cyrilzakka/clinical-trials huggingface dataset:
Effect of Apelin on Insulin Sensitivity in Type 2 Diabetic Volunteers

Preclinical studies have demonstrated in mouse models that (PYR1)-apelin-13 exerts a glucose-regulating action in vivo. The (PYR1)-apelin-13 effect on insulin sensitivity in healthy overweighed volunteers has been previously assessed in a phase I clinical trial (APELINS study; NCT02033473). The APELINS-2 clinical trial aims to expand the initial proof of concept to the population targeted by future innovative insulin-sensitizing therapies: patients living with type 2 diabetes.

Insulin sensitivity is measured using the hyperinsulinemic euglycemic glucose clamp method. The hypothesis of the investigators is that a continuous (pyr1)-apelin-13 infusion improves insulin sensitivity of type 2 diabetic patients compared to placebo infusion.

This study could bring new elements for understanding the pathophysiology of insulin resistance and type 2 diabetes mellitus in humans and could lead to the development of innovative therapies in type 2 diabetes mellitus.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of type2 diabetes
* Body Mass Index between 27 and 33 kg / cm ²
* HbA1c \< 8.5%
* Non-pathological Electrocardiogram
* Heart rate between 50 and 80 beats per minute at rest.
* Complete Blood Count (CBC) with no significant anomaly in terms of the investigator..
* Serum electrolytes without clinically significant abnormalities in terms of the investigator.
* Liver function tests without clinically significant abnormalities in terms of the investigator
* Renal function tests without clinically significant abnormalities in terms of the investigator
* Good peripheral vein (forearm and back of the hand).
* Agreement to participate in the establishment of a serum bank.
* Ability to sign informed consent.
* Affiliation to a social security scheme

Exclusion Criteria:

* Secondary prevention of cardio-vascular disease
* Insulin therapy or Glucagon Like Peptid 1 (GLP-1) analogs therapy in the 6 months before inclusion.
* Risk factor, treatment or electrocardiogram as recommended by International Conference on Harmonization (ICH) E14 "Clinical Evaluation of QT / QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs"
* Repeated a QTc interval\> 450 ms measurement
* Risk factor for torsade de pointes: myocardial infarction, hypokalemia, family history of long QT syndrome
* Personal history of cancer.
* Positive HIV serology.
* Hepatitis B serology positive.
* Positive hepatitis C serology.
* Cognitive impairment or mental illness (at the discretion of the investigator).
* Chronic excessive alcohol consumption (consumption \> 30g/day or 210g/week).
* Person under judicial protection, guardianship.
* Subject with a resting systolic blood pressure greater than 140 mm Hg and diastolic blood pressure greater than 90 mmHg
* Smoking more than 10 cigaret per day and can not be interrupted for 24 hours.
Correlation Between TILs and Blood Cell Counts in Triple Negative Breast Cancer Patients

The PERCEPTION study aims to assess the correlation between blood cell counts (Leucocytes, Neutrophils, Lymphocytes, Platelets, NLR (Neutrophil-to-Lymphocyte Ratio) and PLR (Platelet-to-Lymphocyte Ratio)) and Tumor Infiltrating Lymphocytes (TILs), at baseline and after surgery, for patients diagnosed with triple negative breast cancer. It also aims to assess these circulating elements and circulating tumor DNA as predictive factor of metastatic recurrence in triple negative breast cancer.

Triple negative breast cancer (TNBC) is the most aggressive type of breast cancer. Because of the limited therapeutical strategies, early TNBC relapses are quite common during the five years following treatment.

It has been shown that the presence of tumor infiltrating lymphocytes (TILs) at baseline is related to good pathological response to neoadjuvant chemotherapy. In addition, the presence of a high quantity of TILs in the residual tumor after neoadjuvant chemotherapy is related to better survival rates.

Blood circulating elements, such as peripheral blood cells or circulating tumor DNA, could be of interest in predicting response to treatment and in the prediction of metastatic recurrences in different types of cancer, including breast cancer.

However, the correlation of these markers in triple negative breast cancer has not yet been thoroughly studied.

The PERCEPTION study aims to assess the correlation between blood cell counts (Leucocytes, Neutrophils, Lymphocytes, Platelets, NLR (Neutrophil-to-Lymphocyte Ratio) and PLR (Platelet-to-Lymphocyte Ratio)) and Tumor Infiltrating Lymphocytes (TILs), at baseline and after surgery, for patients diagnosed with triple negative breast cancer. It also aims to assess these circulating elements and circulating tumor DNA as predictive factor of metastatic recurrence in triple negative breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Age \> 18 years
* Diagnosed with primitive, non-metastatic, histologically proved, triple negative breast cancer
* Patient treated with chemotherapy, surgery and radiation therapy
* Patient able to understand the French language
* Patient affiliated to social security
* Obtaining signed written consent

Exclusion Criteria:

* Male
* Unavailable tumoral samples before inclusion
* Unavailable blood test results at baseline, before inclusion
Daptomycin in the Treatment of Subjects With Infective Endocarditis or Bacteremia Due to S. Aureus

The purpose of this study is to compare the safety and efficacy of daptomycin, an antibiotic, to standard therapy in subjects who have infective endocarditis or bacteremia due to Staphylococcus aureus (S. aureus).

Even with prompt treatment, Staphylococcus aureus Infective Endocarditis (IE) continues to be associated with significant morbidity and mortality indicating a need for new therapeutic approaches. In vitro, daptomycin is rapidly bactericidal, with concentration-dependent killing, and MIC90 of 0.5 microgram/ml for S. aureus; in clinical studies, daptomycin appears to be well tolerated and can be administered once every 24 hours by i.v. infusion. These characteristics suggest it should be clinically and microbiologically effective in the treatment of serious S. aureus infections, including IE and bacteremia

Comparison: standard of care (Vancomycin or Semi-synthetic Penicillin with adjunct gentamicin)

Eligibility Criteria:
Inclusion Criteria:

* Documented S. aureus bacteremia within 2 calendar days of the first dose of study medication

Exclusion Criteria:

* Subjects with a creatinine clearance of less than 30 ml/min
* Subjects with pneumonia
* Pregnant, nursing, or lactating
* Documented history of allergy or intolerance to penicillin or vancomycin
* Subjects with osteomyelitis
An Efficacy and Safety Study of Long-Term Risperidone Microspheres in Participants With Schizophrenia

The purpose of this study is to evaluate the long-term efficacy and safety of a long-acting injectable formulation of risperidone (an antipsychotic medication) and its influence on quality of life, in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).

This is an open-label (all people know the identity of the intervention) single-arm, and prospective study (study following participants forward in time) of risperidone microspheres in participants with schizophrenia. Participants will be treated with intramuscular (into a muscle) injections of either 25 milligram (mg) or 37.5 mg or 50 mg of risperidone twice weekly, every 2 weeks for 2 years. The total duration of study will be 2 years. The efficacy of participants will primarily be evaluated by total Positive and Negative Syndrome Scale (PANSS) score. Participants' quality of life and safety will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Participants diagnosed with schizophrenia or schizoaffective disorder (in-patients or out-patients)
* Participants currently having their symptoms well controlled with a stable dose of oral antipsychotic medication
* Participants who have signed informed consent form Exclusion Criteria:
* Participants who have never received any previous antipsychotic treatment
* Participants who have received clozapine during the last 3 months
* Participants with a serious unstable medical condition, including laboratory abnormalities
* Participants with a history of, or current symptoms of tardive dyskinesia (a complication of neuroleptic therapy involving involuntary movements of facial muscles) or neuroleptic malignant syndrome (a rare psychotropic-drug reaction, which may be characterized by confusion, reduced consciousness, high fever or pronounced muscle stiffness)
* Female participants who are pregnant or breast-feeding, or are of childbearing age without adequate contraception
Seroprevalence of Kaposi's Sarcoma Herpes Virus in the United States

This study will investigate patterns of Kaposi's sarcoma herpes virus (KSHV) in the United States and its potential impact on the U.S. population. KSHV is a newly discovered virus that is strongly associated with Kaposi's sarcoma and primary effusion lymphoma. The high prevalence of KS and KSHV among HIV-infected homosexual men suggests sexual contact as a primary mode of transmission. Reports of non-sexual transmission in parts of Africa and the Mediterranean where Kaposi's sarcoma is endemic, and the identification of viral DNA in saliva and other bodily fluids, however, indicate the virus is also transmitted non-sexually. This study will:

* Compare the prevalence of KSHV among different demographic groups in the United States
* Examine the association between KSHV and high risk behaviors such as drug use (marijuana and cocaine), sexual behavior (age at first sexual intercourse and number of sexual partners), and medical risk factors (herpes simplex virus II, hepatitis B and hepatitis C)
* Estimate the prevalence of KSHV in the United States.

Data and blood samples for the study will be taken from the NHANES III survey. NHANES is a program of periodic surveys conducted by the Centers for Disease Control and Prevention's National Center for Health Statistics. The survey is designed to provide national estimates of health status for the United States non-institutionalized civilian population by means of household interviews, standardized physical examinations, and blood sample collection and testing. NHANES III-the seventh in a series of national examination studies-was conducted from 1988 to 1994.

This study will use the HANES data to identify risks associated with a KSHV-positive blood test in the survey population. The study plans to include all 19,754 participants (67% of the 29,314 participants originally examined) for whom blood samples were collected and remain available.

Kaposi sarcoma herpesvirus (KSHV) is the viral cause of Kaposi sarcoma. Although infection with this virus appears to be uncommon in the United States, the prevalence in the general population in uncertain, and routes for transmission are poorly characterized. This study makes use of questionnaire data and serum specimens obtained in the third National Health and Nutrition Survey (NHAnes III). Sera from 18,168 individuals in this study were tested for antibodies to the KSHV proteins K8.1 and LANA. We will use these measurements to estimate KSHV seroprevalence for the overall U.S. general population and for demographic subgroups. To characterize potential transmission routes, we will also examine whether KSHV seroprevalence is related to sexual activity and exposures to blood, as indicated by responses to questionnaire items and previous NHANES III measurements of markers of relevant viral infections.

Eligibility Criteria:
* No specific eligibility criteria was provided for this protocol.
Open, Randomized, Two Way Crossover 40mg, Orally and Intravenously

This study looks at the effect on basal and pentagastrin-stimulated acid output of 40 mg Esomeprazole (Nexium) administered orally and intravenously as a 15-minute infusion to people with symptoms of Gastroesophageal Reflux Disease (GERD)


Eligibility Criteria:
Inclusion Criteria:

1. Heartburn on at least 2 days of the past 7 days prior to screening, with or without a history of EE or a documented diagnosis of GERD within 6 months prior to screening, with or without a history of EE.
2. Body mass index (BMI) of ≥18.5 and ≤35 kg/m2. \[BMI will be calculated using the following formula: weight (kg)/height (m)2.\]
3. Able to communicate with the investigator and to understand and comply with the requirements of the study.

Exclusion Criteria:

1. History of esophageal, gastric, or duodenal surgery, except for simple closure of an ulcer.
2. History of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis.
3. Any significant "alarm symptoms", within the past 6 months, such as, unintentional weight loss, gastrointestinal bleeding, jaundice or any other sign indicating serious or malignant disease.
4. Abnormal lab test results, as indicated in the protocol.
5. Other diseases, as indicated in the protocol.
Performance of Scoring Systems in Chinese Patients With Primary Biliary Cholangitis (PBC) on Ursodeoxycholic Acid

Several risk assessment scoring systems have been proposed to assess the therapeutic response and predict long term prognosis in ursodeoxycholic acid (UDCA)-treated primary biliary cholangitis (PBC) patients, in order to risk stratify PBC patients and guide their management. However there scoring systems have not been fully validated in Chinese population. This study is going to compare the prognostic ability of these criteria, validate the overseas scoring systems, develop and validate a new scoring system in a cohort of Chinese PBC patients.


Eligibility Criteria:
Inclusion Criteria:

* With liver biopsy proved PBC

Exclusion Criteria:

* A positive serological test for hepatitis B or C virus,
* Comorbidity of primary sclerosing cholangitis,
* Alcoholic liver disease,
* Hemochromatosis,
* Wilson's disease,
* a1-antitrypsin deficiency
* Presence of complications of cirrhosis (Total bilirubin \>100 lmol/L, ascites, variceal haemorrhage and hepatic encephalopathy) on admission.
Exer-game Balance Training on Dementia

Age-related cognitive impairment is a wide phenomenon. Mild cognitive impairment is a transitional stage between Dementia and normal cognition.Mild cognitive impairment (MCI) is a syndrome that has been recognized in older adults and it has become a topic of a major focus on clinical care and research. In people with this condition, there are cognitive deficits and these have adverse effects on activities of daily living . These patients cannot recognize their impairment. Mild cognitive impairment is a risk factor for dementia.

The clinical features of MCI are memory impairment along with language or speech impairments, executive functions, and visuospatial impairments. In regard to clinical features of Mild cognitive impairment (MCI), there are motor problems as patients have difficulty in doing complex motor tasks like doing pegboard assembly and also in fine and gross motor skills performance like they have difficulty in maintaining balance and body weight. Major factors contributing to mild cognitive impairment or major causes are medical conditions like hepatic or renal failure, depression, sleep disturbances, psychological problems,s and medicine side effects. impaired attention and concentration can lead to impaired memory and a decline in cognitive function.

As literature supports the evidence of the effectiveness of Exergaming in adults with neurocognitive disorders.As Exer-gaming training program improved their lower extremity functioning, cognitive function, and reduced depression, neuropsychiatric symptoms too. Recent studies on the treatment of Exergaming and its effect on the quality of life in dementia approach the standing balance Exer-gaming being effective and has increased attention, concentration, memory, and reaction time and has improved physical, cognitive, emotional, social function and quality of life and decreased the level of frailty in dementia patients. Recent literature on Exergaming has successfully improved cognition, balance,gait, and verbal memory in MCI patients and reduced fall risk in older adults of age \>55 years

Eligibility Criteria:
Inclusion Criteria:

* Individuals \>55 years of age.
* Patients meeting mild cognitive impairment (MCI), The Montreal Cognitive Assessment (MoCA) 20-24.
* clinical dementia rating scale (CDR) ≤ 1.0
* No unstable disease precluding the planned exercise
* Able to see and hear sufficiently to participate in planned physical and computer-based cognitive training

Exclusion Criteria:

* Non-ambulatory or major mobility disorder;
* Other neurological conditions associated with cognitive impairment such as stroke, Parkinson disease, and head injury
* Any clinically significant psychiatric condition, current drug or alcohol abuse, that would interfere with the ability to participate in the study
* Severe visual impairment
* Unwillingness to participate
Relief Band as an Adjunct to Antiemetic Therapy in Patients Who Receive Mod to Highly Emetogenic Chemotherapy

The primary study hypotheses are that, without increasing doses of breakthrough medications or device intolerance, the Nometex™ device worn for 5-days beginning with the day of chemotherapy administration in women with ovarian or advanced endometrial or cervical cancer will, as an adjunct to standard-of-care anti-emetics, reduce vomiting episodes, and reduce the severity of nausea.

The secondary hypotheses are that the Nometex™ device reduces acute (Day 1) emetic episodes, day 1 and days 2-5 severity of nausea, and delayed (days 2-5) emetic episodes without increasing doses of breakthrough medications or device intolerance.


Eligibility Criteria:
Inclusion Criteria:

1. Women with ovarian (including fallopian tube) or advanced endometrial or cervical cancer
2. Chemotherapy-naïve or who have had previous chemotherapy exposure, but who have not yet received the first infusion
3. 18 years of age or older, and can provide cognizant informed consent presenting to the Helen F. Graham Cancer Center
4. ECOG Status of 0-2
5. Standardized Antiemetic Regimen

Exclusion Criteria:

1. Pre-existing or at-risk for a peripheral neuropathy in region of device placement
2. Implanted cardiac pace maker
3. Nickel or other metal allergies
4. Previous experience with median nerve/P6 stimulation
5. Receiving concurrent radiation therapy
6. Previous participants of this study will be excluded from future participation in this study.
Effect of Preemptive Education on the Incidence of Maternal Intraoperative Shivering in Elective Cesarean Delivery

The goal of this study is to learn about the effect of preemptive education on reducing intraoperative maternal shivering in elective cesarean delivery. The main question it aims to answer is:

Does preemptive education by anesthesiologists reduce intraoperative maternal shivering in elective cesarean delivery?


Eligibility Criteria:
Inclusion Criteria:

* Age 19 years or older
* Gestational age 37 weeks or above
* Elective surgey

Exclusion Criteria:

* Emergency surgery
* Any sign of onset of labor
* Difficulty with communication
* Contraindications of spinal anesthesia
* Pre-eclampsia
Directional Versus Nondirectional DBS for ET

This will be a single center (OHSU) proof of concept trial to demonstrate that directional deep brain stimulation (DBS) creates a larger therapeutic window for the treatment of essential tremor (ET), effectively treats ET, and minimizes effects on speech, gait and balance compared to nondirectional DBS.

Specific Aims:

1. To compare the therapeutic window (TW) of directional versus nondirectional deep brain stimulation for treatment of tremor.

   Hypothesis: directional DBS will result in a wider TW than nondirectional DBS.
2. To compare the effects of directional versus nondirectional DBS on speech Hypothesis: Objective and subjective speech impairment will occur to a greater extent in nondirectional DBS versus directional DBS optimized for tremor control.
3. To compare the effects of directional versus nondirectional DBS on balance and gait Hypothesis: Objective and subjective balance and gait impairment will occur to a greater extent in nondirectional DBS versus directional DBS optimized for tremor control.
4. To assess efficacy for tremor of nondirectional and directional DBS in an optimized programming configuration Hypothesis: both directional and nondirectional DBS will significantly improve tremor compared to baseline.

Eligibility Criteria:
Inclusion Criteria:

* A tremor syndrome of bilateral upper limb action tremor with at least 3 years' duration

Exclusion Criteria:

* Patients who have decided not to receive DBS for control of their medication-refractory essential tremor.
* Patients with secondary tremor (ie not Essential Tremor), such as side effects from medications, secondary to another identified neurologic disease (eg multiple sclerosis, -----Parkinson's disease, dystonia).
* Prior history of deep brain stimulation.
* Prior history of thalamotomy.
* A history or signs of dystonia, ataxia or parkinsonism.
* Task specific tremor.
* Orthostatic tremor.
* Patients with cardiac pacemakers, defibrillators, or neurostimulators.
* Patients who require MRI, ECT, rTMS, or diathermy.
* Subjects with other type of neurological disease or injury.
Clinical Study on the Efficacy and Safety of Multiple Oral Administrations of SHR2285 Tablets in Patients Undergoing Elective Total Knee Arthroplasty

This study is a multi-center, randomized, open-label, double-blind, positive-controlled phase II clinical study evaluating the efficacy and safety of different doses of SHR2285 tablets vs. enoxaparin for the prevention of postoperative venous thromboembolism in patients undergoing elective unilateral total knee arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

1. Understand the study procedures and methods, voluntarily participate in the study, and sign the written informed consent form (ICF);
2. Scheduled to undergo elective unilateral total knee arthroplasty;
3. Males or females aged 40-75 years.

Exclusion Criteria:

1. Weighing less than 40 kg or greater than 135 kg;
2. Allergic to contrast agents rendering the patient unable to undergo venous angiography of the lower extremities; allergic to enoxaparin or any of the ingredients listed in the package insert thereof; allergic to the investigational product or any of the ingredients thereof;
3. With malignant tumors that still require medical intervention; except for radically treated non-melanoma skin cancer, basal cell carcinoma or squamous cell skin cancer, or cervical carcinoma in situ;
4. With a history of major liver disease within 1 year;
5. With myocardial infarction, transient ischemic attack, or ischemic stroke within 6 months.
Impact of Protamine Dose Reduction on Platelet Aggregation After Extracorporeal Circulation for Minimally Invasive Aortic Valve Replacement Surgery

Determining the minimum effective dose of protamine after extracorporeal circulation for mini-sternotomy aortic valve replacement surgery.


Eligibility Criteria:
Inclusion Criteria:

* Mini-sternotomy aortic valve replacement surgery
* Major patients

Exclusion Criteria:

* Hypersensitivity to protamine
* Coagulation Abnormalities
* Heparin allergy
* Pregnant women
* Jehovah's Witnesses