cyrilzakka/clinical-trials huggingface dataset:
The Effect of the Incretin Hormones on the Endocrine Pancreatic Function During Hyperglycemia in End-stage Renal Disease

Patients with end-stage renal disease (ESRD) have a high prevalence of impaired glucose metabolism. The pathophysiological cause is uncertain, but disturbances in the secretion, elimination and effect of glucagon, insulin and the two incretin hormones glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), probably play important roles. Our research group has previously found that dialysis patients without type 2 diabetes mellitus (T2DM) have a reduced incretin effect and an inability to suppress glucagon after a meal - two early pathophysiological characteristics of patients with T2DM and normal kidney function.

The aim of the project is to provide a detailed description of the mechanisms underlying the (patho)physiological effects of the incretin hormones in patients with ESRD. We plan to investigate the above mentioned disturbances during fasting and hyperglycaemic conditions using incretin infusions during glucose clamping. Furthermore, stable isotopic tracers will be used to determine the effect of the incretin hormones on the endogenous glucose handling.

We hypothesise that the effects of the incretin hormones in ESRD will be reduced in respect to healthy control subjects.

The effect of the incretin hormones on the endocrine pancreatic function in a uremic environment will be explored during fasting and hyperglycemic conditions in three randomised examination days.

At a preceding screening day, an oral glucose tolerance test (OGTT) and a dual energy x-ray absorptiometry (DXA) scan will be performed to determine glucose tolerance and the distribution of muscle and adipose tissue. The study will be carried out on three separate days differing with respect to the hormones infused: GLP-1, GIP or placebo (saline) which are double blinded. The patients will meet from an overnight fast and an infusion of one of the hormones is initiated. At the same time labeled glucose will be infused to determine the endogenous hepatic glucose production. A glucose infusion is adjusted according to frequent plasma glucose measurements to maintain fasting glucose level. After 2 hours a steady state of the tracer is achieved and a 2 hour hyperglycemic clamp, 3 mmol/l above fasting glucose concentration will be started. The tracer infusions are continued during the hyperglycemia. After the 4 hour clamp an arginine bolus will be administered to measure the ability to increase the secretion of insulin and glucagon.

Eligibility Criteria:
Inclusion Criteria (End-stage renal disease):

* Chronic hemodialysis-dependent uremia in more than 3 months

Inclusion Criteria (Healthy controls):

* Normal kidney function

Exclusion Criteria:

* Fasting plasma glucose ≥ 6.1 mmol/l
* 2h plasma glucose ≥ 7.8 after ingestion of 75 grams of glucose
* Admittance to a hospital
* Anemia (Hb \< 6.0 mmol/l)
* Ongoing treatment with drugs interfering with glucose metabolism including steroids and calcineurin inhibitors
* Bowel resection or any other large abdominal surgery
Outcomes Study to Assess STatin Residual Risk Reduction With EpaNova in HiGh CV Risk PatienTs With Hypertriglyceridemia

The study is a randomized, double-blind, placebo-controlled (corn oil), parallel group design that will enroll approximately 13,000 patients with hypertriglyceridemia and low HDL and high risk for CVD to be randomized 1:1 to either corn oil + statin or Epanova + statin, once daily, for approximately 3-5 years as determined when the number of MACE outcomes is reached.


Eligibility Criteria:
Inclusion Criteria:

1. Men or women, ≥18 years of age.
2. Patient must be on a stable diet and statin\* therapy at least 4 weeks prior to randomization (Visit 2) and meet the following criteria:

   1. LDL-C \<100 mg/dL
   2. TG level ≥180 and \<500 mg/dL and HDL-C \<42 mg/dL for men or HDL-C \<47 mg/dL for women
3. Patient is at high risk for a future cardiovascular event if at least one of the following criteria (3a, 3b or 3c)\* is present via patient history, physical exam, or medical records at the time of screening:

   1. Any atherosclerotic CVD as defined in protocol.
   2. History of diabetes mellitus (type 1 or 2) and ≥40 years of age for men and ≥50 years of age for women, plus one of the risk factors defined in protocol.
   3. Male patients \>50 years of age or females \>60 years of age, with at least one of the risk factors defined in protocol.

Key Exclusion Criteria:

1. Allergy or intolerance to omega-3 carboxylic acids, omega-3 fatty acids, omega-3-acid ethyl esters, or corn oil. 2.Use of fibrates, bile acid sequestrants, or niacin or its analogues (\>250 mg/day) within 4 weeks prior to Visit 2. 3.Statin naïve at Visit 1.
Isolation and Establishment of Gustatory Cell Lines in Patients Operated on for Cancer of the Mobile Tongue - ImmortTasteCELL

In terms of incidence, cancer of the tongue is one of the leading cancers in France. Moreover, this cancer is associated with physiological complications ranging from swallowing disorders to loss of taste. Following surgery, impaired perception of food taste may lead to cachexia. It is therefore necessary to carry out research in the field of impaired taste, notably with regard to the regeneration of taste buds. However, there is currently no available functional model of taste bud cells.

It is therefore necessary to obtain a cell line of human taste cells. These immortalised human cells will allow us to better orient our investigations for applications in humans: search for and characterisation of "taste modifiers" synthesised using organic chemistry, able to trigger the perception of food in cases of taste loss or taste impairment.

Moreover, given recent studies conducted by the investigating team proposing the existence of a fatty taste and its implication in obesity, the work of the team could be oriented towards the synthesis of lipid-receptor agonists, by analogy with artificial sweeteners instead of sugar. The availability of these chemical molecules would lead to a reduction in lipid intake as these agents contain no (or very few) calories. They will act as an organoleptic decoy.


Eligibility Criteria:
Inclusion Criteria:

* between 18 and 70 years old,
* with cancer of the mobile tongue
* requiring surgery

Exclusion Criteria:

- chronic smokers
Efficacy Safety Study of Arformoterol QD Dosing Versus BID Dosing in COPD

To evaluate the efficacy and safety of arformoterol tartrate inhalation solution 30μg/4mL QD (two 15μg/2mL dosed in combination) over a 24-hour period compared to arformoterol tartrate inhalation solution 15μg/2 mL BID in subjects with COPD.

This is a modified blind, randomized, multicenter, single dose two-way crossover study to assess the efficacy and safety of arformoterol 15μg BID versus arformoterol 30μg QD in subjects with COPD. Subject participation will last approximately three weeks and will include a screening visit, two 24-hour visits, and a follow up telephone call. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects must be at least 45 years old at the time of consent.
* Subjects must have a pre-established primary clinical diagnosis of COPD.
* Subjects must have a baseline FEV1 of ≤ 65% of predicted normal value at Visit 1.
* Subjects must have a FEV1 ≥ 0.70L at Visit 1.
* Subjects must have a FEV1/forced vital capacity (FVC) ratio of ≤ 70% at Visit 1.

Exclusion Criteria:

* Subjects who do not have a 15 pack-year smoking history and a baseline breathlessness severity grade of 2 (as measured by the Modified Medical Research Council \[MMRC\] Dyspnea Scale Score) at Screening.
* Subjects with life-threatening/unstable respiratory status, including upper or lower respiratory tract infection, within the previous 30 days prior to Visit
Integrated Approaches to Food Allergen and Allergy Risk Management

Patients with history of a food allergy to hazelnut, walnut or celeriac will undergo food provocation with a dose of the allergenic food to which 5% of the respective food allergic population (ED05) has been calculated to respond with allergic reactions (single shot study).

In patients with a hazelnut or peanut allergy a double-blind placebo controlled food challenge with cookies containing either placebo or hazelnut and peanut respectively will be performed to determine threshold levels eliciting an allergic reaction. The results for threshold levels determined by cookie matrix will be compared to the results gained from the EuroPrevall project (matrix comparison study).

In patients with a walnut allergy double-blind placebo controlled provocation with walnut will be combined with the intake of proton pump inhibitor (PPI) or with placebo to assess the impact of PPI on the threshold level and on the clinical manifestation.

single shot study, matrix comparison and walnut/PPI study

1. detailed case history, blood sampling and prick testing with different foods will performed.
2. food provocation with a chocolate dessert meal containing either hazelnut, walnut or celeriac (ED05) will be performed (single shot study) in patients with a positive case history of an allergic reaction to either hazelnut, walnut or celeriac or with two meals containing either placebo or hazelnut and peanut respectively in hazelnut and peanut allergic patients or with three meals containing either placebo or walnut in walnut allergic patients.
3. in patients with a negative single shot challenge an open provocation with native hazelnut, walnut, celeriac will be performed unless the patients do not have had a positive previous food provocation with the respective food. In patients with a negative double-blind placebo-controlled food challenge an open provocation with hazelnut or peanut or walnut will be performed to confirm tolerance.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* For single shot study: history of a hazelnut, walnut, celeriac allergy due to an unequivocal accidental exposure with typical acute allergic reaction within the preceding 2 years and positive allergen-specific skin prick test/specific Immunoglobulin E or recent positive oral food challenge with hazel, walnut or celeriac within previous 2 years in children \<16 years, but no time limit specified for adults
* For matrix comparison study: history of peanut or hazelnut allergy
* For walnut/PPI study: history of walnut allergy. The minimum age for this study is 18 years

Exclusion Criteria:

* Severe disease (heart, liver, kidney), acute febrile infection
* Intake of Ketotifen (past 2 weeks), corticosteroids (past 2 weeks), histamine-1-receptor blocker (past 3 days apart first generation past 7 days)
* Anaphylactic reaction (past 4 weeks)
* Uncontrolled bronchial asthma, forced expiratory volume \< 70% predicted
* Pregnancy
* Acute infection or allergy
* Uncontrolled atopic dermatitis
* Chronic urticaria
* Mastocytosis
* Uncontrolled hypertension
Effect of Samsca on Control of Hyponatremia and Extracellular Fluid in Cirrhotic Patients With Ascites

This study is to evaluate the efficacy of a 2-week course of tolvaptan in improving serum sodium and the excretion of extracellular fluid in liver cirrhotic patients with ascites and hyponatremia


Eligibility Criteria:
Inclusion Criteria:

1. Subjects aged ≥ 20 years
2. Subjects who have been diagnosed with hyponatremia \[serum sodium \< 125 mEq/L or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction\]
3. Subjects who have been diagnosed with an ascites on the abdominal ultrasound.
4. Subjects who have diagnosed with cirrhosis.
5. Subject or their legally acceptable representatives are able to provide informed consent/assent.

Exclusion Criteria:

1. Subject who has ascites by other causes (Tbc, CHF, malignancy, or renal disease) acute severe hyponatemia : Serum Na level \< 120 mmol/L and Doubt of symptom caused by hyponatremia and the case which should raise serum Na level urgently based on the investigator's judgment international normalized ratio (INR) \>3.0 serum sodium ≥135 mmol/L serum potassium \> 5.5 mmol/L Creatinine ≥ 2.0 mg/dL Hepatorenal syndrome defined as 'New International Ascites Club's diagnostic criteria' systolic arterial pressure of \< 80 mmHg recent myocardial infarction (\< 6 month) spontaneous bacterial peritonitis gastrointestinal bleed ( ≤7 days from randomization) ongoing hepatic encephalopathy of \> grade1 known hepatocellular carcinoma intractable ascites
2. Subject who requiring urgent intervention to raise serum sodium acutely
3. Subject who are unable to sense or to respond appropriately to thirst
4. Subject with hypovolemic hyponatremia
5. Subject who should take strong CYP3A inhibitors (clarithromycin, ketoconazole, itraconazole, ritonavir, indinavir, nelfinavir, saquinavir, nefazodone, and telithromycin)
6. Subject who are anuric as no benefit is expected
7. Subject who has genetic defects such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
8. Subject who has fluid depletion
9. Female subjects who are pregnant or lactating
10. Subject judged by the investigator to be inappropriate for inclusion in the trial for any other reason
Autonomic Failure Patients for RNA Blood Sampling

The purpose of this study is to identify 15 patients with autonomic failure and obtain blood samples for RNA from those participants and 15 control subjects within the same age range. The stabilized blood samples, along with a limited data set, will be shipped to Western Michigan University where the actual laboratory analysis (a separate study) of the samples will take place.

Unique genetic inscriptions, called gene expression signatures, are currently being identified for many diseases, including neurological diseases. The secondary goal of this study is to support the research being done at WMU and they try to look for MSA-specific signs are present in whole blood samples of MSA patients at late-stages of the disease. This is a pilot study that has a long term goal (through additional studies) a MSA-specific gene expression signature for the development of a diagnostic test for this disease that can be used in the future. Other patient groups with autonomic failure, characterized by significant drop in blood pressure on standing, will also be included in this study, to look for similar genetic inscriptions.

This pilot study is expected to last for 2 years. The investigators at WMU will need some de-identified health Information about the subjects, including their age at diagnosis, age (when sample drawn) and list of their medications

Patients with one of the following autonomic problems will be recruited to participate in this study: multiple systems atrophy (MSA), pure autonomic failure (PAF) or Parkinson's Plus. The study consists of drawing 15 ml of whole blood for RNA. The blood is drawn in special collection tubes to stabilize the RNA material in the blood. The samples will be frozen and shipped to WMU for analysis.

The patients will also be asked to provide the current list of their medications, their age and the age when they were first diagnosed with their neurologic or autonomic disorder. This information will be de-identified and sent to the investigators at WMU as a limited data set.

Eligibility Criteria:
Inclusion Criteria for patients:

* presumed or probably diagnosis of autonomic disorder characterized by orthostatic hypotension
* age between 50 - 75 years
* Male or female
* Able and willing to provide consent

Inclusion Criteria for controls:

* Absence of neurological disorder
* age between 50 - 75 years
* Male or female
* Able and willing to provide consent

Exclusion Criteria:

* inability to provide consent
The Safety and Efficacy of TWP-101 in Patients With Advanced Solid Tumor

This is a multi-center, phase Ia/Ib, open clinical study to evaluate the safety and efficacy of TWP-101 in patients with advanced solid tumor. This study consists of two parts (Part A and Part B). Part A was a dose escalation study, and Part B was a dose expansion study.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically or cytologically confirmed advanced solid tumor that failed, couldn't tolerate or refused standard treatments;
* ECOG score 0 or 1;
* At least 1 measurable lesion according to RECIST 1.1

Exclusion Criteria:

* Known hypersensitivity to any ingredient of TWP-101;
* Receiving any anti-cancer drugs within 4 weeks;
* History of serious systemic diseases;
* History of serious autoimmune diseases;
* Pregnancy or lactating women.
Practice of Acceptance, Awareness, and Compassion in Caregiving (PAACC)

The Primary objective of the study is to evaluate the effectiveness of mindfulness based caregiver intervention, Practice of Acceptance, Awareness, and Compassion in Caregiving (PAACC) compared to an established cognitive behavior therapy based dementia caregiver intervention, Resources for Enhancing Alzheimer's Caregiver Health (REACH) in improving caregiver burden and quality of life of care recipient.

The study is a randomized controlled trial comparing a mindfulness-enhanced evidence-based caregiver skill-building intervention (PAACC) to REACH-VA to reduce caregiver burden and increase quality of life of the care recipient. For this, caregivers of persons with ADRD or TBI-AD who have moderate to severe burden will be randomly assigned to either receive PAACC or receive REACH-VA. Both the interventions will include 4 biweekly sessions delivered by trained interventionists, followed by an outcome testing session after the intervention. Outcomes of caregiver stress, health and well being will be assessed at baseline and at the end of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Caregivers will include family members living with the individual diagnosed with Alzheimer's Disease( AD) or Alzheimer's disease related dementia(ADRD) or Traumatic Brain Injury -AD(TBI-AD) with moderate to severe caregiver burden .
* Care recipients with diagnosis of Diagnosis of AD or ADRD or TBI-related AD .

Exclusion Criteria:

* Care givers: Determined to be an imminent risk to self or others,the Care recipient currently resides in a nursing home or assisted living facilities, unable to provide their own consent to participate in the study , and active substance use disorder in the last 1yr.
* Care recipient: Determined to be an imminent risk to self or others, Caregiver is not interested in the study, unable to obtain informed consent from the Care recipient
The Dose Response of Prednisone on Biochemical and Clinical Makers in Adult Healthy Volunteers

The purpose of this study is to further access the utility of biochemical and clinical biomarkers for glucocorticoid-mediated anti-inflammatory effects and safety endpoints against which dissociated agonists of the glucocorticoid receptor (DAGR) will be evaluated in adult healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or females willing to be confined and comply with scheduled visits
* Women are to be surgically sterile.

Exclusion Criteria:

* History of febrile illness within 5 days prior to the first dose
* Positive urine drug screen
* Treatment with an investigational product within 30 days prior to the first dose of study medication
Research on Patients With Heart Transplantation

This trial was a single-center, prospective cohort study.The purpose of this clinical research is to evaluate the accuracy of combining multimodality MR Imaging with circulating exosomal miRNA expression to diagnose acute rejection in patients with heart transplantation，thus it may be helpful for timely intervention to improve the patient's prognosis.

Acute rejection (AR) after heart transplantation remains the major factor limiting long-term survival, and an independent risk factor for chronic allograft vasculopathy. Currently, there remains no reliable non-invasive method to detect AR. Multimodality magnetic resonance (MR) imaging shows accurate detection of myocardial damage, such as interstitial cell infiltrates, edema, hemorrhage, myocyte damage/necrosis and capillary stenosis or fragmentation. It turned out that the indicators in both MR imaging and circulating exosomal miRNA showed difference between patients with and without AR in our initial research work. Therefore, we hypothesize that circulating exosomal miRNA may play an important role in the activation of signaling pathway in AR after heart transplantation, which can be detected by multimodality MR imaging. All transplant recipients receiving transplantation follow-up care in our center were approached. In the present research we aim to combine multimodality MR imaging with circulating exosomal miRNA to explore a new evaluation methodology and platform for early and noninvasive detection of AR after heart transplantation. We attempt to confirm contribution of circulating exosomal miRNA to myocardial damage of AR through biopsy-proven allograft rejection and animal heterotopic heart transplantation.

Eligibility Criteria:
Inclusion Criteria:

1. All patients after orthotopic heart transplantation.
2. All patients has signed informed consent.

Exclusion Criteria:

1. Patients with early graft failure within 24-48h after transplantation requiring clinical support or intensive care treatment.
2. Patients with severe renal failure.
3. Patients with any general contraindication to MRI.