM is the lack of quantifiable metrics to 1) base clinical decisions and 2) predict potential for functional recovery following surgical intervention. DBSI MRI will provide imaging biomarkers to more reliably predict a patient's clinical course, response to therapy, and long-term prognosis.

Patients who are diagnosed with CSM will have an MRI using the DBSI technology preoperatively and at 24 months. Surgical patients will be assessed with the Neck Disability Index (NDI), Disability of the Arm, Shoulder and Hand (DASH), hand grip dynamometer and Manual Muscle Testing (MMT), the modified Japanese Orthopaedic Association scale (mJOA), and the Major Depression Inventory (MDI), the Short Form-36 (SF-36) and Nurick scoring.

A control group of healthy volunteers will have an MRI using the DBSI technology when enrolled and then again between 12-24 months later.

Eligibility Criteria:
Inclusion Criteria:

* History of ongoing spinal cord compression,
* clinical evidence of CSM as determined by signs and symptoms including, but not limited to loss of manual dexterity, extremity weakness, sensory abnormalities, quadriparesis, loss of proprioception, and positive Babinski's or Hoffman's sign.

Exclusion Criteria:

* pregnant
* having an MRI incompatible device
* having a known diagnosis of amyotrophic lateral sclerosis, multiple sclerosis, rheumatoid arthritis, concomitant thoracic and/or lumbar stenosis, spine tumor or HIV-related myelopathy and having systemic instability or being deemed unable to tolerate standard MRI sequencing.
Inova Cardiogenic Shock Registry (INOVA SHOCK)

To collect retrospective clinical outcomes related to acute decompensated heart failure cardiogenic shock, acute myocardial infarction cardiogenic shock and compare current versus historical survival rates.

To collect Inova Heart and Vascular Institute (IHVI) site specific outcomes before and after initiation of the Cardiogenic Shock team on January 1, 2017.

To collect outcomes related to implementation of mechanical circulatory support versus no circulatory intervention and type of intervention (extracorporeal membrane oxygenation (ECMO) versus intracorporeal axial-flow (Impella).

• Assess survival at three time points.

Any patient with cardiogenic shock, whether inpatient or transferred from another facility, treated at the Inova Heart and Vascular Institute shall be included in this registry. This includes adults with and without decision making capacity over the age of 18 years old.

The primary investigator (PI) will designate the data points to be included in the database in order to assess the efficiency of procedures and protocols in the treatment of cardiogenic shock at the IHVI as administered by the Shock team, to identify relationships between treatment and negative morbidity and mortality outcomes, and to monitor and improve quality of care delivered.

Eligibility Criteria:
Inclusion Criteria:

-Patients at the IHVI with documented Cardiogenic Shock team intervention for acute decompensated heart failure cardiogenic shock, or acute myocardial infarction cardiogenic shock.

Exclusion Criteria:

-Patients under the age of 18 will be excluded.
Implication of Left veNtricle Vortex Flow Guided aNticOagulation Therapy for preVenting Apical Thrombus Formation In Patients With Acute myOcardial infarctioN: Multicenter Prospective Randomized Clinical Trial; INNOVATION Study

Implication of left veNtricle vortex flow guided aNticOagulation therapy for preVenting Apical Thrombus formation In patients with acute myOcardial infarctioN: Multicenter Prospective Randomized Clinical Trial; INNOVATION study


Eligibility Criteria:
Inclusion Criteria:

1. Patient is ≥ 30 years old
2. Acute anterior wall myocardial infarction showing akinetic or dyskinetic apical wall motion abnormalities on an initial transthoracic echocardiogram
3. Left ventricular ejection fraction less than 40%

Exclusion Criteria:

1. Prior history of myocardial infarction
2. Chronic medication with Coumadin
3. Contraindication of contrast echocardiography
4. Significant atrial or ventricular arrhythmia
5. Valvular heart disease more than moderate degree
6. Decompensated heart failure
7. Very poor echo window, which cannot evaluate the presence of apical thrombus
Clinic Study of 18F-Al-NOTA-MATBBN in Cancer Diagnostics

The purpose of this study is to determine whether 18F-Al-NOTA-MATBBN is safety and effective for cancer diagnosis.

Observe radiation dose to healthy volunteers and patients; the correlation between integrin level and tumor/metastases uptake.

Eligibility Criteria:
Inclusion Criteria:

1. Volunteers or patients with age more than 18 yeas;
2. The patients have been diagnosed with cancer or suspected with cancer;
3. It must fulfill the ethical requirements and subjects have signed an informed consent.

Exclusion Criteria:

1. Pregnancy or nursing mothers;
2. Having drugs or alcohol dependence;
3. Hypersensitive to the active or inactive ingredients of the study drug;
4. Having attended other drug clinical trials within three months;
5. Cardiac functional insufficiency;
6. Hepatic and renal function insufficiency;
7. Hypertensive patients with serious complications;
8. Endangering the safety of life.
Phase I Safety and Tolerability Study of Cediranib (RECENTIN™, AZD2171) in Combination With Chemo in First Line Lung Cancer Patients

This study is to assess the safety and tolerability of Cediranib (RECENTIN™, AZD2171)in combination with etoposide and cisplatin (EP) as first line treatment for lung cancer patients with extensive stage or metastatic disease for whom EP would be a standard therapy.


Eligibility Criteria:
Inclusion Criteria:

* Cancer diagnosis and stage (histological or cytological confirmed extensive stage lung cancer, which EP would be considered a standard therapy, required at the time of diagnosis.)
* No prior chemotherapy or immunotherapy for advanced stage lung cancer (prior radiotherapy will be permitted if it is outside of the measurable field and greater than or equal to 2 weeks prior to entry to the study.)
* WHO performance status 0-2

Exclusion Criteria:

* Untreated unstable brain or meningeal metastases
* Patient with inappropriate laboratory tests values
* Inadequate bone marrow reserve.
Efficacy of Usual Vitamin D Supplementation and Its Impact on Children and Adolescents Calciuria.

Vitamin D is not seen anymore only as a phosphocalcic and bone hormone, but also as having an effect on global health (anti-infective, anti-inflammatory, anti-tumour roles and cardiovascular protection).

Until recently, vitamin D repletion was defined as the minimal concentration that enables the prevention of rickets in children and osteomalacia in adults, i.e, approximately 8 ng/mL (20 nmol/L). However, most of the international experts agree to set minimal threshold of 25 OH vitamin D serum concentration, higher than the one previously admitted, with a limit of 20 ng/mL (50 nmol/L) to define a vitamin D deficiency and a limit of 30 ng/mL (75 nmol/L) to define vitamin D insufficiency.

Recommendations for Vit D supplementation in healthy children were updated in France in 2012. The invariable supplementation of infants and toddlers is efficient since deficiency-related rickets have almost disappeared; however there is very few information in ill children populations.

Vit D supplementation tolerance is usually considered as good and over-dosage risks are low, however these studies were conducted more than 30 years ago, and as far as we know, there is no study about calcium urinary excretion kinetics after intake of a 100 000 IU vial of cholecalciferol (Uvedose®). When 25 OH vitamin D serum concentrations exceeds 200 ng/mL, which is very rare in daily practice, toxic effects of Vit D may theoretically be observed, particularly hypercalcemia and hypercalciuria.

Vitamin D deficit is very common in children with chronic kidney disease (CKD) with a 50 to 92% prevalence depending on the studies; it it is a risk factor for secondary hyperparathyroidism.

Although international guidelines regarding the care of CKD children recommend 25 OH vitamin D serum concentrations over 75 nmol/L, there are no practical recommendations in terms of dose and frequency of native Vit D treatment.

Therefore, the objectives of the present study has are the following:

* to validate prospectively the efficacy of our service usual care for Vit D supplementation of children and adolescents seen in the paediatric nephrology department.
* and to study the effect of Vit D supplementation (100 000 IU vial of cholecalciferol) on calciuria in these patients.


Eligibility Criteria:
Inclusion Criteria:

* Age : between \[18 mo et 18 yo\[
* Patients seen in the paediatric nephrology service and having :

  * Chronic kidney disease
  * Renal transplant
  * Stable nephrotic syndrome (i.e., normal protidemia at inclusion)
* Initial 25 OH vitamin D concentration \< 75nmol/l
* Patient agree to participate (if old enough to give his agreement) and written informed consent signed by parents
* Patients affiliated within the French universal healthcare system

Exclusion Criteria:

- Contraindication to 100 000 IU Uvedose® treatment (according to the Summary of Product Characteristics: known hypersensitivity to vitamin D or hypercalcemia, hypercalciuria or nephrolithiasis).
Exercise Target Brain Oscillations in Psychosis

Previous studies have shown that cardiorespiratory fitness (how well the heart and lungs are able to function during physical activity) is often reduced in people with psychosis. The goal of this research study is to test the hypothesis that aerobic exercise can lead to small changes in brain functioning that can influence visual perception and attention in psychosis. The type of aerobic exercise used in this study is called Sprint Interval Training, or "SIT". Information from this study will help to develop interventions that enhance cognition and maximize the quality of life for persons living with psychosis.

The exercise procedure used is called SIT, which involves training rigorously on a stationary bike for a short period of time followed by a resting period.


Eligibility Criteria:
Inclusion Criteria:

* Meet diagnostic criteria for schizophrenia or schizoaffective disorder
* Are age 18-64
* Fluent in written and spoken English
* Have an outpatient status of at least 1 month prior to participation
* Has been on a stable dose of psychiatric medication for at least one month prior to participation (titration to a lower dose of psychotropic medications under supervision of a psychiatrist can be allowed at the discretion of the investigators)

Exclusion Criteria:

* Current or possibility of current pregnancy (self-reported)
* Active suicidal ideation at screening or baseline assessments, or previous intent to act on suicidal ideation with a specific plan, preparatory acts, or an actual suicide attempt within the last 3 months, as indicated by the C-SSRS
* WTAR standardized score below 70
* American College of Sports Medicine contraindication to exercise
Risk Stratification in Patients With Preserved Ejection Fraction

The purpose of the study is to assess the prevalence and the prognostic value of non-invasive indexes and programmed ventricular stimulation for sudden cardiac death in post-myocardial infarction (MI) patients with left ventricular ejection fraction (LVEF)\>40%.

1000 asymptomatic post-MI patients\>40%, at least 40 days post-MI, revascularized or without needing further revascularization (in any case without any evidence of ischemia) will be enrolled.

The patients will be divided into two categories:

1. Asymptomatic patients with revascularized ST-elevation MI (STEMI) (remaining stenoses in non culprit vessels \<70%) at 40 days post-MI (when LVEF\>40% will be re-assessed)
2. Asymptomatic patients late (at any time after 40 days) after MI (initially STEMI-NSTEMI at discharge Q-non Q) with LVEF\>40% right after a negative stress test or right after a negative for stenoses control coronary catheterization All patients will undergo non-invasive evaluation (ECG, Holter monitoring and 45-min high resolution recording). In case they fulfill at least one out of seven pre-specified criteria they will undergo programmed ventricular stimulation and implantable cardioverter-defibrillator (ICD) implantation (if inducible) All patients will be followed-up for 3 years for sudden cardiac death and its surrogate (appropriate ICD activation)

Eligibility Criteria:
Inclusion Criteria:

* Asymptomatic patients with revascularized STEMI (remaining stenoses in non culprit vessels \<70%) at 40 days post-MI (when LVEF\>40% will be re-assessed)
* Asymptomatic patients late after MI (initially STEMI-NSTEMI at discharge Q-non Q) with LVEF\>40% right after a negative stress test or right after a negative for stenoses control coronary catheterization

Exclusion Criteria:

* Episodes of sustained VT or aborted sudden cardiac death (SCD) 48 hours after the acute MI phase.
* Episodes of syncope within the last 6 months
* Cancer, liver failure (cirrhosis), end-stage renal disease
* Use of anti-arrhythmic drugs other than b-blockers
The Use of Acupuncture for Treatment of Chemotherapy-induced Peripheral Neuropathy (CIPN).

This study aims to determine the effectiveness of the use of acupuncture in relieving sensory and motor symptoms as well as functional impairment and quality of life of patients with chemotherapy induced peripheral neuropathy

The trial is a clinical, single-center, randomized trial study that will involve 30 adult cancer patients with chemotherapy-induced peripheral neuropathy randomized into two groups (control and acupuncture treated with 10 sessions, 2X per week). Both CIPN patients groups will be submitted to a complete physical examination and to clinical assessments with National Cancer Institute Common Terminology Criteria for Adverse Events Scale Version 2.0, Functional Independence Measure Scale, European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 Scale and Visual Analogue Scale for pain before treatment and in 5 weeks of follow-up after treatment.

Eligibility Criteria:
Inclusion Criteria:

Cancer adult patients with CIPN -

Exclusion Criteria:

Other neuropathy

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Kisspeptin Administration Subcutaneously to Patients With IHH

The goal of this study is to see whether kisspeptin, a naturally occurring hormone, can stimulate the release of other reproductive hormones in men and women with idiopathic hypogonadotropic hypogonadism (IHH). The investigators are also examining whether kisspeptin can help women release eggs from their ovaries. Kisspeptin will be administered SC for two weeks in a pulsatile fashion. Ultrasound monitoring of ovarian follicular growth (for women) and frequent blood sampling (every 10 minutes for up to 70 minutes) will be performed to assess the physiologic response to kisspeptin over time.

Funding Source: FDA OOPD

Assignment: All study subjects will undergo the same interventions.

Delivery of Interventions:

* Each subject will undergo a review of their medical history, physical exam, and screening laboratories.
* A single SC injection of leuprolide acetate may be administered approximately six days before kisspeptin administration.
* A pelvic ultrasound will be performed on women to assess baseline follicular size.
* A pump will be placed to administer pulsatile SC kisspeptin for two weeks.
* During the course of kisspeptin administration, subjects will

  * Undergo q10 min blood sampling (approximately 10 sessions, 70 minutes each)
  * For women, undergo pelvic ultrasounds (approximately 3 sessions)
* Optional q10 min sampling up to 8 hours may take place before and after the course of kisspeptin

Eligibility Criteria:
Inclusion Criteria:

* Congenital IHH

  o Confirmed diagnosis by medical provider supported by low sex steroids in the setting of low or inappropriately normal gonadotropins
* Normal blood pressure (systolic BP \< 140 mm Hg, diastolic \< 90 mm Hg)
* Not using hormonal replacement or willing to complete an appropriate washout for that particular medication and method of administration
* No current or recent use of a medication that, in the opinion of a study investigator, can modulate the reproductive axis or willing to complete an appropriate washout for that particular medication and method of administration

Exclusion Criteria:

* Any condition (medical, mental, or behavioral) that, in the opinion of a study investigator, would likely interfere with participation in/completion of the protocol
* Excessive alcohol consumption (\>10 drinks/week) and/or active use of illicit drugs

  o Any active use of marijuana will be evaluated by a study medical professional to determine if it may impact study participation.
* Pregnant or trying to become pregnant
* Breast feeding
* History of bilateral oophorectomy (ovaries were removed)
Development and Progression of Carcinoid Heart Disease in a Cohort of Adult Patients With Neuroendocrine Tumors

Carcinoid Heart Disease (CHD) is a rare form of heart disease, occurring in over 50% of the patients with carcinoid syndrome. Pathophysiology, prognostic factors of development of Carcinoid Heart Disease and progression of disease remain unclear.

This observational multicenter cohort study is designed to study the occurrence of Carcinoid Heart Disease in patients with differentiated carcinoid tumors, to describe numerous factors influencing the occurrence, severity, progression and long-term survival of patients with Carcinoid Heart Disease. Basic informations and detailed diagnosis informations (oncological and cardiac parameters), are collected by professional doctors. Clinical outcomes (onset of Carcinoid Heart Disease, cardiac surgery, related death) will be followed up every year or every six/three months if clinically indicated.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years
* Patients followed in a NeuroEndocrine Tumor center with a reference cardiologist
* Patient with:

  * Histologically documented metastatic well-differentiated ileum neuroendocrine tumor or
  * Histologically documented metastatic well-differentiated bronchial neuroendocrine tumor, or
  * Histologically documented well differentiated neuroendocrine tumor, regardless of the primitive site or unknown primitive site and presenting a carcinoid syndrome and / or an elevation of urinary 5HIAA \> 2 fold the upper limit of normal range
* Information given to the patient and his documented non-opposition

Exclusion Criteria:

* Poorly differentiated neuroendocrine carcinoma
* Patient unable / unwilling to follow the cardiac monitoring recommended by good practice data
* Any medical, geographical, sociological, psychological or legal situation that does not allow the patient to complete the study
Ulnar Nerve Deep Branch Compression by a Ganglion

Ulnar nerve compression is common at the elbow, but less common at the wrist. The purposes of this study are to report a series of 9 patients with pure ulnar nerve deep branch compression by a ganglion and to evaluate the outcome following a surgical treatment. According modified Bishop's scoring system, the investigators would evaluate postoperative results of this uncommon nerve lesion.

Pre- and post-operative physical examination include assessment of tenderness and strength (grip and pinch). Grip strength and tip pinch strength between the thumb and index finger are measured using the E-LINK system. According Bishop's scoring system, the investigators redesign a questionnaire for comprehensive assessment of this uncommon nerve lesion.

Eligibility Criteria:
Inclusion Criteria:

Ulnar nerve deep branch compression by a ganglion -

Exclusion Criteria:

Ulnar nerve deep branch compression caused by other reasons

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Risk Factors of Preterm Birth Born in Hospital：a Prospective Multicenter Case-control Study

The purpose of this study is to explore the perinatal risk factors of preterm birth in China.

Preterm birth is a global scourge, and the leading cause of newborn deaths (babies in the first 4 weeks of life) and raised to the leading cause of death among children under 5 years of age, responsible for approximately 1 million deaths in 2015. In China, the prevalence of preterm increased from 4\~5% in 1990s to 7\~10% in 2010. Preterm birth become a burden to both the family and society. Therefore, the risk factors of preterm birth become the critical issue of both Obstetrics and Neonatology. More importantly, few multicenter prospective studies on risk factors of preterm birth included potential reasons such as maternal occupation, psychology condition and lifestyles during pregnancy were conducted in China. Thus, the aim of our study is to explore the perinatal risk factors of preterm birth nowadays in China.

Eligibility Criteria:
Inclusion Criteria:

* Live-born infants \>20weeks of gestational age

Exclusion Criteria:

* Stillbirth