cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate Persistence of Immune Responses After Post-exposure Prophylaxis of Rabipur® (Purified Chicken-embryo Cell Rabies Vaccine) in Chinese Children

The purpose of this study is to evaluate the long-term persistence of immune responses approximately 5 years or more after simulated rabies post-exposure prophylaxis provided in 2012 according to Essen (1-1-1-1-1) or Zagreb (2-1-1) intramuscular (IM) regimens in the subset of subjects who participated in the parent study (V49_24 \[NCT01680016\]) who were aged ≥6 and ≤17 years at the time of enrollment.

This study is aimed to respond to a post-marketing commitment by the China Food and Drug Administration (CFDA) requested at the time of the renewal of the purified chicken-embryo cell rabies vaccine license in China, granted in August 2015.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects with age ≥ 6 and ≤17 at the time of enrollment in the parent study who signed the informed consent prior to the extension study entry, who received the full PEP in the parent study according to either the Zagreb or Essen intramuscular regimens.
2. Subjects who or whose parent(s)/legal guardian(s) have voluntarily given written informed consent/assent for this extension study after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
3. Individuals who can comply with study procedures.

Exclusion Criteria:

Prior to extension study entry, each subject must not have:

1. Documented medical history of exposure to rabies or rabies prophylaxis after completion of the parent study (V49_24 \[NCT01680016\]) and before study start.
2. Participated in the parent study (V49_24 \[NCT01680016\]) but not received the full PEP vaccination course (or received it out of window) following assignment to either Zagreb or Essen regimen during the parent study.
3. Progressive, unstable or uncontrolled clinical conditions.
4. Clinical conditions representing a contraindication to blood draws.
5. Abnormal function of the immune system resulting from:

   1. Clinical conditions.
   2. Systemic administration of corticosteroids for more than 14 consecutive days within 90 days prior to informed consent for all age groups.
   3. Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent for all age groups.
6. Received immunoglobulins or any blood products within 180 days prior to informed consent for all age groups.
7. Study personnel as an immediate family or household member.
8. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study.
Early Mobilization of Ischemic Stroke Patients Within 24-hours After Intravenous-Tissue Plasminogen Activator (IV-tPA)

The purpose of this study is to study the safety and feasibility of mobilization of acute ischemic stroke patients treated with IV-tPA between 12-24 hours of treatment.

Abstract:

Introduction

Historical precedence exists demonstrating that early intensive care unit (ICU) mobilization of patients reduces risks of complication and lengths of hospital stay, and may improve long-term health status of patients.

Objective

To determine the safety of early mobilization by physical and/or occupational therapy in acute ischemic stroke patients within 24-hours of IV-tPA infusion and to examine if early mobilization leads to shortened ICU and hospital length of stay.

Methods

Prospective study of incidence of adverse response and functional mobility status of study patients mobilized by occupational and/or physical therapy between 12- 24 hours after IV-tPA infusion with comparison of ICU and hospital Length of Stay data between study group and pre-study patients who were mobilized by occupational and/or physical therapy services at no pre-determined time after IV-tPA infusion. Additionally, patients will be contacted by study personnel approximately 3 to 5-days and 30-days post-infusion for completion of Modified Rankin Scale stroke disability survey as follow up of stroke recovery.

Setting

Medical and surgical intensive care units at Mayo Clinic Florida.

Patients

All patients with acute ischemic stroke who receive intravenous tissue plasminogen activator (IV-tPA) infusion, survive to discharge from the hospital, are hemodynamically stable, and are mobilized by physical and/or occupational therapy within 24 hours post-tPA infusion.

Eligibility Criteria:
Inclusion Criteria:

* Patients post acute ischemic stroke that have been treated with intravenous tissue plasminogen activator (IV-tPA)
* 13 hours have elapsed since initiation of intravenous TPA infusion
* Patients are hemodynamically stable (e.g., not on vasopressors or antihypertensive drips or requiring multiple IV PRN boluses of either medication)
* Patient is able to actively engage in the evaluation

Exclusion Criteria:

* Patients with femoral sheaths or recent removal of femoral sheaths
* Patients who are hemodynamically unstable, with active bleeding from lines, catheters, INT site or wounds or angioedema
* Electrocardiogram showing (HR\>100)
* Vital signs (HR \> 100, SBP \<90 or \>180, DBP \<70 or \> 105)
* Patients experiencing marked diaphoresis, facial pallor, intense anxious or painful facial expression (especially in aphasic patients)
Relative Bioavailability and Tolerability of Two New Different Extended Release Capsules of BIBV 308 SE, Versus a Solution of BIBV 308 SE in Healthy Subjects

Comparative pharmacokinetics and tolerability of two experimental extended release formulations and a standard formulation of BIBV 308 SE following multiple doses.


Eligibility Criteria:
Inclusion Criteria:

* Subjects that were previously entered in at least one BIBV 308 SE study to ensure that it is known how these subjects absorb BIBV 308 SE
* Healthy subjects as determined by results of screening
* Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
* Age \>= 18 and \<= 55 years
* Broca \>= -20% and \<= +20 %

Exclusion Criteria:

* Poor individual absorption kinetics of BIBV 308 SE in previous studies
* Any findings of the medical examination (including blood pressure, pulse rate and Electrocardiogram (ECG)) deviating from normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal (including thyroid) disorders
* Surgery of the gastro-intestinal tract (except appendectomy)
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
* Chronic or acute relevant infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Hypersensitivity to BIBV 308 SE and any of the excipients
* Intake of drugs with a long half-life (\> 24 hours) \<= 1 month prior to administration or during the trial
* Use of any drugs which might influence the results of the trial \<= 10 days prior to administration or during the trial
* Participation in another trial with an investigational drug \<= 2 months days prior to administration or during the trial
* Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
* Inability to refrain from smoking during the period of the study
* Known alcohol (\> 60 g/day) or drug abuse
* Blood donation (\<= 1 month prior to administration)
* Excessive physical activities (\<= 5 days prior to administration)
* Any laboratory value outside the normal range of clinical relevance
* History of haemorrhagic diathesis
* History of gastro-intestinal ulcer, perforation or bleeding
* History of bronchial asthma
Nipple Aspiration, Ductal Lavage, and Duct Endoscopy in Screening Women at Moderate-to-High Risk of Developing Breast Cancer

RATIONALE: Screening tests, such as nipple aspiration, ductal lavage, and breast duct endoscopy, may help doctors detect cancer cells early and plan more effective treatment for breast cancer.

PURPOSE: This clinical trial is studying how well nipple aspiration, ductal lavage, and breast duct endoscopy work in detecting cancer cells in healthy women who are at moderate-to-high risk of developing breast cancer.

OBJECTIVES:

Primary

* Determine the incidence of mild or severe cellular atypia in nipple aspirate fluid of healthy women at moderate to high risk of developing breast cancer, defined by family history or prior atypical biopsy.

Secondary

* Correlate cellular atypia with breast cancer, biochemical tumor markers, growth factors, and genetic and protein markers in these participants.
* Determine cancer risk and incidence utilizing these methods of screening in these participants.
* Observe the natural history of atypia in these participants over a total of 10 years.
* Determine whether these techniques may serve as supplementary tools in future screening of these participants.

OUTLINE: Participants under 50 years of age undergo nipple aspiration every twelve months for 3 years. Participants over 50 years of age undergo nipple aspiration every 18 months for 4.5 years.

Participants with significant cellular atypia in nipple aspirate fluid undergo ductal lavage and endoscopy.

Participants are followed annually for a total of 10 years.

PROJECTED ACCRUAL: A total of 1,000 participants will be accrued for this study within approximately 4 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Significant family history or prior atypical biopsy indicative of a moderate or high risk of developing breast cancer
* No concurrent inflammatory breast cancer
* Hormone receptor status:

  * Not specified

PATIENT CHARACTERISTICS:

Age

* 18 to 64

Sex

* Female

Menopausal Status

* Premenopausal or postmenopausal

Performance status

* Not specified

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

Other

* No prior allergy to EMLA cream or lidocaine
* No severe illness that would preclude study participation
* No mental illness or handicap that would preclude study compliance
* No concurrent active infection or inflammation in the breast being studied
* Not unconscious
* Not pregnant
* No nursing within the past 12 months

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* No prior subareolar surgery (e.g., microdochectomy or major duct excision) that may disrupt the ductal systems within 2 cm of the nipple
* No prior breast implantation on proposed lavage side
Biological Standardization of Poa Pratensis Allergen Extract

The objective of this study is to determine the biologic activity of a Poa pratensis allergen extract in histamine equivalent prick (HEP) units, in order to be used as in-house reference preparation (IHRP).

This is an open, unblinded and non-randomized biological assay. The study design is a slight modification of the recommendations proposed by the Nordic Guidelines.

Four concentrations of Poa pratensis allergen extract, together with a positive and negative control, using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol saline solution, respectively, will be tested in every patient in duplicate on the volar surface of the forearm.

Eligibility Criteria:
Inclusion Criteria:

1. A documented positive case history with inhalation allergy (rhinitis and/or rhinoconjunctivitis and/or asthma) related to Poa pratensis.
2. Subject has provided written informed consent, appropriately signed and dated by the subject (or legal representative, if applicable).
3. Subject can be male or female of any race and ethnic group.
4. Age \> 18 years and \< 50 years at the study inclusion day.
5. Positive skin prick test with a standardized commercially available preparation of Poa pratensis allergen extract. The skin prick test will be considered positive if the test results in a wheal major diameter of at least 3 mm and at least the size of the positive control. Positive skin prick test results are valid if performed within one year prior to the inclusion of the subject in the study
6. A positive test for specific IgE to Poa pratensis(CAP-RAST ≥ 2). IgE results are valid if performed within one year prior to the inclusion of the subject in the study.
7. Allergic symptoms during the pollen season of Poa pratensis.
8. Mean of the forearm major diameters of the wheals provoked by histamine dihydrochloride (10 mg/ml) ≥ 3 mm.

Exclusion Criteria:

1. Immunotherapy in the past 5 years with an allergen preparation known to interfere with the allergen to be tested (e.g., grass group extracts).
2. Use of drugs that may interfere with the skin reactions (e.g., antihistamines). See Appendix 1
3. Treatment with any of the following medications: tricyclic or tetracyclic antidepressants, β-blockers or corticosteroids (\> 10 mg/day of prednisone or equivalent).
4. Pregnancy.
5. Dermographism affecting the skin area at the test site at either study visit.
6. Atopic dermatitis affecting the skin area at the test site at either study visit.
7. Urticaria affecting the skin area at the test site at either study visit.
8. Participation in another clinical trial within the last month.
9. Subjects suffering from pathologies or conditions in which adrenalin is contraindicated (heart disease, severe hypertension,...)
Effects of Individual Intervention for Men in Focused Deterrence Program

This project will implement and evaluate a community-based intervention to improve individual outcomes in violence-related injuries and homicide. Young African American men participating in a focused deterrence program (the Birmingham Violence Reduction Initiative, BVRI) will be randomized to receive an additional individual intervention based on the cognitive-behavioral Reasoning and Rehabilitation program.


Eligibility Criteria:
Inclusion Criteria:

* African American male identified as at high risk for violence by the Birmingham Violence Reduction Initiative

Exclusion Criteria:

* Mental retardation, serious mental illness (eg, psychosis)
Garadacimab Safety, Pharmacokinetics, and Pharmacodynamics in Idiopathic Pulmonary Fibrosis

This is a prospective, phase 2a, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to assess the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of garadacimab in subjects with idiopathic pulmonary fibrosis (IPF).


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients ≥ 40 years of age
* Documented diagnosis of IPF

Exclusion Criteria:

* History of clinically significant cardiovascular disease, including myocardial infarction, unstable ischemic heart disease, congestive heart failure, or angina during the 6 months before screening
* Sinoatrial or atrioventricular block, uncontrolled hypertension
* Active bleeding or current clinically significant coagulopathy
A Trial of Point of Care Information in Ambulatory Pediatrics

Does presentation of clinical evidence for decision making at point-of-care improve prescribing patterns in ambulatory pediatrics?

We showed previously that an electronic prescription writer and decision support system improved pediatric prescribing behavior for otitis media in an academic clinic setting. This study assessed whether point-of-care evidence delivery could demonstrate similar effects for a wide range of other common pediatric conditions. We performed a randomized controlled trial in a teaching clinic/clinical practice site and a primary care pediatric clinic serving a rural and semi-urban patient mix. There were 36 providers at the teaching clinic/practice site, and 8 providers at the private primary pediatric clinic, and an evidence-based message system presented real time evidence to providers based on prescribing practices for acute otitis media, allergic rhinitis, sinusitis, constipation, pharyngitis, croup, urticaria, and bronchiolitis. We measured the proportion of prescriptions dispensed in accordance with evidence.

Eligibility Criteria:
Inclusion Criteria: The 44 clinical providers at the two participating clinics. -

Exclusion Criteria: Study investigators

-
The Effect of Statin Treatment on Arterial Wall Inflammation as Assessed With 68Ga-DOTATATE PET-CT

To study the effect of atorvastatin treatment on vascular uptake of 68Ga-DOTATATE in patients with Type 2 Diabetes.

Well controlled patients with type 2 diabetes, who are statin naïve, will undergo atorvastatin treatment. Before and after treatment, patients will undergo a 68Ga-DOTATATE PET/CT, to evaluate the effect of treatment on vascular inflammation.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 50 years and older
2. Diagnosed with diabetes mellitus type 2 and using oral glucose lowering therapy, insulin or combined glucose lowering therapy.
3. Not on statin therapy or willing to stop with current statin therapy for 6 weeks prior to visit 2.
4. HbA1c values below 65 mmol/L.
5. Patients with "stable" diabetes mellitus, i.e. no changes in type of glucose lowering therapy and / or dosage of oral glucose lowering therapy in the past three months. No more than 20% change in dosage of insulin therapy (short and long acting) in the last three months.

Exclusion Criteria:

1. History of cardiovascular disease (previous CV-event (MI / stroke) or known coronary artery disease (including acute coronary syndrome).
2. History of chronic kidney disease stage 3b - 5, defined as a CKD-EPI value of \< 45 ml/min/1,73m2
3. Malignant diseases or any clinically significant medical condition that could interfere with the conduct of the study in the opinion of the investigator.
4. Chronic or recent (\< 1 month) infections and/or clinical signs of acute infection.
5. History of auto-immune diseases.
6. Standard contra-indications to 68Ga-Dotatate PET, and CT based on physicians experience and current practices.
7. Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study.
8. Planned radiation exposure in the next year due to participation in a research project with radiation exposure or for clinical reasons.
9. Elevated liver enzymes (\> 2 ULN of liver transaminases), acute liver failure or known liver disease.
10. Prior medium to severe statin-related side effects or statin related hypersensitivity, i.e.

    (severe) muscle pains with and/or without myopathy .
11. The concomitant use of statin contra-indicated drugs, including the use of CYP3A4 inhibitors (i.e. erytromycin, dilthiazem, amiodaron, verapamil, fluconazole, ciclosporin, stiripentol, itraconazol, ketoconazol, voriconazol, posaconazol, clarithromycin, ..), systemic use of fusidic acid and ciclosporin.
12. Any contra-indications to the use of statins.
Evaluating Sublingual Dexmedetomidine For Moderate To Severe Agitation In Inpatients With Schizophrenia Or Bipolar Disorder

An open-label, randomized, active control inpatient trial to evaluate the efficacy and tolerability of sublingual dexmedetomidine for the treatment of agitation in inpatients with schizophrenia or bipolar disorder as measured by the Positive and Negative Syndrome Scale - Excited Component (PANSS-EC) and Agitation-Calmness Evaluation Scale (ACES). Lorazepam will serve as the active control.

This is an open-label, randomized control trial where patients (N=32) with schizophrenia or bipolar disorder are randomized to receive either sublingual dexmedetomidine or oral lorazepam monotherapy for the treatment of episodic agitation. For moderate agitation (PANSS-EC score ≥14 and \<20), patients will receive either sublingual dexmedetomidine 120mcg or oral lorazepam 2mg. For severe agitation (PANSS-EC ≥20), patients will receive either sublingual dexmedetomidine 180mcg or oral lorazepam 2mg. The PANSS-EC and ACES will be evaluated at baseline and after 15, 30, 60, and 120 minutes.

Eligibility Criteria:
Inclusion Criteria:

* The participant is an adult between the ages of 18-55 at the time of study participation
* Hospitalized on an inpatient unit at Episcopal Hospital
* Meet the DSM-5 criteria for schizophrenia, schizoaffective disorder, or bipolar disorder, as determined by routine clinical assessment conducted upon admission.
* Are able to understand and read English
* Are able to provide informed consent
* Experiencing a moderate (PANSS-EC score ≥14 and \<20) or severe (PANSS-EC score ≥20) episode of agitation

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* Prisoners
* Participant has an allergy to dexmedetomidine or lorazepam
* Participant has mild, moderate or severe hepatic impairment
* Participant has active pulmonary disease and is receiving treatment (oxygen, inhalers)
* Individual is currently prescribed scheduled benzodiazepines or methadone
* Participant history of QTc ≥ 500 msec or a history of arrythmia
* Participant recent (within the last 2 days) fall, syncope (passing out), feeling lightheaded, or pulse \<50.
* Individual has a history of hypokalemia or hypomagnesemia within the past 2 years?
* Participant is receiving high-risk medications, including:

  1. Methadone
  2. Midazolam
  3. Opioids
  4. High risk medications associated with the QT interval prolongation (sertindole, chlorpromazine, ziprasidone), (amiodarone, iboga, quinine, arsenic, ibutilide, selpercatinib, ivosidenib, bedaquiline, lenvatinib, sotalol, levoketoconazole, cisapride, vendetanib, mobocertinib, disopyramide, papaverine)
Arthroscopic Wafer and Ulnar Shortening in Ulnar Abutment

there are many management options of ulnocarpal abutment depends on clinical evaluation and imaging of this joint. Arthroscopic treatment is the simplest solution for these conditions.


Eligibility Criteria:
Inclusion Criteria:

* obvious ulnar abutment syndrome with ulnar side wrist pain

Exclusion Criteria:

* ulnar minus or neutral variance
* central and radial wrist pain
* osteoarthritis of the wrist.
Assessment of Circulatory Compromise With Ox-Imager Using a Vascular Occlusion Test Protocol

The objective of this study is to evaluate the performance of Modulated Imaging Inc.'s (MI) next generation Spatial Frequency Domain Imaging (SFDI) system to measure potential circulatory compromise.

The objective of this study is to demonstrate the performance of Modulated Imaging Inc.'s (MI) next generation Spatial Frequency Domain Imaging (SFDI) system, "The Ox-Imager Mini". Potential circulatory compromise will be imaged in healthy volunteers using both the subject and predicate devices (Ox-Imager CS) in a Vascular Occlusion Test (VOT) model. The VOT model is an established paradigm to introduce transient ischemia in skin and the the subjects will be imaged during this time. The primary endpoint will be to measure significant decrease in tissue oxygen saturation after occlusion for both predicate and subject devices.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age

Exclusion Criteria:

* History of congestive heart failure
* Patients with existing wound or ulcer.
* Rheumatoid arthritis
* Pregnant or lactating women
SHARE: Simple HAART With Abacavir, Reyataz, and Epivir

SHARE: Simple HAART with Abacavir, Reyataz, and Epivir

Open-label, multicenter study of ABC/3TC + ATV in subjects who have completed at least 24 weeks of treatment on ABC/3TC+ATV/RTV as their first line regimen and have plasma HIV-1 RNA \<50 copies/mL at entry

Eligibility Criteria:
Inclusion Criteria:

* Currently taking abacavir/lamivudine (Epzicom) in combination with atazanavir (Reyataz) boosted with ritonavir (Norvir) as first antiretroviral regimen
* Viral load \<50 copies/ml

Exclusion Criteria:

* Viral load \>50 copies/ml
* Having taken more than one antiretroviral regimen