cyrilzakka/clinical-trials huggingface dataset:
Phase IV Interchangeability Study of a Liquid Pentavalent Combination Vaccine

The objective of this study is to compare the Safety and Immunogenicity of a mixed sequence of 2 different pentavalent vaccines (Diphtheria-Tetanus- Pertussis, Hepatitis B and Hib combination Vaccines) with single sequence of Shan 5 in infants.


Eligibility Criteria:
Inclusion Criteria:

* Healthy children in the age group six to eight weeks
* Born after a normal gestational period (36 - 42 weeks)
* Mother's HBsAg assured negative.
* Father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form.
* Parents willing to fill the Diary Card

Exclusion Criteria:

* Administration of immunoglobulin or any blood products since birth.
* Use of any investigational, on-registered drug, or vaccine other than the study vaccine (with the exception of OPV \& BCG vaccine) during the study period or within 30 days preceding the first dose of the study vaccine.
* Previous vaccination or evidence of infection with DTP or Hib.
* History of allergic disease or reaction likely to be exacerbated by any component of the vaccine including allergy to antibiotics.
* Major congenital or hereditary immunodeficiency.
* Infants having evidence of disease or fever, history of allergic disease or persistent hematological, hepatic, renal, cardiac or respiratory disease and signs of a CNS disorder at the time of vaccination.
* Infants showing any of the following reactions after any dose of study vaccine will be withdrawn for subsequent doses: body temperature more than 40.4 degree Celsius, persistent screaming or crying for 3 hours within 48 hours of vaccination, seizures, encephalopathy and hypersensitivity reaction.
* Parent/s or guardian of subject unable to maintain diary card
* Simultaneous participation in any other clinical study
Mechanisms of Exercise-induced Bronchospasm

The term exercise-induced bronchospasm (EIB) describes acute, transient airway narrowing that occurs during, and most often after, exercise. Manifestations of EIB can range from mild impairment of performance to severe bronchospasm and respiratory failure.

The pathogenesis of EIB remains controversial and the role of airway inflammation has not yet been definitively characterized. We plan on comparing markers of inflammation in asthmatic participants with and without EIB at baseline and after bronchoprovocation with eucapnic voluntary hyperventilation testing (EVH). We also will collect demographic information as well as information about asthma control and exercise habits.

At Visit 1, participants will complete questionnaires about demographics, asthma control (if asthmatic) and exercise habits. The participants will have baseline spirometry performed, and skin prick testing for allergies. Skin testing is important as it can influence the level of exhaled nitric oxide and hence we would like to adjust our results for the presence of allergies. Subsequently, volunteers will undergo sputum induction and then have peripheral blood drawn for microRNA analysis. MicroRNA's are single-stranded RNA molecules of about 21-23 nucleotides in length regulating gene expression. Patterns of MicroRNA expression have been linked to heart disease and cancer. Similar patterns have not been identified in exercise-induced asthma. In total, including time for questions and recovery, the time for Visit 1 will be approximately 3 hours.

At Visit 2, which will occur 24 hours to 7 days after Visit 1 in order to minimize risk of asthma exacerbation, the participants will again have baseline spirometry. Baseline exhaled nitric oxide will be performed. Eucapnic Voluntary hyperventilation testing will then be performed. They then will have a second exhaled nitric oxide quantification, will undergo sputum induction and then have peripheral blood drawn for microRNA analysis, all occurring after EVH testing. In total, including time for questions and recovery, the time for Visit 2 will be approximately 2 hours.

Eligibility Criteria:
Inclusion Criteria:

1. Men and women
2. History of physician-diagnosed asthma
3. Age between 18 and 70 years old.
4. Females of childbearing age may participate only if they have a negative pregnancy test, are non-lactating, and agree to practice an adequate birth control method (abstinence, combination barrier and spermicide, or hormonal) for the duration of the study. These requirements for contraception also apply to women who may have irregular or absent menstrual periods.
5. Non-smoker for 6 months or longer
6. Less than 10 pack year (number of packs per day (x) years of smoking = pack years) smoking history

Exclusion Criteria:

1. Objective evidence of severe lung impairment on pulmonary function testing performed at the beginning of the study.
2. Participation in another interventional research trial
3. Unable to provide consent
4. Pregnancy
5. Asthma exacerbation within the last 4 weeks.
6. History of severe reaction to allergy skin testing
Posturography as Biomarker of Oculomotor and Postural Control Integration

Determine the effects looking in certain direction or moving the eyes in a certain way have on the ability of a subject to maintain equilibrium in different circumstances (eyes open/closed, and standing on hard or compliant surface, with the head straight or rotated right or left, flexed or extended).

Subjects will undergo computerized dynamic posturography (CDP) testing using the extended modified Clinical Testing of Sensory Integration in Balance (ext_mCTSIB) protocol: the subjects will be required to stand on a hard or the compliant surface in a comfortable posture, feet shoulder width, with eyes open or closed, arms to the side and free to move, gazing forward, and breathing normally, with head straight, turned right or left, flexed or extended. This testing will be used to determine the health status of the subjects.

Then a sequence of tests will be performed (they could be done in different days to avoid fatiguing the subject): each sequence will comprise of a baseline test in one of the ext_mCTSIB testing conditions and a subsequent test in the same conditions but with an oculomotor additional task, such as gazing in a specific direction other than straight, performing saccades in different directions, at different speed and using different paradigms (prosaccades, antisaccades, to a remembered target, gap saccades, ...), following a target moving on the screen at different speed and in different directions, receiving an optokinetic stimulation in different directions and at different speeds. Video recordings of the eyes movement may be done to make sure that the subject is actually moving the eyes, to verify that the observers are well trained to detect and count the saccadic movements, as well as to obtain quantitative information regarding the eye movements per se.

Eligibility Criteria:
Inclusion Criteria:

* Self assessed healthy subjects

Exclusion Criteria:

* subjects suffering from pathology known to affect balance
Placement of Novel Endoscopic Enteral Feeding Tube

The aim of this study is to evaluate the technical feasibility of the new tube placement technology in healthy volunteers and, if proven feasible, in critically ill patients requiring placement of a feeding tube.

Enteral feeding is the preferred route of nutrient delivery in hospitalized patients who cannot eat sufficiently. Placement of enteral feeding tubes carries a risk of misplacement especially in patients who are unable to fully collaborate during the tube placement due to neurological impairment and/or the presence of an artificial airway. The misplacement of a feeding tube in the airways has a high risk of severe complications, including pneumonia, mechanical damage of airways and the lung, and death. The verification of correct tube placement can be done using radiography, or interventions aimed at confirming the location of the tube tip by aspiration of gastric contents, and by auscultation during injection of air.

Approximately 20-25 % of patients treated in intensive care units are likely to need placement of a feeding tube, while undergoing mechanical ventilation and having an artificial airway. This high risk patient group would benefit from technologies allowing direct visualization of tube placement. It is also expected that direct visualization of tube placement will allow confirmation of tube placement and therefore eliminate the need of radiography (radiation).

Eligibility Criteria:
Inclusion Criteria:

Healthy volunteers

* Informed Consent as documented by signature (Appendix Informed Consent Form)
* Age \>18 years

Patients

* Age \>18 years
* mechanically ventilated and requiring a placement of a postpyloric feeding tube on clinical indications
* Informed Consent as documented by signature of relatives

Exclusion Criteria:

Healthy volunteers and patients

* Unrepaired tracheoesophageal fistula
* history of prior esophageal or gastric surgery
* esophageal obstruction, stricture, varices or diverticulum
* esophageal or gastric perforation, gastric or esophageal bleeding
* recent oropharyngeal surgery
* cervical spine injury or anomaly

Additional exclusion criterion for patients only

• know severe coagulopathy (defined as thrombocyte count less than 30x10e9/l or International Normalized Ratio (INR) \> 3)
Study Evaluating SC262 in Subjects With r/r Non-Hodgkin's Lymphoma (VIVID)

SC262-101 is a Phase 1 study to evaluate SC262 safety and tolerability, anti-tumor activity, cellular kinetics, immunogenicity, and exploratory biomarkers.

This is an open-label, single arm, Phase 1, first-in-human (FIH) study to evaluate the safety and tolerability of SC262 administered intravenously (IV) following a standard lymphodepleting chemotherapy regimen of cyclophosphamide and fludarabine in subjects with Non Hodgkin's Lymphoma (NHL) who have received no more than 1 prior CD19-directed Chimeric Antigen Receptor T-Cells (CAR T) cell therapy. This study will be conducted in 2 parts. Dose finding using a 3+3 design in subjects with NHL. Dose expansion to further evaluate safety and efficacy at the recommended phase 2 dose (RP2D) in subjects with Large B-Cell Lymphoma (LBCL).

Eligibility Criteria:
Inclusion Criteria:

1. Male or Female Subject aged 18-80 years at the time of signing the informed consent
2. Histologic diagnosis of NHL (based on World Health Organization 2016 criteria) including:

   * LBCL, including Diffuse Large B Cell Lymphoma (DLBCL) not otherwise specified (NOS) (including DLBCL arising from indolent lymphoma), Primary Mediastinal Large B-Cell Lymphoma (PMBCL), High-Grade B-Cell Lymphoma (HGBCL), and Follicular Lymphoma (FL) Grade 3B
   * FL
   * Marginal Zone Lymphomas (MZL)
   * Mantle Cell Lymphoma (MCL)
3. Relapsed or refractory disease after no more than 1 prior CD19-directed CAR T cell therapy
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
5. At least 1 measurable (PET-positive) lesion per Lugano classification
6. Life expectancy ≥12 Weeks

Exclusion Criteria:

1. Prior CD22-directed therapy including CD22-directed CAR T cell therapy or other CD22 -directed antibody or cell therapy (e.g., Natural Killer (NK) cell)
2. History of central nervous system (CNS) involvement of lymphoma within 1 year prior to enrollment.
3. Autologous hematopoietic stem cell transplantation (HSCT) within 3 months before treatment with Lymphodepleting (LD) chemotherapy (or allogeneic HSCT at any time)
4. Active autoimmune disease or any other diseases requiring immunosuppressive therapy or corticosteroid therapy (defined as \>10 mg/day prednisone or equivalent)
5. History or presence of CNS disorder, such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement, within 12 months of enrollment.
Footwear Difference in Sports Use in Runners With Functional Equinus

Observational study on Nimbus shoes for daily training with 8mm drop and designed for heavier than normal weight. Shoe weight is 300g with highly structured buttress and upper with internal heat-sealed midfoot for greater lateral stability. This is a Novablast shoe with a mixed profile for training and competition with 8mm drp and higher midfoot compression range with less lateral containment.


Eligibility Criteria:
Inclusion Criteria:

* patients with functional equine
* regular runners

Exclusion Criteria:

* patients with severe heterometry (more than 1 cm).
* Recent lower limb interventions
Ursodeoxycholic Acid Attenuates Statin-Induced Impaired Glucose Tolerance

The purpose of this clinical trial is to understand whether the drug Ursodeoxycholic acid (UDCA) can prevent glucose intolerance in participants with hyperlipidemia who are taking statins. It will also assess the safety of UDCA. The primary questions it aims to answer are:

* Will UDCA reduce the incidence of glucose intolerance in participants taking oral statins?
* Will the use of UDCA decrease other adverse events in patients taking oral statins?

Participants will:

* Take Atorvastatin combined with UDCA or a placebo daily for 6 months
* Have follow-up visits on day 40, day 110, and day 180 Have their examination indicators recorded.


Eligibility Criteria:
Inclusion Criteria:

* Age 40-75 years old.
* LDL-C≥4.1mmol/l (160 mg/dL).
* Glycosylated hemoglobin \< 6.0% (39 mmol/mol).
* Voluntarily sign informed consent.

Exclusion Criteria:

* Previous diagnosis of diabetes or prediabetes.
* Past or current use of hypoglycemic drugs.
* Previous lipid-lowering treatment with lipid-lowering drugs or other means (such as traditional Chinese medicine or omega-3 fatty acids).
* Taking glucocorticoid drugs or using birth control drugs.
* Combined oral drug quantity ≥3.
* History of ASCVD (previous myocardial infarction, ACS, stroke or TIA within 1 year, symptomatic peripheral vascular disease).
* Active liver disease (defined as elevation of alanine aminotransferase (ALT), aspartate aminotransferase (AST) \> 3 × upper limit of normal (ULN) or total bilirubin \>2 × ULN from any existing known liver infectious, neoplastic, or metabolic pathologic cause or unknown cause at the time of screening), Severe hepatic insufficiency and biliary obstruction.
* Difficult to control hypertension: defined as systolic blood pressure ≥180mmHg or diastolic blood pressure ≥110mmHg despite antihypertensive therapy prior to randomization.
* Estimated glomerular filtration rate (eGFR) ≤ 30 mL/min/1.73m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) method
* New York Heart Association (NYHA) Class IV heart failure or a known left ventricular ejection fraction \< 25%
* A clinically significant and drug- or ablation-resistant arrhythmia within 3 months prior to randomization
* An acute or severe systemic infection, or any of the following diseases: hematological disorders, autoimmune disorders, malignant tumors, psychiatric patients, or other serious or unstable conditions that could impact study health status
* Scheduled for surgery within 6 months
* Pregnant, breastfeeding, or trying to become pregnant during the study or within 6 months of study completion
* Subjects with alcohol or other drug addiction
* Secondary hypercholesterolemia, such as hypothyroidism or nephrotic syndrome
* A history of allergic reaction to any study drug or its excipients or similar chemical classes of drugs
* A family history of homozygous familial hypercholesterolemia
* Participants currently enrolled in another clinical trial, who have withdrawn within the past month, or who cannot adhere to 6-month follow-up
* Any condition that the investigator considers unsuitable for participation.
Bio-Feedback to Improving Stability in Elderly Population

Our hypothesis is that intensive training with positive biofeedback may enhance postural control and stability in Parkinson's disease patients and in elderly fallers.

The aim of the study is to treat Parkinson's patients and elderly fallers. The intervention is intensive training with Biofeedback to try to correct stooped posture, and to improve stability in standing and in walking.

Eligibility Criteria:
Inclusion Criteria:

* Idiopathic PD for \>2 yrs
* Between 50-90 Yrs
* On anti-Parkinsonian medication
* Hoehn \& Yahr 2-3 in "ON"
* Free of serious co-morbidities
* Able to walk but reports difficulties in gait
* Can use assistive device

Exclusion Criteria:

* Significant orthopedic disturbances or pain
* Major depression (DSM IV)
* Dementia (MMSE\<24)
* Clinically significant hearing problems
* Unstable medical condition (2 wks from meds change)
* Deep Brain Stimulation
Evaluation of Effectiveness and Safety of Ultimaster™ Tansei™ Stent in Routine Clinical Practice

This study is to evaluate the effectiveness and safety of Ultimaster Tansei stent in the "real-world" daily practice.


Eligibility Criteria:
Inclusion Criteria:

1. Patients ≥ 19 years old
2. Patients receiving Ultimaster™ Tansei™ stents.
3. The patient or guardian agrees to the study protocol and the schedule of clinical follow-up and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site.

Exclusion Criteria:

1. Patients with a mixture of other drug-eluting stents (DESs)
2. Terminal illness with life-expectancy ≤1 year.
3. Patients with cardiogenic shock
Utility of Liver and Splenic Stiffness in Predicting Esophageal Varices in Patients With Acute on Chronic Liver Failure

Monitoring and Assessment: Transient Elastography will be performed in morning hours using the FibroScan apparatus (Echosens), which consists of a 5-MHz ultrasound transducer probe mounted on the axis of a vibrator. The tip of the transducer (M-or XL probe) will be covered with a drop of gel and placed perpendicularly in the intercostal space, with the patient lying in dorsal decubitus position with the right arm in the maximal abduction. Under control, in time motion and in A-mode, the operator will choose a liver portion within the right liver lobe, at least 6-cm thick and free of large vascular structures, and the gallbladder. Liver stiffness (LS) will be measured on a cylinder of hepatic tissue of 1 cm of diameter and 4 cm of length. For assessing the splenic stiffness (SS), the patient will be in supine position with left arm in maximum abduction. Ultrasonography will be used to identify and locate the spleen parenchyma, to choose the right place for SS measurement, and to measure the spleen diameter (long axis). Transducer will be placed in the left intercostal spaces, with location indicated by the ultrasound. A median value of 10 successful acquisitions, expressed in kPa, will be kept as a representative of the LS and SS measurements. The LS and SS measurement failure will be recorded when no value will be obtained after at least 10 shots. The results will be considered unreliable in the following circumstances: valid shots fewer than 10, success rate \< 60%, or interquartile range / LS \>30 %. Liver and splenic stiffness, LSPS score (LS measurement × spleen diameter / platelet count), Platelet count to spleen diameter ratio (PSR) will be calculated. Patient will also undergo upper g.i. endoscopy on same day. HVPG and TJLB will be done if indicated. The study will assess whether the stiffness scores correlate with presence of esophageal varices. Optimum cutoffs will be calculated for predicting the presence of esophageal varices.

* Study design: A Cross-Sectional Study
* Study period: 12 months
* Sample size with justification: Consecutive Patients of ACLF from approval of study to 12 months. ACLF patients will be screened and eligible patients will be taken in to the study.
* Intervention: Patients of ACLF will undergo upper g.i. endoscopy, liver and splenic stiffness measurement. HVPG and TJLB will be done in the patients only if clinically indicated.


Eligibility Criteria:
Inclusion Criteria:

- Patients of ACLF (APASL criteria).

Exclusion Criteria:

1. Age \< 18 and \> 70 years
2. moderate to severe ascites
3. Portal Vein Thrombosis
4. Hepatocellular carcinoma
5. space occupying lesion liver
6. heart failure
7. biliary obstruction
8. prior variceal endotherapy or ongoing beta blocker treatment for varices
9. pregnancy
10. ICD / pacemaker
11. ongoing treatment for HBV
12. HCV or ended within 3 months
13. No consent.
Eluna Family / Sentus BP Master Study

The Eluna Family / Sentus BP Master Study is designed to confirm the safety of the new Eluna pacemaker family and the Sentus BP (bipolar) left ventricular lead.

Furthermore the new wandless RF telemetry function "SafeSync" and the handling of the Sentus lead during implantation will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Patient is willing to participate in the study and provided written informed consent
* Patient meets standard indication for pacemaker or CRT-P or CRT-D therapy
* Patient accepts Home Monitoring® concept
* Patient has legal capacity and ability to consent

Exclusion Criteria:

* Patient with any contraindication to pacemaker and CRT-P and CRT-D therapy
* Patient under the age of 18
* Pregnant or breast-feeding women
* Cardiac surgery planned within the next 6 months
* Life expectancy less than 12 months
* Participation in another cardiac clinical investigation with active treatment arm
* Group B only: Currently implanted with an endocardial or epicardial LV lead or had prior attempt to place a LV lead (for CRT implants only)
Multiple Dose Effects of Hydrochlorothiazide and Isosorbide Mononitrate on Glucose Homeostasis (MK-0000-117)(Completed)

This study will measure and compare changes in insulin production and sensitivity using the hyperglycemic clamp technique in obese patients with impaired glucose tolerance and hypertension treated with placebo, isosorbide mononitrate (ISMN) or hydrochlorothiazide (HCTZ).


Eligibility Criteria:
Inclusion Criteria:

* Female participants must be post-menopausal
* Body Mass Index (BMI) of at least 29 kg/m\^2
* Weight has been stable over the past 3 months
* Has never been treated for hypertension or is diagnosed with hypertension taking up to 2 anti-hypertensive medications
* Willing to stop hypertension treatment for 14 days prior to randomization and throughout the study
* Does not have a history of diabetes
* In good health with the exception of hypertension
* No history of abnormal heart rhythms
* Part I only: willing to comply with high potassium/low sodium diet for the duration of the study
* Willing to avoid strenuous physical activity during the study
* Nonsmoker and/or has not used nicotine for at least 3 months and agrees to refrain from use of tobacco-containing products throughout the study
* Agrees to refrain from consuming alcohol and caffeine during in-patient periods and to limit consumption at all other times during the study
* Agrees not to consume grapefruit, grapefruit products, and citrus, apple, and pineapple juices 2 weeks prior to administration of the first dose of study drug

Exclusion Criteria:

* History of any illness that may make their participation in the study unsafe or confuse the study results
* Taking spironolactone or eplerenone
* Cannot refrain from using any prescription or non-prescription drugs during the study
* On a weight loss program and is not in the maintenance phase
* Started a weight loss drug within 8 weeks of the first study visit
* Consumes excessive amounts of alcohol or caffeine
* Has had major surgery, donated or lost 1 unit of blood within 4 weeks of the first study visit
* History of multiple and/or severe allergies to drugs or food
* Is dehydrated