cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetics of Insulin Detemir in Healthy Volunteers From Taiwan

This trial is conducted in Asia. The aim of this trial is to investigate pharmacokinetics of insulin detemir in healthy Taiwanese subjects.


Eligibility Criteria:
Inclusion Criteria:

* Considered generally healthy upon completion of medical history and physical examination as judged by the investigator
* Body mass index (BMI) between 18 and 27 kg/m\^2, inclusive
* Fasting plasma glucose maximum 6.1 mmol/l
* Non-smoker or smoking maximum 5 cigarettes per day or the equivalent

Exclusion Criteria:

* Participation in any other clinical trial involving other investigational products within the last 3 months
* Subject with a history of alcohol or drug dependence
* Subject with a first-degree relative with diabetes mellitus
A Study With Clevudine Monotherapy or Adefovir and Clevudine Combination in Proportion to Roadmap Concept in Patients With HBV Associated-HCC

An open study to evaluate the Efficacy, Safety of Clevudine monotherapy or Adefovir and Clevudine combination in Proportion to Roadmap Concept in patients with chronic hepatitis B Associated Hepatocellular Carcinoma


Eligibility Criteria:
Inclusion Criteria

1. Patient with chronic HBV DNA and/or with symptoms of liver cirrhosis
2. Patient with Hepatocellular carcinoma evidenced by sonography, CT scan, or MRI scan)
3. Patient is 18 years and older.
4. Patient is documented to be HBsAg positive for \> 6 months.

   * Laboratory report proving HBsAg positive or HBeAg positive for at least six months
   * IgM anti-HBc negative, IgG anti-HBc positive at screening
5. Patient is HBV DNA positive with DNA levels ≥ 2,000 IU/mL within 30 days of baseline.
6. Patient has ALT or AST levels \>=40 IU/L
7. Cell carcinoma/hepatocellular carcinoma patient who is anticipated to live at least 1 year.
8. Patient who is fully active, able to carry on all pre-disease performance without restriction or restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.
9. Patient who is classified as NYHA functional classification grade 1-2. (NYHA;New York Heart Association)
10. Patient who is able to give written informed consent prior to study start and to comply with the study requirements.

Exclusion Criteria

1. Patient is currently receiving antiviral therapy.
2. Patients previously treated with interferon, peg-interferon or other immunomodulatory within the previous 6 months.
3. Patients previously treated with clevudine, lamivudine, adefovir, entecavir, telbivudine, tenofovir or any other investigational nucleoside for HBV infection.
4. Patient is coinfected with HCV, HDV or HIV.
5. Patient with metastatic malignancy.
6. Patient with previous liver transplantation
7. Patient is pregnant or breast-feeding.
8. Patient has a clinically relevant history of abuse of alcohol or drugs.
9. Patient use oriental medicine within the previous 2 weeks.
10. Patient has a significant immunocompromised, gastrointestinal, renal, hematological, psychiatric, bronchopulmonary, biliary diseases excluding asymptomatic GB stone, neurological, cardiac, oncologic(except HCC)or allergic disease or medical illness that in the investigator's opinion might interfere with therapy.
11. Patient has creatinine clearance less than 60mL/min as estimated by the following formula: (140-age in years) (body weight \[kg\])/(72) (serum creatinine \[mg/dL\]) \[Note: multiply estimates by 0.85 for women\]
First-in-human Study to Assess the Safety and Pharmacokinetics of LML134 in Healthy Volunteers

Phase I study to assess the safety, tolerability and pharmacokinetics of ascending single and multiple doses of the investigational medicinal product in healthy volunteers


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects age 18 to 55 years of age included, and in good health as determined by medical history, physical examination, vital signs, electrocardiogram, and laboratory tests.
* Written informed consent must be obtained before any assessment is performed.
* Able to communicate well with the Investigator, to understand and comply with the requirements of the study.

Exclusion Criteria:

* History or presence of epilepsy or of seizures or convulsions of any kind.
* Any clinically relevant abnormalities identified in the resting EEG during screening, or pre-ictal signs or other clinically relevant abnormalities in the hyperventilation or intermittent photic stimulation EEG during screening.
* History of head trauma leading to clinically significant symptoms in the past two years.
* Applies only to subjects enrolled in Part 2 MAD. Score "yes" on item 4 or item 5 of the Suicidal Ideation section of the C-SSRS, if this ideation occurred in the past 6 months, or "yes" on any item of the Suicidal Behavior section, except for the "Non-Suicidal Self-Injurious Behavior" (item also included in the Suicidal Behavior section), if this behavior occurred in the past 2 years.
* Significant illness including any clinically significant infectious disease which has not resolved within two (2) weeks prior to initial dosing.
* History or presence of significant hematological abnormalities or immunodeficiency or any condition that might compromise the immune system (infection, vaccination), of any etiology as indicated by clinically significantly abnormal values of any of the following hematologic parameters: thrombocyte, RBC count, total WBC count and differentials presented as % of total white blood cell count and as absolute concentrations.
* History or presence of any thyroid disease as indicated by any clinically relevant abnormality on thyroid stimulating hormone test (TSH).
* History or presence of any chronic eye disease other than refractive error, strabismic amblyopia, or anisometropic amblyopia.
* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant.
A Study of Prolonged Electrocardiographic Monitoring in Patients With Heart Failure in Sinus Rhythm or Atrial Fibrillation

It is an observational study in patients with heart failure investigating the incidence of arrhythmias using a wearable device which can monitor heart rhythm for up to 14 days. In addition to gathering routine clinical information, research assessments include a symptoms questionnaire and a corridor walk test. Patients will be followed for clinical events (interventions for arrhythmias, hospitalisation, death) for 1 year.

due to the slow recruitment, on the one hand, and the fact that the preliminary analysis gave the valuable results, on the other hand, the number of patients was reduced from 400 to 100 and the follow-up from five years to one year

Eligibility Criteria:
Inclusion Criteria:

1. Heart Failure
2. Treated with Loop Diuretics for at least six weeks
3. Willing and legally able to sign informed consent
4. At least 18 years of age
5. New York Heart Association (NYHA) class II - IV

Exclusion Criteria:

1. Myocardial infarction in the previous six weeks,
2. Implanted pacemaker, including cardiac resynchronisation device, or defibrillator
3. Already participating in an interventional randomized controlled trial assessing effects on morbidity and mortality (this study does not preclude participation in future clinical trials).
A Single Ascending Dose Study of ACT-541468 in Healthy Male Subjects

The main objectives of this first-into-man study were to investigate the safety, tolerability and the pharmacokinetic profile of single oral doses of ACT-541468 in healthy male adults. Pharmacodynamic effects (through a battery of Central Nervous System tests) were also assessed.

The study consisted of ascending dose groups; each dose group was investigated in a new group of 8 healthy male subjects (6 on active drug and 2 on placebo). In addition, the study included a biocomparison part (dose group 2), an absolute bioavailability part (dose group 4), and a mass balance / metabolism part (dose group 3).

Eligibility Criteria:
Key inclusion Criteria:

* Signed informed consent prior to any study-mandated procedure.
* Males aged from 18 to 45 years (inclusive) at screening.
* Body mass index (BMI) between 18.0 and 30.0 kg/m2 (inclusive) at screening.
* Systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate (PR) between 100-145 mmHg, 50-90 mmHg and 45-90 bpm (all inclusive) at screening, respectively.
* Healthy on the basis of physical examination,electrocardiogram and laboratory tests.

Key exclusion Criteria:

* Known hypersensitivity to any excipients of the drug formulations.
* History or presence of any disease or condition or treatment, which may put the subject at risk of participation in the study or may interfere with the absorption, distribution, metabolism or excretion of the study drugs.
* History of narcolepsy or cataplexy or modified Swiss narcolepsy scale total score \< 0 at screening.
* Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol.
Effect of taVNS on Abdominal Pain and Other Symptoms in Constipation-predominant Irritable Bowel Syndrome

This study aims to investigate the effects and possible mechanisms of transcutaneous auricular vagal nerve stimulation (taVNS) on abdominal pain and other symptoms in patients with IBS-C.

This study is designed as an early-feasibility, single-center, single-blinded, randomized controlled trial (RCT), in which subjects are consented, undergo a baseline assessment, and receive taVNS or sham-taVNS treatment twice a day (8 a.m. and 8 p.m.) for 30 minutes each time for a period of 4 weeks. The taVNS and sham-taVNS treatment was applied using the commercially-available Transcutaneous Electrical Applicator device (Model SNM-FDC01, Ningbo MedKinetic Medical Device Co., Ltd.) with the skin electrodes placed bilaterally on auricular concha. The patients are requested to score the abdominal pain (using VAS) and complete BSFS, IBS-SSS, IBS-QOL, SAS, and SDS forms every week and fill out the bowel diary during taVNS or sham-taVNS. Emergency medications (Macrogol 4000 and pinaverium) are permitted for use when the patient cannot tolerate symptoms of constipation and abdominal pain.

Eligibility Criteria:
Inclusion Criteria:

1. willing to sign a written informed consent form
2. met the Rome IV diagnostic criteria for IBS-C

Exclusion Criteria:

1. history of previous abdominal surgery (other than appendectomy)
2. presence of carcinoma
3. any organic diseases causing constipation or neurologic diseases such as multiple sclerosis, rachischisis, Parkinson's disease, or spinal cord injury
4. taking antidepressant agents including tricyclic antidepressants and selective serotonin reuptake inhibitors
5. serious concomitant disease of the heart, liver, kidney, or diabetes
6. pregnancy or lactation
7. participating in another trial or enrolled in a trial during the past month
8. allergic reaction to surface electrodes
Effect of Bio-impedance Analysis and Vitamin D vs Usual Care on Left Ventricular Mass in Peritoneal Dialysis Patients: A Randomized Controlled Trial (FLUID Study)

The main purpose of this study is to compare the effects of using bio-impedance analysis to guide management of fluid status versus routine clinical care on heart structure. In addition, Vitamin D is being assessed to determine its effect on heart structure.

Patients on peritoneal dialysis are frequently hypervolemic which is associated with deleterious changes in left ventricular (LV) architecture including increased LV mass. In dialysis patients, increased LV mass is associated with death. Recent randomized trials have demonstrated that increasing small solute clearance is not associated with improved outcomes - hence an increased interest in the management of volume control in ESRD patients. Bioimpedance analysis is inexpensive, safe and easy to use and appears to be more useful than other techniques to assess volume status in dialysis patients. In addition, dialysis patients are vitamin D deficient and this is also associated with an increased LV mass and its inherent complications.

This study will evaluate the use of bioimpedance analysis versus usual care to assess and manage volume status and the use of vitamin D versus placebo in peritoneal dialysis patients and its effect on LV mass as measured by cardiac MRI.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* on peritoneal dialysis

Exclusion Criteria:

* Contraindication to MRI including presence of a pacemaker, defibrillator, ferromagnetic cerebral aneurysm clips, cochlear implants or eye prosthesis, neurostimulators, shrapnel in vital locations, surgery within 6 weeks, severe claustrophobia and severe obesity
* Previous amputation
* Life or technique expectancy \< 1 year
* Pregnancy
* Peritonitis in previous 3 months
* Currently using more than one extraneal bag per 24-hours
* Known icodextrin allergy
* Currently using non-Baxter PD solutions
* Inability to provide consent
* Allergy to cholecalciferol
* Serum Calcium \> 2.55 mmol/L
HFNC Flow Titration and Effort of Breathing in the PICU

High-flow nasal cannula (HFNC) is a method of non-invasive respiratory support used to decrease the effort of breathing (EOB) in patients with a wide variety of respiratory diseases in the pediatric intensive care unit. While its use has shown association with decreased rates of mechanical ventilation, there is a paucity of data examining its direct effect upon objective measurements of EOB. This study will aim to evaluate objective measurements of EOB in response to different levels of HFNC support, characterize the natural course of respiratory diseases treated with HFNC, evaluate changes in EOB secondary to the administration of supplemental medical therapies used in conjunction with HFNC, and compare different physiologic metrics for quantifying EOB in patients on HFNC.


Eligibility Criteria:
Inclusion Criteria:

* All participants less than or equal to three years old admitted to the PICU placed on high flow nasal cannula will be considered eligible for the study.

Exclusion Criteria:

* Participants will be excluded if they have a corrected gestational age less than 37 weeks or contraindications to nasoesophageal catheter placement (nasopharyngeal or esophageal abnormalities) or RIP bands (abdominal wall defects such as omphalocele). Patients greater than three years of age will be excluded.
Gene Expression and Biomarker Profiling of Keloid Skin

This study aims to examine both the genetic profile and the biomarkers implicated in keloid scar formation.

Hypothesis:

1. Differences in the genetic profiles of lesional and non-lesional skin contribute a given population's propensity to develop keloids
2. Differences in biomolecules expressed in subjects with and without keloids can help predict keloid occurrence and severity
3. Biomarker analysis will provide useful insights for future targeted therapies for keloid scars

Objectives:

1. Determine gene expression profiles of keloid scar tissue using samples collected longitudinally
2. Define and compare the molecular biomarkers of keloid scars in keloid (lesional) and non-lesional skin biopsies and serum samples from adult subjects

Eligibility Criteria:
Inclusion Criteria:

* Patient with an untreated keloid scar or a patient with a keloid scar that has not had treatment for at least 6 months before time of enrollment
* Patients without keloids coming into the dermatology clinic for a keloid unrelated issue (Group 5 only)

Exclusion Criteria:

* Patients who have had treatment of their keloid scar within 6 months of date of enrollment
Continuous Versus Intermittent Administration of Epidural Analgesia During Labor

prospective randomized single blind study, including full term adult parturients, ASA 2, 3 status, scheduled for vaginal delivery. patients were randomized at 3 cm of cervix dilatation, into 2 groups.

Epidural analgesia was initiated and maintained with a solution of Bupivacaine 0,125% and Sufentanil 0,25 mcg/ml. After an initial bolus of 16 ML, patients were randomly assigned to receive intermittent boluses of 8 ml every 60 minutes after the initial dose followed by supplementary PCEA boluses of 8 ml for the first group ( PCEA group) or a continuous epidural infusion at the rate of 8 ml/h adjustable and starting immediately after The initial bolus of 16 ml for patients of the second group (CEI Group).

prospective randomized single blind study, including full term adult parturients, ASA 2, 3 status, scheduled for vaginal delivery. patients were randomized at 3 cm of cervix dilatation, into 2 groups.

Epidural analgesia was initiated and maintained with a solution of Bupivacaine 0,125% and Sufentanil 0,25 mcg/ml. After an initial bolus of 16 ML, patients were randomly assigned to receive intermittent boluses of 8 ml every 60 minutes after the initial dose followed by supplementary PCEA boluses of 8 ml for the first group ( PCEA group) or a continuous epidural infusion at the rate of 8 ml/h adjustable and starting immediately after The initial bolus of 16 ml for patients of the second group (CEI Group).

The main outcome of this study was: the incidence of motor Blockage. Our secondary outcomes were: maternal satisfaction, local anaesthetic and sufentanil cumulated doses, duration of the second stage of labor, mode of delivery and pain during labor using the Visual analogic score (VAS score).

Eligibility Criteria:
Inclusion Criteria:

* Full term parturients scheduled for vaginal delivery

Exclusion Criteria:

* patients in whom cesarean section delivery was indicated during labor
A Pharmacokinetic And Safety Study Of Voriconazole In Healthy Male And Female Adults

This study is to assess the plasma concentration-time profile of voriconazole in adults receiving 7-day intravenous treatment and 6.5-day oral treatment. This study is also to assess the safety profile of voriconazole during the treatment period.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects from 18 and 55 years old.
* Body weight between 40 kg (88 lbs) and 100 kg (220 lbs).

Exclusion Criteria:

* Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, ocular, neurologic, or allergic disease.
* Subjects with any condition possibly affecting drug absorption, eg, gastrectomy.
* Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication.
Preliminary Study Concerning the Validity of Parathyroid Exploration on a CZT Camera

The goal of this study is to assess the performance of parathyroid imaging on a cardiac-dedicated CZT camera, compared to planar pinhole imaging, in patients referred for primary hyperparathyroidism.

The goal is to determine if parathyroid tomoscintigraphy on a CZT camera can provide at least equivalent diagnostic performance, compared with planar pinhole imaging.

Eligibility Criteria:
Inclusion Criteria:

* suffering from sporadic primary hyperparathyroidism
* referred to the Nuclear Medicine Dept for a pre-operative scintigraphy of the parathyroid glands
* who have given their written consent
* who benefit from the French Government Medical Insurance

Exclusion Criteria:

* pregnant women
* ages \< 18 or \> 80 years
* hyperparathyroidism recidive after a first surgery
* secondary or tertiary hyperparathyroidism
* Multiple endocrine Neoplasia (MEN) type I context or familial history of hyperparathyroidism
* absence of written consent
* non-beneficiary of the French Government Medical Insurance
FlowTriever Pulmonary Embolectomy Clinical Study

Evaluate the safety and effectiveness of the FlowTriever System for use in the removal of emboli from the pulmonary arteries in the treatment of acute pulmonary embolism.


Eligibility Criteria:
Inclusion Criteria:

* Clinical signs, symptoms and presentation consistent with acute PE
* PE symptom duration ≤ 14 days
* CTA evidence of proximal PE
* RV/LV ratio ≥ 0.9 without syncope
* Systolic BP ≥ 90 mmHg
* Stable heart rate \<130 BPM prior to procedure
* Patient deemed medically eligible for interventional procedure(s), per institutional guidelines and/or clinical judgment

Exclusion Criteria:

* Thrombolytic use within 30 days of baseline CTA
* Pulmonary hypertension with peak PAP \> 70 mmHg by right heart catheterization
* Vasopressor requirement after fluids to keep pressure ≥ 90 mm Hg
* FiO2 requirement \> 40% or \> 6 LPM to keep oxygen saturation \> 90%
* Hematocrit \< 28% within 6 hours of index procedure
* Platelets \< 100,000/µL
* Serum creatinine \> 1.8 mg/dL
* INR \> 3
* Major trauma ISS \> 15
* Presence of intracardiac lead in right ventricle or atrium placed within 6 months
* Cardiovascular or pulmonary surgery within last 7 days
* Actively progressing cancer
* Known bleeding diathesis or coagulation disorder
* Left bundle branch block
* History of severe or chronic pulmonary arterial hypertension
* History of chronic left heart disease with left ventricular ejection fraction ≤ 30%
* History of uncompensated heart failure
* History of underlying lung disease that is oxygen-dependent
* History of chest irradiation
* History of Heparin-induced thrombocytopenia
* Any contraindication to systemic or therapeutic doses of heparin or anticoagulants
* Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated
* Imaging evidence or other evidence that suggests the subject is not appropriate for mechanical thrombectomy intervention
* Life expectancy of \< 90 days
* Female who is pregnant or nursing
* Current participation in another investigational drug or device treatment study
A Registry of Patients Undergoing Cellvizio Endomicroscopy and Endoscopic Retrograde Cholangiopancreatography(ERCP) Imaging Procedures for Diagnosing Pancreatic and Bile Duct Cancers

This registry will collect data from patients routinely undergoing an ERCP and Cellvizio endomicroscopy procedure (and optionally an additional cholangiopancreatoscopy procedure) due to suspected pancreatic or bile duct cancer. The objective is to determine if endomicroscopy images collected using the marketed Cellvizio device may help endoscopists more accurately diagnose, in conjunction with traditional tissue sampling techniques, whether a suspected lesion is malignant or benign.

This is a registry study to collect high quality longitudinal data from patients with suspected or indeterminate pancreaticobiliary pathology who are undergoing an ERCP with Cellvizio probe-based endomicroscopy procedure, with or without supplemental direct cholangiopancreatoscopy. The hypothesis is that ERCP with Cellvizio probe-based endomicroscopy improves differentiation of biliary and pancreatic duct lesions versus ERCP alone.

Direct measures of accuracy (sensitivity, specificity, etc.) in the differentiation of malignant versus benign biliary and/or pancreatic duct lesions will be compared for the combination of endomicroscopy and ERCP imaging and ERCP alone. These presumptive diagnoses will be compared against a 12-month follow-up confirmed histopathologic endpoint (an initially-benign pathologic diagnosis will be confirmed by a 12-month follow-up). Secondary objectives include collecting various safety and technical performance parameters.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female \> 18 years of age
2. Willing and able to comply with Registry procedures and provide written informed consent to participate in the Registry
3. Indicated for ERCP and/or cholangiopancreatoscopy
4. Indeterminate or suspected biliary and/or pancreatic stricture, mass, or neoplasm

Exclusion Criteria:

1. Subjects for whom ERCP procedures are contraindicated
2. Known allergy to fluorescein dye