cyrilzakka/clinical-trials huggingface dataset:
Bioequivalence Study of Cephalexin Suspension 125

The objective of this study was to confirm if two formulations of cephalexin suspension are bioequivalent.

Test product was Ceporex® (125 mg Cephalexin / 5 ml; GlaxoSmithKline) and reference product Keflex® (125 mg Cephalexin / 5 ml; Eli Lilly). The single dosage was 20 ml of suspension.

The study was prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods, under fasting conditions.

The population was composed of 28 healthy volunteers, both genders, adults between 18-50 years.

The comparative bioavailability of the two formulations was evaluated based in statistical comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations in blood.


Eligibility Criteria:
Inclusion Criteria:

Free will participation according to Mexican regulation, Helsinki Declaration, and Good Clinical Practice.

Healthy, between 18 and 50 years. Body Mass Index between 18 and 27.5 In good health by complete medical history and laboratory tests. Blood pressure 130-90/ 90-60 mm Hg; heart rate 55-100 beat per minute, respiratory rate 14-20 movements per minute.

Laboratory tests +/- 10% of normal interval (blood cytology, blood chemistry 27 elements, Hepatitis B and C antigens, HIV, urinalysis, anti-doping, pregnancy, electrocardiogram) -

Exclusion Criteria:

Alteration of vital signs Not complying with inclusion criteria History of cardiovascular, kidney, hepatic, muscular, metabolic, gastrointestinal (including constipation), neurologic, endocrine, hematopoietic (any kind of anemia), asthma, mental or organic disease. Those suffering from muscular trauma 21 days before the beginning of the study.

Requirement of any kind of medication during the course of the study, except study medication.

History of dyspepsia, gastritis, esophagitis, duodenal or gastric ulcer. Exposure to medications known as inducers or inhibitors of hepatic enzymes or administration of potentially toxic medication in the 30 days before the study beginning.

Administration of any medication in the 7 half-lives previous to the beginning of the study.

Hospitalization for any cause in the two months before the beginning of the study.

Administration of investigational drugs in the 60 days before the study. Allergy to any medication, food or substance. Alcohol ingestion or intake of beverages containing xanthines (coffee, tea, cocoa, chocolate, mate, cola drinks) or ingestion of charcoal grilled food or grapefruit or orange juice in the 72 hours before the hospitalization or tobacco smoking in the 72 hours before the beginning of the study.

Blood donation or loss =\> 450 ml in the 60 days before the beginning of the study.

History of drug or alcohol abuse. Special diet requirement, for instance vegetarian diet. Inability to understand nature, aims, and possible consequences of the study. Evidence of non-cooperative attitude during the study. Positive antidoping or pregnancy test Breast-feeding. Females on hormonal treatment.

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Randomized Study on Postmenopausal Women With Early Stage Breast Cancer: WBI Versus APBI

Selected patients with early stage breast cancer undergone conservative surgery were randomized in two arms: Hypofractionated Whole Breast Irradiation versus Accelerated Partial Breast Irradiation.

Patients treated with Hypofractionated Whole Breast Irradiation (WBI) received SIB irradiation of the whole breast and surgical bed at two different dose levels. Dose prescription was 40.5 Gy to PTVWB and 48.0 Gy to PTVboost in 15 fractions over 3 weeks, with simultaneous integrated boost delivering 2.7 and 3.2Gy/fraction for each PTV respectively. Daily image guided radiotherapy (IGRT) were generated before each treatment session in each patient to verify the set-up.

Accelerated Partial Breast Irradiation (APBI) using external intensity -modulated radiotherapy (VMAT RA) was delivered at a dose of 30 Gy in five 6-Gy/day fractions over 10 days (every other day) with IGRT at each treatment.

Eligibility Criteria:
Inclusion Criteria:

* 55\< Age \<70
* Tumor size ≤ 2 cm
* pN0 (SN biopsy or ALND)
* ER/PgR positive
* Margins \> 5 mm (either at initial surgery or at re-excision)
* Clips placed in the surgical bed (minimum of 4 clips)
* Unicentric only
* No lymphovascular invasion
* Any grade
* No extensive intraductal component (\>25%)
* Written informed consent

Exclusion Criteria:

* Prior thoracic radiation therapy
* Oncoplastic surgery / No clips in the surgical bed
* Multicentric cancer
* Autoimmune disease, vasculitis, collagenopathy or scleroderma that may predispose to late sequelae
Assess Itch Behavior in Nickel Sulphate Sensitized Volunteers

Determine the mean time to itch relief from the start of treatment with topic methylprednisolone aceponate.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects ≥18 years old.
2. Subjects with a history of diagnosis of sensitization to Nickel sulphate.
3. Delayed type hypersensitivity demonstrated by positive reaction with epicutaneous or patch test.
4. Skin Phototype II-III.
5. Women with fertile age and a negative result in the pregnancy test before inclusion. Women must use an adequate contraceptive method during the study.
6. Written informed consent prior to inclusion.
7. Able and willing to comply with protocol procedures and to follow the investigator's instructions.

Criteria for treatment initiation: At day 7, before starting treatment, subjects must meet the inclusion criteria and all the following criteria: ≥ 3 VAS and eczema intensity of (+ +) or (+++) according to ICDRG scale.

Exclusion Criteria:

1. Active cutaneous disease causing itch (active eczema, urticaria or insect bites)
2. Active systemic disease that may induce itch (hepatic or renal disease).
3. Active psychiatric disease that could interfere with symptom assessment.
4. Treatment with drugs inducing itch.
5. Treatment with oral or topical preparations that could interfere with the itching sensation induced by patch test.
6. Treatment with systemic or topical corticosteroids, antihistaminics or calcineurin inhibitors.
7. Active skin disease in the back that may interfere with the assessment of response to topical application of allergen
8. Pregnancy or lactation
9. Subjects with contraindications specified in Summary of Product Characteristics (SPC).
Post-Authorization Observational Study to Evaluate Cognition and Fatigue in Relapsing-remitting Multiple Sclerosis (RRMS) Patients Treated With Rebif®

The study is planned to evaluate the cognitive functions in subjects with RRMS treated with interferon beta-1a, and its relationship to the fatigue and neurological dysfunction status.

Besides the motor and sensory dysfunctions, the progression of cognitive decline is a frequent manifestation of RRMS. Fatigue is another important symptom of MS, and can negatively affect subject's Quality of life (QoL) and socio-economic functioning, including the ability to work, independent of the direct effects of disability. This is a phase IV observational, non-interventional, prospective, multicentric study to evaluate cognition in RRMS subjects treated with Rebif and its relationship to the fatigue and neurological dysfunction status. The study plans to enroll 300 subjects, across 14 centres in Czech Republic, who will be prescribed with Rebif according to its summary of product characteristics (SmPC). Assessment of cognitive and fatigue status will be done at baseline and follow-up visits at Months 3, 6, 12, 24. Subjects will be selected using the convenience method following the non-probability sampling.

OBJECTIVES

Primary Objective:

* To assess changes of cognition \[measured by Paced Auditory Serial Addition Test (PASAT)\] in RRMS subjects treated with Rebif

Secondary Objectives:

* To assess changes of fatigue \[measured by Fatigue Descriptive Scale (FDS)\] in RRMS subjects treated with Rebif
* To assess a correlation between cognition, fatigue and neurological status in RRMS subjects treated with Rebif
* To assess a relationship between Rebif dosage \[22 mcg vs 44 mcg thrice a week (tiw)\] and cognition (PASAT)
* To assess a relationship between Rebif dosage (22 mcg vs 44 mcg tiw) and fatigue (FDS)
* To assess adherence to Rebif treatment
* To explore the use of antidepressive and antifatigue medicaments

Eligibility Criteria:
Inclusion Criteria:

* Subjects diagnosed with RRMS
* Subjects eligible for treatment with Rebif as per SmPC, the Czech local guidelines and the actual Health insurance policy.
* Subjects 18-65 years of age
* Subjects with EDSS score \< 4
* Subjects who are willing and able to give informed consent

Exclusion Criteria:

* Treatment with Rebif for more than 24 months prior the informed consent form has been obtained.
* Subjects with history of hypersensitivity to natural or recombinant interferon-β, or to any excipients
* Female subject who is pregnant or breast feeding and/or planning to become pregnant
* Subjects with current severe depression and/or suicidal ideation
* Any contraindication for Rebif therapy as per SmPC
* Subjects with severe disability and/or any neurologic or psychiatric condition that may interfere with test performance
* Prior treatment with interferon beta-1a i.m. or interferon beta-1b or glatiramer acetate.
A Drug-Drug Interaction Study of ALKS 5461 in Healthy Volunteers

This study will evaluate the impact of Itraconazole on the pharmacokinetics of ALKS 5461.


Eligibility Criteria:
Inclusion Criteria:

* Has a body mass index (BMI) of 18.0 - 30.0 kg/m2
* Is in good physical health
* Agrees to use an approved method of contraception for the duration of the study
* Additional criteria may apply

Exclusion Criteria:

* Has current evidence, or history of any clinically significant medical or psychiatric condition or observed abnormality
* Is currently pregnant or breastfeeding
* Has a history of or current infection with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus (HIV)
* Has a lifetime history of opioid abuse or dependence
* Has current abuse or dependence on alcohol or any drugs
* Has used nicotine within 90 days prior to randomization
* Additional criteria may apply
Neural Mechanisms in Asthma

Asthma is a chronic disease that affects nearly 13% of adults in the U.S., causing substantial impairment that is reflected in the tens of millions of missed days of work, and doctors' and emergency room visits it leads to annually. Those who have asthma are twice as likely to develop depression and anxiety, which are associated with more frequent and severe asthma symptoms, especially in those under chronic stress. The project proposed here seeks to understand the role of the brain in these associations and to evaluate the neural mechanisms through which a safe, low-cost intervention, that influences the function of body via the mind, may diminish the expression of asthma symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Asthmatics:

  * Physician diagnosed asthma with previous use of asthma medication
* Controls:

  * negative skin-prick test to cat dander or house dust mite and have no history of asthma
* Chronic Stress:

  * score 3 or above on any subscale of the UCLA (University of California Los Angeles) chronic stress interview

No chronic stress:

score 1.5 or below on all subscales of the UCLA chronic stress interview

Exclusion Criteria:

* Individuals with severe asthma, or those whom currently require the use of corticosteroids
* Individuals with significant medical problems
* Individuals who smoke cigarettes
* Individuals a previous adverse reaction to corticosteroids, a recent (\< 1 month) viral illness, a history of severe asthma or anaphylaxis.
* Breastfeeding women or women who are, suspect they might be or are trying to become pregnant
Analgesic Efficacy of Ultrasound-guided Bilateral Pecto-intercostal Plane Block in Pediatric Cardiac Surgery

The goal of this study is to compare patients outcome in two groups. the first group will be applied pecto-intercostal fascial block additional to general anesthesia and the second group will not.

This is a single-center, prospective, observational trial to study the efficacy of Pecto-intercostal Fascial Block (PIFB) in patients undergoing pediatric congenital cardiac surgery requiring median sternotomy and cardiopulmonary bypass. The children are aged between 6 months to 12 years with American Society of Anesthesiologists (ASA) score 2 or 3.

The main question it aims to answer are:

The investigators' first question is if applying pecto-intercostal fascial block just after anesthesia induction reduces postoperative pain status. Secondly, if this pain status makes any reduction in preoperative opioid consumption. The investigators aim to find out; if there is any difference in opioid consumption during operation and postoperative 24-hour, postoperative Face, Legs, Activity, Cry, Consolability (FLACC) scale, length of intensive care unit and hospital stays, and other complications.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing pediatric congenital cardiac surgery requiring median sternotomy and cardiopulmonary bypass.
* age between 6 months and 12 years
* ASA score 2 or 3
* Risk Adjustment for Congenital Heart Surgery (RACHS-1) score under 4

Exclusion Criteria:

* patients who need mechanical ventilation support before surgery
* patients who need to stay intubated more than 24 hours after surgery
* patients undergo complex cardiac surgery with RACHS-1 score higher than 4.
* patients without consent
* having allergic reaction to bupivacaine
* having cardiac surgery before (redo patient)
Difficult Cannulation Criteria in Trainee Involved ERCP Cannulation

Endoscopic Retrograde Cholangiopancreatography (ERCP) is one of the most technically challenging procedures in gastrointestinal endoscopy. Selective deep cannulation is a critical step for the performance of ERCP. The incidence of difficult cannulation has been reported in many studies, ranging from 10% to 40% in patients with native papilla. Difficult cannulation is an independent risk factor for post-ERCP pancreatitis (PEP).

The definition of difficult cannulation has been proposed by European Society of Gastrointestinal Endoscopy (ESGE) guidelines. Initial cannulation is considered difficult with the presence of one or more of the following: more than 5 min for attempting to cannulate; more than 5 contacts with the papilla; more than 1 unintended pancreatic duct cannulation or opacification. The clear definition of difficult cannulation is important for making decisions during or after ERCP, including determining the appropriate time to transfer to advanced cannulation techniques (e.g. early precut) and whether prophylactic methods should be administrated to reduce the risk of PEP. Although 5-5-1 criteria have been widely used during ERCP practice or in relevant studies, it remains unclear whether the current criteria are suitable for the cannulation procedure with trainee involvement. Because of inexperienced manipulation of the scope and accessories, the involvement of trainees generally increases the overall cannulation time and attempts, which are the two important parameters in the criteria of difficult cannulation. Thus, the investigators hypothesized that the definition of difficult cannulation in trainee-involved cannulation might be different from the traditional 5-5-1 criteria.


Eligibility Criteria:
Inclusion Criteria:

* patients with native papilla

Exclusion Criteria:

* indications of major or minor pancreatic duct (PD) cannulation; no attempts of cannulation due to inaccessible papilla; cannulation via the papillary fistula; patients with duodenal stenosis or anatomical deformity secondary to prior surgery.
Post-Marketing Study of the Safety of Prevenar (Pneumococcal Conjugate Vaccine, 7-valent)

To collect post-marketing information on the safety of Prevenar in Filipino patients


Eligibility Criteria:
Inclusion Criteria:

* All patients from the study center who received or will receive at least one dose of Prevenar according to the approved product indication.

Exclusion Criteria:

* Previously discontinued Prevenar therapy due to safety concerns.
Study of Recombinant Human Coagulation Factor VIIa for Injection (FⅦa) in Patients With Hemophilia.

Aim of this trial is to assess the pharmacokinetics and pharmacodynamics (PK/PD) of recombinant human coagulation factor VIIa for injection (FⅦa) in patients with hemophilia.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as congenital hemophilia A or B, and meet the following conditions: a. FⅧ\<1% or FIX activity\<2%; b. FⅧ inhibitor or FⅨ inhibitor titer in the screening period\>5 BU (Nijmegen modified Bethesda method of detection).
* Age ≥18 and ≤75 years, male or female.
* No other drugs for the treatment of hemophilia have been used within 48 hours (2 days) before administration, including prothrombin complex and any FVII products, cryoprecipitate, fresh plasma and whole blood, etc.
* No obvious bleeding symptoms during PK medication (no active bleeding).
* Subjects of childbearing age agree to take effective contraceptive measures throughout the trial period, and continue to 28 days after the last medication.
* Volunteer to participate in this study, sign an informed consent form, have good compliance, and be able to cooperate with the experimental observation.

Exclusion Criteria:

* Any other bleeding disease except Congenital hemophilia A or B.
* Patients with any previous medical history or symptoms of arterial or venous thromboembolic events (such as atherosclerosis, myocardial infarction, ischemic stroke, transient ischemic attack, deep vein thrombosis or pulmonary hypertension embolism) or disseminated intravascular coagulation (DIC).
* Baseline and previous values of FⅦ inhibitor or rFVIIa inhibitor is positive.
* Vitamin K deficiency.
* Human immunodeficiency virus (HIV) positive and cluster of differentiation 4 (CD4) count ≤200/μl, the number of virus carriers ≥200 particles/μl or ≥400000 copies/ml.
* Subjects plan to perform elective surgery during the trial period.
* Those who are allergic to test drugs or any excipients.
* Severe anemia and need blood transfusion.
* Platelet count \<80×10\^9/L.
* Obvious liver or kidney damage: ALT or AST\>2.5×ULN, or total bilirubin\>1.5×ULN or serum creatinine\>1.5×ULN.
* Have a history of cardiac surgery and need anticoagulation therapy; severe heart disease, including myocardial infarction, cardiac insufficiency grade 3 or above, the current New York Heart Association cardiac function grade II-IV.
* Hypertension that cannot be controlled with drug treatment: systolic blood pressure\> 150 mmHg or diastolic blood pressure\> 90 mmHg.
* Participated in other clinical studies (except FVIIa, FⅧ and FⅨ trials) within one month before the first medication.
* Diagnosed with hereditary diseases such as fructose intolerance, glucose malabsorption or sucrose-maltase deficiency.
* Alcoholism, drug abuse, mental disorders, other severe acute or chronic diseases, greater abnormal laboratory values, and those who are considered unsuitable by the researcher.
Biomarkers to Distinguish Benign From Malignant Thyroid Neoplasm

This protocol will evaluate microRNA biomarkers in blood and fine-needle aspirate biopsies (FNAB) of thyroid nodules. MicroRNA profiles will be determined and evaluated for their utility in pre-operative diagnosis, in particular to distinguish benign from malignant throid neoplasms. Post-surgical fresh-frozen thyroid cancer tissue will be assessed for somatic mutations, mRNA, and microRNA expression patterns. FFPE tissue will be used to obtain H\&E and unstained slides to specific biomarker results using immunohistochemistry.

This protocol requires the collection of blood (5 ml), fine-needle aspirate biopsies (FNAB), and post-surgical thyroid cancer tissue. The post surgical tissue includes fresh-frozen tissue that is considered waste and in excess of that required for pathologic diagnosis, and archived formalin-fixed, paraffin-embedded tissue (FFPE). The blood will be used as a substrate for assessing known markers, including microRNA expression patterns that may be useful to predict disease and thyroid cancer morphotype. The FNABs will be used to screen the potential of markers for pre-operative diagnosis. The post-surgical fresh-frozen thyroid cancer tissue will be used to isolate DNA and RNA in order to assess somatic mutations (RAS and PAX8/PPAR-gamma rearrangement) and messenger RNA, and microRNA expression patterns. The FFPE tissue will be used to obtain H\&E and unstained slides to validate results using immunohistochemistry. The goal of these studies is to define molecular markers that will accurately distinguish benign from malignant disease and the multiple thyroid cancer phenotypes. Current methods of distinguishing benign from malignant disease requires a detailed post-surgical analysis and no known markers have yet been identified to reliably differentiate the multiple thyroid cancer morphotypes.

Eligibility Criteria:
Inclusion Criteria:

* Patient with palpable thyroid nodule suspicious for thyroid neoplasm
* Patient selected to undergo fine needle biopsy for cytologic diagnosis
* Male (18 years of age or older)
* Female (18 years of age or older)
Real-life Surveillance Study of Patients With Chronic Hepatitis C Treated With PegIntron Injector and Rebetol (Study P04538)(COMPLETED)

The objective of the study is to assess the safety and efficacy of PegIntron injector and Rebetol administered to participants with chronic hepatitis C. Participants will be treated by general practitioners in clinical practice as part of the post-marketing surveillance study. The study will assess the rates of eradication of the hepatits C virus and the rates of serious adverse events reported with PegIntron (1.5 μg/kg/week) and Rebetol (800-1200 mg/day) in common medical practice in Germany.


Eligibility Criteria:
Inclusion Criteria:

* Participants with chronic hepatitis C
* At least 18 years old
* Treatment-naïve or relapse to interferon monotherapy
* Platelets \>= 100,000/mm\^3
* Neutrophil counts \>= 1,500/ mm\^3
* Thyroid Stimulating Hormone (TSH) must be within normal limits
* Hemoglobin \>= 12 gr/dl (females); \>= 13 gr/dl (males)
* Intravenous drug abusers (Ex-IVDA) participants being under stable substitution for at least 6 months
* Women of childbearing potential must have a routine pregnancy test performed monthly during treatment and for 7 months thereafter. Sexually active female participants of childbearing potential must be practicing adequate contraception (intrauterine device, oral contraceptives, implanted contraceptives, surgical sterilization, barrier method, or monogamous relationship with a male partner who has had a vasectomy or is using a condom (+ spermicide) during the treatment period and for 7 months after stopping treatment
* Sexually active male participants must be practicing acceptable methods of contraception (vasectomy, use of condom + spermicide, monogamous relationship with a female partner who practices an acceptable method of contraception) during the treatment period and for 7 months after stopping treatment

Exclusion Criteria:

* Contraindications as per the SPC and approved European labeling
* Hypersensitivity to the active substance or to any inteferons or to any of the excipients
* Pregnant woman
* Woman who are breast-feeding
* Existence of or history of severe psychiatric condition, in particular severe depression, suicidal ideation or suicide attempt
* A history of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease in the previous six months
* Severe debilitating medical conditions, including participants with chronic renal failure or creatinine clearance \< 50 mL/min
* Autoimmune hepatitis or history of autoimmune disease
* Severe hepatic dysfunction or decompensated cirrhosis of the liver
* Pre-existing thyroid disease unless it can be controlled with conventional therapy
* Epilepsy and/or compromised central nervous system function