cyrilzakka/clinical-trials huggingface dataset:
Albiglutide Thorough ECG Study in Healthy Volunteers

This study is designed to investigate the effect of treatment with albiglutide on the cardiac repolarization (corrected QT interval) in healthy male and female subjects. Moxifloxacin, a positive control, or moxifloxacin placebo will be given in order to validate the ability of the study to detect a change in the corrected QT interval.

This is a Phase I, randomized, double-blind study designed to investigate the effect of treatment with albiglutide given weekly over 6 weeks on the cardiac repolarization (corrected QT interval) in healthy male and female subjects. Moxifloxacin, a positive control, or moxifloxacin placebo will be given in order to validate the ability of the study to detect a change in the corrected QT interval.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or nonpregnant, nonlactating female
* Subject considered to be in good health as judged by the absence of clinically significant diseases or clinically significant abnormal laboratory values
* BMI is ≥18 kg/m2 and ≤30 kg/m2
* Nonsmoker

Exclusion Criteria:

* Positive test results for hepatitis B, hepatitis C, or human immunodeficiency virus
* History of arrythmia or use of antiarrhythmic agents
* History of any anaphylactic reaction to any drug
* History of significant cardiovascular or pulmonary dysfunction
* Current or chronic history of liver disease , renal disease, CNS disorders, thyroid dysfunction, rheumatoid arthritis
* History of alcohol or substance abuse
* History of GI surgery that could influence gastric emptying
* Female and using oral contraception (combined or progestogen only), implants or levonorgestrel, or injectable progesterone, or hormone replacement therapy
* History of pancreatitis
Characterization of Immune Semaphorin in Non Alcoholic Fatty Liver Disease and NASH

Recent epidemiological studies in France showed a high prevalence of obesity (14.5%) and its strong increase in the last 20 years. Among the many complications associated with obesity, liver complications (steatosis and steatohepatitis \[NASH\]) are among the most common. Semaphorins were described in the early 1990. More than 20 types of these proteins have been reported to date. These proteins were used for neural development. Since many functions have also been described. The semaphorins are involved in numerous physiological or physiopathological processes (cardiac morphogenesis, vascular growth, tumor progression), the regulation of immune cells and liver fibrosis. Preliminary studies have allowed to show that dendritic cells infiltrate adipose tissue and initiate the activation of T cells and inflammation. Immune semaphorin are new players in the regulation of inflammation and immune reactions.

The role of immune semaphorin in regulating inflammation in the two compartments (liver and adipose tissue) could be a crucial step that could lead to more severe liver damage. Its dysregulation could explain NASH injuries. The goal is to identify a new mode of regulation of cellular homeostasis in the fatty liver disease. These factors may serve as diagnostic markers or future therapeutic targets.


Eligibility Criteria:
Morbid obese patients

Inclusion Criteria:

* Male and female aged 18-65 years
* Patients with body mass index justifying a surgery for obesity (BMI ≥ 40 kg / m2 or BMI ≥ 35 kg / m2 with comorbidities)
* Consumption of alcohol \<20 g / d
* Patients affiliated to a social security insurance
* Patients who signed the informed consent

Exclusion Criteria:

* Hemochromatosis
* Toxic hepatitis
* Deficiency of alpha-1-antitrypsin
* Wilson's disease
* Liver Autoimmune disease (primary biliary cirrhosis, autoimmune hepatitis)
* Hepatitis B, C
* Drug-induced hepatitis
* Presence of HIV status
* Corticosteroids, amiodarone, valproic acid, tamoxifen, anti-inflammatory drugs, lipid lowering agents, testosterone agonists or beta-adrenergic antagonists, orlistat.
* Pregnant or breastfeeding women
* Incarcerated patients or patient under guardianship
SMART Identification of Ventricular Tachycardia Isthmus

Context :

Ventricular tachycardia (VT) are serious heart rhythm disorders which can lead to sudden death. A curative treatment for these abnormalities in the cardiac electrical conduction system is possible through an interventional electrophysiology procedure. A catheter is inserted, generally via a femoral access, and is introduced in the heart ventricles in order to collect various 3D electro-anatomical maps.

The pace-mapping technique developed in Nancy (de Chillou et al, Heart Rhythm 2014) allows the reentrant circuit underlying the VT to be identified, as well as a definition of the target zones to be ablated, using radiofrequency energy with the catheter. The pace-mapping technique consists of stimulating the ventricle from various sites within its internal surface, in order to generate different activation pathways of the myocardium. When an activation pathway is similar to the VT pathway, this means that the stimulation site is located near the pathologic zone to be ablated. The surface electrocardiogram (ECG) is used to compare activation pathways. A 3D correlation ma is then generated: the zones with high correlation (\>90%) indicated the exit of the reentrant circuit, while rapid transition zones (several %/mm) indicate the entrance of the VT circuit. The pace-mapping technique has several limitations: (i) it requires an ECG recording of the clinical VT of the patient (spontaneous or induced at the beginning of the procedure), however it is not always possible to induce it; (ii) sometimes several VT circuits may be present, rendering the procedure of identification and ablation non-exhaustive.

The aim of this study is to analyze retrospectively electroanatomical data collected during the intervention, in order to develop a new method for identifying target zones to be ablated, and to compare the results with the conventionally used method.

Hypothesis :

The investigators hypothesize that alternative methods to analyze electroanatomical data (surface ECG and spatial coordinates of the pacing sites) could provide information equivalent to conventional methods (e.g. VT correlation map, VT activation maps etc...) without the need for a reference recording of the clinical VT of the patient.


Eligibility Criteria:
Inclusion Criteria:

* Ventricular tachycardia ablation between October 2014 and April 2021
* Patient for whom electroanatomical data are available.
* Ischemic cardiomyopathy / previous myocardial infarction
* At least 30 points of pace-mapping during the VT procedure

Exclusion Criteria:

* Incomplete data
* Poor quality ECG recordings
* Absence of ventricular tachycardia isthmus identified during the procedure
Drug Concentration of Metformin According to Sampling Method

This study assess the drug concentration of metformin in healthy adult volunteers according to the sampling method.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects who, at the time of screening, are the age of older than 19 years
* Subjects who have BMI more than 17.5kg/m2 and less than 30.5kg/m2 and body weight more than 55kg
* There is no congenital disease or within 3 years of chronic diseases
* Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, ECG or clinical laboratory tests
* Subjects who signed and dated the informed consent form(approved by IRB) after understanding fully to hear a detailed explanation in the clinical trial

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
* A subject with any history of gastrointestinal disease (e.g., Crohn's disease, acute or chronic pancreatitis, and others) and surgery (except for simple appendectomy or repair of a hernia), which can influence the absorption of investigational products
* A subject who has the following clinical laboratory test results Liver Function Test (AST, ALT) \> two times the upper limit of the normal range
* History of regular alcohol consumption exceeding 210g/week(12g = 125 mL of wine, 10g = 250 mL of beer, 10g = 50 mL of hard liquor) within 6 months of Screening
* A subject who has participated in any other clinical trials and had medication within 3 months prior to the first administration of investigational product.
* A subject with a history of drug abuse or a positive urine drug screening for drug abuse within 1 year
* A subject who has taken the drugs that induce and suppress drug- metabolizing enzymes within 30 days prior to investigational product administration
* A smoker who consumes more than 20 cigarettes/day within 6 months
* A subject who has taken any ethical-the-counter drug or has taken any over- the-counter drug within 10 days before the investigational product administration
* A subject who has donated whole blood within 2 months or blood components within 1 month prior to the investigational product administration
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation
Predictors for Low Rates of Surgical Resection in Elderly Patients With Resectable Pancreatic Ductal Adenocarcinoma

More and more older adults are diagnosed with pancreatic ductal adenocarcinoma (PDAC), but the rate of surgical resection in patients with resectable tumour is still low. Clinical workers need to take more attention to oncologic care in this group. It's significant to explore potential predictors for impacting elderly patients chose to abandon surgical resection.

The incidence of pancreatic ductal adenocarcinoma (PDAC) in the elderly has been on the rise, but the elderly were always neglected in clinical oncology care. Pancreatic ductal adenocarcinoma is a lethal disease, and the most effective treatment for curing it remains the radical resection. Unfortunately, there are many a study had reported that the rate of radical surgery of patients with PDAC has been low in the past decade. In order for more elderly pancreatic cancer patients to undergo surgical resection, investigators extracted the data of elderly patients with PDAC from SEER program and investigated predictive factors associated with surgical resection abandonment. In this study, investigators extracted data of patients older than 75 years diagnosed with T1-T3 stage PDAC to investigate rate of radical surgery. And researchers used Univariate and multivariate logistic regression model to explore potential factors associated with patients and surgeon chose to abandon surgical resection.

Eligibility Criteria:
Inclusion Criteria:

1. patients older than 75 years old and were diagnosed with pancreatic ductal adenocarcinoma by positive histology.
2. Patients were diagnosed with T1 through T3, M0 tumor based on criteria of TNM stage.

Exclusion Criteria:

1. Patients were diagnosed by death certificate.
2. Patients died before radical surgery.
3. Patients with important data missing, such as T-stage, surgical resection status, surgery procedures and complete survival time.
Effect of Breastfeeding Training Program and System (BMUM) for Mothers

The goal of the study was to investigate effect of breastfeeding training program and nurse-led breastfeeding online counselling system (BMUM) on mothers' breastfeeding self-efficacy, breastfeeding attitudes, breastfeeding problems and postpartum depression we hypothesized that there would be differences between BG and CG groups in terms of breastfeeding self-efficacy, breastfeeding problems, postpartum depression and breastfeeding frequency. This was a randomized controlled trial. Participants were randomly assigned to the breastfeeding group (BG; n = 36), or control group (CG; n = 36). Control group will receive only standart care breastfeeding group will receive standart care and web based breastfeeding support. Breastfeeding attitudes, infant feeding attitude breastfeeding problems and postpartum depression will assessment. The assesment point will be 32-37 gestational week, postpartum 1st day, 1st week, 3 months, and 6 months.


Eligibility Criteria:
Inclusion Criteria:

* 18-35 years old,
* Primipara with a singleton pregnancy
* 32- and 37-weeks of gestation,
* Willingness to participate in the workshop program

Exclusion Criteria:

* Having a chronic illness
* Having pre-term labor or an abnormal fetal screening
* Had a psychiatric disorder or anxiety disorder
* Having any other high-risk complications
Spironolactone and Dexamethasone in Patients Hospitalized With COVID-19

The Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV-2) is a rapidly spreading infection of the respiratory tract. Most infected patients have either asymptomatic disease or mild symptoms. However, a proportion of patients, especially elderly men or patients with comorbidities, are at risk of developing acute respiratory distress syndrome (ARDS). ARDS, alongside clotting abnormalities, is known to be a major contributor to SARS-CoV-2-related mortality and admission to intensive care units, with evidenced effective preventative treatment options lacking. In this study, the investigators test a novel hypothesis that the use of a combination of spironolactone and dexamethasone at low doses will improve the clinical progression of the infection evaluated by the 6-point ordinal scale in patients with moderate and severe disease by blocking exocytosis of the Weibel-Palade bodies from endothelial cells.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or above;
* Signed informed consent;
* PCR-confirmed diagnosis of SARS-CoV-2 infection
* Presenting with moderate-to-severe disease (scores 4-6 on WHO ordinal scale)

Exclusion Criteria:

* Women of childbearing age without a negative urine pregnancy test, currently pregnant or breastfeeding women;
* Severe heart failure (NYHA4), severe renal failure (eGFR \< 30 ml/min/1.73 m2), severe liver failure (ALT/AST ratio \> 5 norms), severe anemia (haemoglobin \< 30 g/l)
* Participating in another clinical trial
* Severe electrolyte imbalance (hyperkalemia \> 5.0 mmol/l, hyponatremia \< 120 mmol/l)
* Hypersensitivity or contraindications to the study drugs (spironolactone and dexamethasone)
* Renal dialysis
* Severe uncontrolled diabetes mellitus
* Patient receiving one of the following medications that cannot be substituted over the trial duration: ACE inhibitors, amiloride, eplerenone, cortisone acetate, potassium canrenoate, triamterene
Noninvasive Electrical Stimulator as a Pain Control Treatment Post-ureteroscopy

The investigators will assess the use of Transcutaneous Neurostimulation (TENS), a pharmacological alternative, for treatment of ureteral stent pain post-ureteroscopy. The primary aim for the investigators is to determine if use of a TENS unit will reduce post-operative pain and nausea associated with the ureteral stent. Secondary aim will be to assess if it can help minimize narcotic use.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing standard of care ureteroscopy and laser lithotripsy for urinary stone disease
* Patients receiving a stent following their ureteroscopy and laser lithotripsy

Exclusion Criteria:

* Children
* Pregnant patients
* Patients unable to answer pain questionnaire
* Patients undergoing PCNL
* Patients being treated for Urologic malignancy with ureteroscopy
* Patients who require long term or chronic ureteral stent management
* Patient with implantable stimulators
* Patient with epilepsy
* Patients undergoing laser lithotripsy without stent placement
Dose Optimization for Stroke Evaluation

This study is about rehabilitation of arm function after a stroke. The investigators are testing the dosage of therapy that is needed for meaningful recovery of arm and hand function. Dosage of therapy refers to the amount of time (in this case, the total number of hours) that a person participates in treatment. The investigators hope to learn how much therapy time is needed in order for change to occur in arm and hand function after a person has had a stroke. Eligible candidates must have had a stroke affecting the use of an arm or hand at least 6 months ago.


Eligibility Criteria:
Inclusion criteria:

* Ischemic or hemorrhagic stroke that occured at least 6 months ago.
* At least 21 years of age
* Persistent arm and hand weakness, with some ability to release a grasp
* Able to provide consent to participate
* No history of a medical condition that limited arm or hand use prior to the stroke
* Medically stable
* Able to participate for 10 months and attend evaluations at the University of Southern California (USC) Health Sciences Campus.
* Able to communicate in English or Spanish.

Exclusion criteria:

* Severe upper extremity sensory impairment
* Neglect
* Current major depressive disorder
* Severe arthritis or orthopedic problems that limit arm or hand movement
* Pain that interferes with daily activities
* Currently enrolled in other rehabilitation or drug intervention studies
* Living too far from the training site to participate reliably
* Receiving oral or injected anti-spasticity medications during study treatment.
* Pregnancy.
Safety and Immunogenicity of the Candidate Vaccine MVA-MERS-S_DF-1 Against MERS

The study will be a two center, randomized, double blind, placebo controlled study of the MVA MERS S_DF-1 candidate delivered by i.m. injection. To evaluate the MERS-S-specific antibody responses and safety profile induced by the two dosage levels of MVA-MERS-S_DF-1 the data will be compared to a placebo control group.

This will be a Phase Ib, two-center study in approximately 160 healthy adults aged 18-55 years

The study is separated in two parts:

Part A:

The study starts with a single center open-label run-in phase of two dose levels (cohort 1 "low dose": 2x10\^7 PFU, cohort 2 "high dose": 2x10\^8 PFU) in 10 healthy subjects. 5 subjects will be allocated to each dose cohort and will receive immunization on day 0 and day 28.

Part B:

Two-center, randomized, double-blind, placebo-controlled, dose-finding study. This part is a double-blinded trial in approximately 150 healthy subjects. Subjects will be allocated to two different dose cohorts and a placebo cohort; each receiving three vaccine injections.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent form.
2. Healthy male and female subjects aged 18-55 years.
3. No clinically significant acute health problems as determined from medical history and physical examination at screening visit.
4. Body mass index 18.5 - 30.0 kg/m2 and weight \> 50 kg at screening.
5. Non-pregnant, non-lactating female with negative pregnancy test.
6. Males and females who agree to comply with the applicable contraceptive requirements of the protocol.

Exclusion Criteria:

1. Receipt of any vaccine from 2 weeks prior to each trial vac-cination (4 weeks for live vaccines) to 3 weeks after each trial vaccination.
2. Receipt of vaccination against MERS or MVA immunizations.in the medical history.
3. Known allergy to the components of the MVA-MERS-S_DF-1 vaccine product.
4. Evidence in the subject's medical history or in the medical examination that might influence either the safety of the subject or the absorption, distribution, metabolism or excretion of the investigational product.
5. Any confirmed or suspected immunosuppressive or immuno-deficient condition, cytotoxic therapy in the previous 5 years, and/or diabetes.
6. Any chronic or active neurologic disorder, including seizures and epilepsy, excluding a single febrile seizure as a child.
Promotora-Led Physical Activity Intervention Trial for Latinas in Texas

The purpose of this study it to determine if a promotora-led intervention that takes a comprehensive, multi-level, community-based approach to promoting physical activity (PA) is effective among a particularly underserved segment of Latinas. We hypothesize that Latinas in the promotora-led PA Intervention will significantly increase minutes per week of moderate-to-vigorous physical activity (MVPA) compared to Latinas in the attention-control group.


Eligibility Criteria:
Inclusion Criteria:

* women ages 18-64 years
* self-identify as Hispanic
* have a personal telephone
* reside within and intend to stay in the specified areas over the entire study period
* understand Spanish
* do not currently meet national PA recommendations

Exclusion Criteria:

* currently pregnant or plan to become pregnant
* insulin dependent diabetic
* uncontrolled hypertension
* undergoing therapy for life-threatening illnesses (chemotherapy or radiation therapy)
* positive (risk) responses on the PA Readiness Questionnaire (PAR-Q) and subsequent physician disapproval
A Tolerance Trial of Cinobufacini Injection Intraperitoneal Perfusion on Digestive System Cancer With Ascites

To evaluate the tolerance and safety of cinobufacini injection intraperitoneal treatment on digestive system cancer patients with malignant ascites, and propose dosage regimens for future clinical trials. The clinical trial is divided into two parts, including single and successive administration.

To evaluate the tolerance and safety of cinobufacini injection intraperitoneal treatment on digestive system cancer patients with malignant ascites, and propose dosage regimens for future clinical trials. A single-arm, non-randomized, open, drug tolerance trial will be conducted. The clinical trial is divided into two parts, including single and successive administration.The single administration includes 7 groups, dose is escalated from 15ml to 180ml, with 2-6 patients per dose level. Central venous catheters will be preserved for drainage of ascites, after the drainage of most of ascites, we will slowly inject a dilute concentration of cinobufacini injection with escalated dosage through the catheters. This treatment will be given only once, and the volunteers will be observed for 24 hours. Then we will evaluate the observation indexes, including adverse events, vital signs, electrocardiogram, blood routine, urine routine, hepatic and renal function, etc. The successive administration includes 2 groups, according to the result of single administration, choose the second largest tolerance dose to conduct the 1st group of successive administration. If there are significant adverse effects, then drop to a lower dose to conduct the 2nd group; if the trial shows no adverse effects, it upgrades to a higher dose (the maximum tolerated dose) to conduct the 2nd group. The treatment will be given 3 times a week, 2 weeks as a period. Adverse effects will be evaluated during and after treatment.

Eligibility Criteria:
Inclusion Criteria:

1. digestive system cancer with malignant ascites;
2. the age of 18-80 years;
3. neither systemic chemotherapy, nor peritoneal perfusion therapy in 2 weeks;
4. no cinobufotalin preparations in 2 weeks;
5. ECOG score 0-3;
6. the amount of ascites is above level II (1000-3000ml);
7. volunteer to participate and sign informed consent.

Exclusion Criteria:

1. non-cancer causes of ascites, such as peritonitis, cirrhosis，hypoalbuminemia;
2. Had an allergy history to toad's skin or its products or had adverse reactions like arrhythmia when applied before;
3. B ultrasound or CT confirmed the peritoneal cavity is separated which will affect the treatment of ascites and the estimation of ascites;
4. The conditions admit and the patients would better to undergo chemotherapy of malignant ascites;
5. cardiac function is Ⅲ-Ⅳ;
6. ALT\> 3 times upper limit and / or TBIL\> 2 times upper limit;
7. renal function is phase 3 and above 3;
8. have severe neutropenia of degree II or above, and / or moderate or severe anemia, and / or thrombocytopenia of degree II or above;
9. Consolidated mental disorders.