cyrilzakka/clinical-trials huggingface dataset:
Copeptin as a Biomarker for Central Diabetes Insipidus Development Following Pituitary Surgery

1. Access the optimal cut point value of copeptin which predicts development of central diabetes insipidus postoperatively with highest accuracy.
2. Access the optimal cut point value of copeptin which predicts the lack of central diabetes insipidus postoperatively with highest accuracy
3. Access the relative change in copeptin values between baseline and post-surgery as a predictor for diabetes insipidus development.

Patient serum levels of copeptin would be measured after phlebotomy of 3 ml of blood in EDTA tube twice a) within 1-4 hours of extubation and b) within 4-24 hours of extubation (the morning following surgery).

Eligibility Criteria:
Inclusion Criteria:

\* Patients with sellar and suprasellar masses who undergo neurosurgical procedure at Mayo Clinic Rochester.

Exclusion Criteria:

\* Patients with preexisting CDI.
Comparison of Visceral Adipokines Visfatin, Vaspin and Omentin Levels in Gestational Diabetes Mellitus Pregnant Women

The prevalence of maternal obesity is increasing rapidly worldwide and constitutes an important obstetric problem that increases mortality and morbidity in both mothers and infants. Obese women are prone to pregnancy complications such as gestational diabetes mellitus (GDM), and children of obese mothers are more likely to develop cardiovascular and metabolic disease later in life. The risk of developing GDM in obese pregnants is 1.3-3.8 times higher than in pregnant women with a normal body mass index, and approximately 70% of women with GDM remain at risk of developing type 2 diabetes until 28 years postpartum. Gestational diabetes mellitus (GDM) affects approximately 6% of pregnant women and its prevalence is increasing in parallel with the obesity epidemic. GDM is associated with an increased risk of adverse pregnancy outcomes, including macrosomia, preterm delivery, neonatal hypoglycemia, neonatal jaundice, and congenital anomalies. It is also associated with a higher incidence of type 2 diabetes mellitus after birth. It is known that visceral adipose tissue increases in obese women. It is thought that there is a relationship between visceral adipose tissue increase and diabetes. In this study, the levels of new adipocytokines such as Visfatin, Vaspin and Omentin secreted from visceral adipose tissue in patients diagnosed with GDM will be measured.

The investigators aim in this study the levels of Visfatin, Vaspin and Omentin secreted from this tissue in pregnant women diagnosed with GDM by oral glucose tolerance test (OGTT) between 24-28 weeks of gestation and to determine if there is a relationship between these parameters. For this purpose, , and 87 pregnant women with gestational diabetes diagnosed at 24-28 weeks from the same patient group will be included in the study. . The same number of non-GDM control group pregnant women will also be included in the study at 24-28 weeks. Age, gestational week, pregnancy history (gravida, parity, abortion, missed, ectopic), medical history, preconceptional BMI, current BMI, triglyceride, VLDL, HDL, LDL, cholesterol, HOMA-IR, C-peptide, insulin, Hba1c levels will be saved. In the 2nd trimester, between 24-26 weeks, OGTT will be performed on the patients and the results will be recorded. Visfatin, Vaspin and Omentin levels will be checked and recorded in patients diagnosed with GDM.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years of age
* At the 2.st trimester of pregnancy

Exclusion Criteria:

* History of with diabetes mellitus
* Morbidly obese pregnants
* History of abdomen liposuction
Radioimmunoimaging of Light Chain (AL) Amyloidosis

The purpose of the study is to determine the capability of a radiolabeled amyloid-reactive monoclonal antibody (mAb) to document the presence and distribution of amyloid deposits by PET/CT imaging in patients with AL amyloidosis.

To be eligible for this study, patients must have a confirmed diagnosis of AL amyloidosis without significant cardiac (New York Heart Association class IV) disease and not be on kidney dialysis. Additionally, after testing, their blood must not contain antibodies to mouse proteins. The study requires an intravenous infusion, given over 10 minutes, of the radiolabeled antibody, followed 48 hours later by a PET/CT scan. A repeat scan is done 5 days after infusion of the antibody. A 5-ml blood specimen needs to be furnished 4 and 8 weeks after the antibody infusion.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a confirmed diagnosis of AL amyloidosis.

Exclusion Criteria:

* New York Heart Association class IV
* On renal dialysis
* Serum antibodies to mouse protein
Alternative Protein Short Chronic Study

The world's population needs adequate food supply to sustain food security. The availability of sufficient dietary protein is undeniably a source of concern for human health. This study aimed to assess the satiety and potential health benefits of two types of vegetarian diets when the meat was replaced with buckwheat and respectively fava bean for one-week in the diet of healthy volunteers.

The World Health Organisation (WHO) recommends increasing the intake of fruits and vegetables, legumes, whole grains and nuts to prevent obesity. In Western countries, there is a greater understanding of the health benefits of pulse grains. Consumption of whole grain cereals and grain pulses has been shown to protect against a variety of inflammation-related chronic diseases. Grain cereals, pulses and pseudo cereals are also good dietary protein sources. This study aimed to assess the suitability of buckwheat and fava bean to replace meat for one week in terms of delivering adequate nutrient intake, satisfying hunger and delivering potential health benefits. The composition of human microbial metabolites and the bacterial composition after consumption of the intervention diets by healthy volunteers for one week were also assessed. This study offers data to support the potential of plants as alternative sources of dietary nutrients.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males and females,
* Non-vegetarian,
* non-smokers,
* age 18-65
* with BMI 18-35 kg/m.

Exclusion criteria:

* vegetarian,
* smoker,
* having known allergies,
* using prescription drugs.
* diabetes,
* gastrointestinal disorders,
* kidney disease,
* hepatic disease,
* favism,
* alcohol or
* substance abuse
Evaluating the Safety and Efficacy of SB Injection in Patients With Advanced or Metastatic Colorectal Cancer

The purpose of this study is to determine efficacy of SB injection in Colorectal Cancer.

All eligible patients will receive SB injection therapy for 6 cycles (14\~21 days for each cycle). Efficacy will be evaluated every 3 cycles.

Eligibility Criteria:
Inclusion Criteria:

* Age of 18years or over
* Patients who had failed more than 1 cycle of standard therapy with advanced or metastatic stage and with measurable lesions
* Life expectancy \>/= 5 months
* Not available to any of resectable surgery or radiotherapy
* Patients with adequate organ(e.g. heart, kidney, liver)and bone marrow function, as defined by

  1. Absolute neutrophil count \>/= 1.0 x 10\^9/L, Platelet count \>/= 75 x 10\^9/L
  2. Total bilirubin \< 2.0 mg/dL
  3. Aspartate Aminotransferase and/or Aspartate Aminotransferase \< 5 x Upper Limit Normal
  4. creatinine \< 2 x Upper Limit Normal
* ECOG status 0 to 2
* Female volunteers admitted to the study must be using a reliable means of contraception and must have a negative blood or urine pregnancy test at least 7days ago
* Patients or their legal representatives who have signed the informed consent form.

Exclusion Criteria:

* Have inflammatory bowel diseases
* Have severe diarrhea or ileus
* Previous total colectomy
* Have ileostomy
* Known brain or spinal cord metastases
* Patients who have received chemotherapy within the previous 4 weeks
* Patients who have received radiotherapy related tp colorectal cancer within 4weeks
* Patients who have participated in other clinical study within the previous 4weeks
* Pregnancy or lactation period
* Human Immunodeficiency Virus antibody (+)
* Have active infection or serious concomitant systemic disorder incompatible with the study
* Clinically hypertension or diabetes mellitus not well controlled with medication
* Clinically significant cardiac disease(congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias) or myocardial infarction
* Presence or history of malignancy other than colorectal cancer within 5years
* Have severe Neurologic or psychological disorder
* Patients who have history of allergy with this investigational drug(SB injection)
* Obvious cognitive or physical impairment that would prevent participation
Non-surgical Periodontal Treatment on Hemogram, Lipid and Glycemic Profiles in Patients With Coronariopathies

Objective: The aim of this study was to examine the effects of non-surgical periodontal treatment on the hemogram, glycemic and lipid profiles in cardiopathic patients with an indication for surgical revascularization.

Materials and Methods: Twenty-two patients with chronic periodontitis, over 35 years of age (mean age 59.45 years) randomly assigned into 2 groups were evaluated. Test group (n=11), received periodontal treatment before the surgical procedure, and control group (n=11), did not received periodontal treatment prior to surgery.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing cardiovascular treatment;
* Eight viable teeth in the oral cavity;
* Four periodontal sites with periodontal probing depths ≥5mm in different teeth.

Exclusion Criteria:

-
Glucose Control During Labour in Gestational Diabetes Mellitus With Insulin Treatment: A Randomized Controlled Trial

Pregnant women with gestational diabetes who are treated with insulin and their daily insulin dose is 30 IU or more will be randomized into two groups. Active treatment group will receive insulin-glucose-infusion during labour. In the observational group, blood glucose level during labour will be monitored and insulin-glucose-infusion is started only if needed. The hypothesis is that there will not be a difference in rate of hypoglycemia between the two groups and that the proportion of observational group participants that need infusion is low.

Intrapartum blood glucose level has negative correlation to neonatal blood glucose level in type 1 diabetics. In gestational diabetes the correlation is less clear. In the view of current knowledge, it seems that moderately elevated intrapartum blood glucose may not cause neonatal hypoglycemia. There is no consensus of how to treat intrapartum blood glucose level in gestational diabetics. Some studies have implied that most of mothers with gestational diabetes would have normal blood glucose level during labour and hence would not need any intervention if their daily insulin dosage is less than 0,5-1 IU/kg.

Study participants are recruited into the study at Tampere University Hospital Maternity Ward when their daily insulin dose exceeds 30 IU. Randomization is done at 37th gestational week, if vaginal delivery is planned, and HbA1c is measured. Randomization envelope is opened at the delivery ward when active labour begins and treatment of blood glucose level is carried out accordingly. If insulin dose is 1 IU/kg or more, the participant is treated as in active treatment group despite of result of randomization. All neonates will receive milk substitute after birth in labour ward. Plasma glucose is measured immediately if neonate has symptoms of low blood sugar. If not, plasma glucose is measured approximately two hours after birth and after that every 4 hours until plasma glucose is 3,0 mmol/l or more in three consecutive measurements.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women with gestational diabetes mellitus and daily insulin dosage of 30 IU or more

Exclusion Criteria:

* planned caesarean section,
* premature birth (\< 37 gestational weeks)
Multi-center Trial of ValveClamp

The ValveClamp (Hanyu Medical Technology, Shanghai, China) is the first edge-to-edge mitral valve repair system for interventional operation in China, which is composed of the front clamp, the rear clamp and the closed ring. The purpose of the multi-center trial is to evaluate the safety and efficacy of the ValveClamp for degenerative mirtal regurgistation.

The transcatheter edge-to-edge mitral valve repair device MitraClip (Abbott Vascular, Santa Clara, CA, USA) is the most mature device for mitral regurgitation. Another transcatheter edge-to-edge mitral valve repair device, the PASCAL system, has been shown to be feasible to reduce MR severity. Both the MitraClip and PASCAL devices need a complex steerable deliver system and thus complex process to steer the device to mitral valve. An easy-to-operate transcatheter edge-to-edge mitral valve repair system (ValveClamp) with larger coaptation width was thus recently developed in China. The ValveClamp (Hanyu Medical Technology, Shanghai, China) is the first edge-to-edge mitral valve repair system for interventional operation in China, which is composed of the front clamp, the rear clamp and the closed ring. The purpose of the multi-center trial is to evaluate the safety and efficacy of the ValveClamp for degenerative mirtal regurgistation.

Eligibility Criteria:
Inclusion Criteria:

1. age older than 60 years;
2. moderate to severe or severe mitral regurgitation;
3. symptoms (New York Heart Association \[NYHA\] cardiac function class ≥2) related to MR;
4. the primary regurgitant jet originated from malcoaptation of the A2 and P2 scallops of the mitral valve;
5. high risk for surgery according the MVARC criteria;
6. providing signed informed consent.

Exclusion Criteria:

1. acute myocardial infarction in the prior 4 weeks of the intended treatment;
2. any interventional or surgical cardiac procedure performed within 30 days prior;
3. the need for any other cardiac surgery;
4. echocardiographic evidence of intracardiac mass, thrombus, or vegetation;
5. life expectancy within 12 months;
6. moderate or severe aortic stenosis or regurgitation;
7. mitral valve orifice area \<3.5 cm2;
8. untreated significant coronary stenosis;
9. history of mitral valvuloplasty;
10. Infective endocarditis and rheumatic heart disease;
11. untreated cardiogenic shock, acute pulmonary congestion;
12. unfavored mitral valve anatomy that may preclude device implantation including: calcification or significant cleft in area of the A2 and/or P2 scallops, significant regurgitation beyond A2 or P2 scallops and short posterior leaflet (\<10mm).
13. Other clinical trials that the subjects participated in have not reached the end point.
Family Model DSME in FBOs in the RMI

Health disparities in the Republic of the Marshall Islands are striking, with extremely high rates of type 2 diabetes. Documented prevalence of type 2 diabetes in the Marshall Islands ranges from 20%-50%.This is significantly higher than the global (8.5%) and United States (11%) prevalence. Diabetes doubles the risk of heart disease; is the leading cause of kidney failure, lower limb amputation, and acquired blindness; and reduces life expectancy by as much as 15 years. Diabetes self-management education and support is critical for persons with diabetes. This study aims to conduct a cluster-randomized controlled trial using a wait-list control to evaluate the effectiveness of family model diabetes self-management education and support when delivered in faith-based organizations (i.e., churches) in Marshallese by trained community health workers. The study will be conducted with up to 288 participants with type 2 diabetes and up to 288 of their family members. The primary study outcome will be glycemic control as measured by HbA1c. Secondary biometric measures include: fasting glucose, weight, body mass index, and blood pressure. Survey data will be collected pre-intervention, immediately post-intervention, four months post-intervention, and 12 months post-intervention for the intervention arm of the study. The control arm of the study will have two pre-intervention data collections before beginning the intervention. Data will then be collected from the control group immediately post-intervention, four months post-intervention, and 12 months post intervention.


Eligibility Criteria:
Inclusion Criteria:

* self-reported Marshallese
* 18 years of age or older
* have type 2 diabetes (defined as having HbA1c equal to or greater than 6.5%)
* have at least one family member willing to take part in the study

Exclusion Criteria:

* has received diabetes self-management education in the past five years
* has a condition that makes it unlikely that the participant will be able to follow the protocol, such as terminal illness, non-ambulatory, severe mental illness, severely impaired vision or hearing, eating disorder
* plans to move out of the geographic region
Randomized Bioimpedance vs Clinical Methods in Guiding Ultrafiltration in Hemodialysis Patients

The investigators developed a prospective, randomized, controlled trial to compare strict volume control using bioimpedance (using the BCM - Body Composition Monitor device) versus traditional clinical volume control in hemodialysis patients and the impact on mortality, hydration status, blood pressure values and arterial stiffness.

The investigators developed a randomized controlled study to compare exclusively bioimpedance guided ultrafiltration in hemodialysis patients versus traditional methods for volume assessment.

The duration of the study was 3,5 years.

During the first 2,5 years of the study all enrolled patients were randomized using a block randomization algorithm in two arms.

In the interventional arm the post-dialysis dry weight was prescribed exclusively using the BCM device (Body Composition Monitor - Fresenius Medical Care, Germany).

In the control arm dry weight assessment was done by traditional clinical methods.

In both arms,during the intervention period (2,5 years) BCM measurements were performed every 3 months before dialysis, but only in the interventional arm the values were disclosed to the medical personnel and used to guide the dry weight and ultrafiltration volumes.

In the control arm (clinical), both patients and caregivers were fully blinded from the BCM results.

The BCM device measures for each patient an ideal dry weight interval ( +/- 1.1 kg). In the interventional arm, the prescribed dry weights of the patients were strictly maintained in the ideal weight interval (+/- 1.1 kg) proposed by the BCM device.

Primary outcome was all cause-mortality compared in the strict bioimpedance arm versus the clinical (control) arm and was assessed at 2,5 years.

Secondary end-points, assessed during the randomization period (2,5 years), were to compare blood pressure (determined pre dialysis), arterial stiffness and relative fluid overload (RFO = overhydration/ total body water), as measured by the BCM device.

During the last year of the study, all patients were left free of any intervention, and only arterial stiffness was assessed a third time at 3,5 years.

Eligibility Criteria:
Inclusion Criteria:

* older than 18-year
* on chronic hemodialysis for more than 3 months

Exclusion Criteria:

- life expectancy of less than 1 year

Presence of a condition that may interfere with the determination of dry weight using the Body Composition Monitor (R):

* severe ascites (decompensated liver failure)
* limb amputations
* cardiac stent, pacemaker or defibrillator
* hip prosthetic
* pregnancy
* mental deficiency (impossibility to give consent)
Prospective Validation of an EHR-based Pancreatic Cancer Risk Model

The goal of this prospective observational cohort study is to validate a previously developed pancreatic cancer risk prediction algorith (the PRISM model) using electronic health records from the general population. The main questions it aims to answer are:

* Will a pancreatic cancer risk model, developed on routine EHR data, reliably and accurately predict pancreatic cancer in real-time?
* What is the average time from model deployment and risk prediction, to the date of pancreatic cancer development and what is the stage of pancreatic cancer at diagnosis? The risk model will be deployed on data from individuals eligible for the study. Each individual will be assigned a risk score and tracked over time to assess the model's discriminatory performance and calibration.

To prospectively validate, implement in real-time, and assess performance of an EHR- based PDAC risk-prediction model. To test the hypothesis that our model will reliably predict PDAC in a real-time clinical setting, we will conduct a multi-center prospective cohort study, deploying the PDAC risk model within the TriNetX federated network database, and will take the following steps:

i) generate a risk prediction score for each individual under the care of 44 health care organizations (HCOs) in the USA ii) follow all individuals for up to 3 years to assess the primary end-point of PDAC development.

The following metrics will be used to test the discriminative performance and calibration of the EHR-based PDAC risk model in predicting incident PDAC, at the end of the 3-year period:

1. AUROC, sensitivity, specificity, PPV/NPV for assessing discrimination
2. Calibration: for assessing the accuracy of estimates, based on the estimated to observed number of events

Eligibility Criteria:
Inclusion Criteria:

* Male and females age \>= 40 years from 44 US HCOs from the TriNetX platform
* at least 2 clinical encounters to the HCO, within the last year, before the study start date

Exclusion Criteria:

* Personal history of PDAC or current PDAC
* Age below 40

Notes on sampling method: no sampling was performed. All eligible individuals are included in this study.