cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate the Bioequivalence of Astellas Phama Korea Inc. "Harnal-D" in Healthy Volunteers After Meal

This study is an open-label, randomized, fed, single dose, crossover study to evaluate the bioequivalence of Chong Kun Dang Pharmaceutical "Chong Kun Dang Tamsulosin HCl Tablet" and Astellas Phama Korea Inc. "Harnal-D" in healthy volunteers

To healthy subjects of thirty (30), following treatments are administered dosing in each period and wash-out period is a minimum of 1 week.

Reference drug: Harnal-D Tab. / Test drug: Chong Kun Dang Tamsulosin HCl Tab. Pharmacokinetic blood samples are collected up to 48hrs. The pharmacokinetic characteristics and safety are assessed.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy subject older than 19 years men at the screening
2. Individuals without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination(if necessary, EEG, ECG, chest X-ray, endoscope or upper gastrointestinal radiography)
3. Individuals who were deemed to be appropriate as study subjects in accordance with the screening results (laboratory tests, ECG etc.)
4. Individuals who had 18 kg/m2 ≤ Body Mass Index(BMI) ≤ 30kg/m2

   \* BMI = Weight(kg)/ Height(m)2
5. Individuals who had agreed to participate in the study
6. Individuals without mental illness history within five year prior to the screening
7. Individuals without a medical history of gastrointestinal operations that may affect drug absorption
8. Individuals who do not agree to the approved methods of double contraception and using spermicide for up to 7 days after investigational product(s) administration

Exclusion Criteria:

1. Individuals who had enrolled to barbiturate's drugs by induction and inhibition of drug-metabolizing enzymes of drugs within the 1 month
2. Individuals who had excessive drinking within the 1 month

   \*Men: 21 glasses/week exceeded(1 glass: distilled spirits 45 mL, wine 150 mL, beer 360 mL)
3. Individuals who had taken any medication within 10 days prior to the first day of dosing
4. Individuals who were deemed to be inappropriate to participate in the study by the investigator
5. Individuals who had participated of other clinical study or bioequivalence study within the 3 months prior to the first day of dosing
6. Individuals who donated whole blood within the 2 months, or blood components within 1 weeks prior to the first dose of the investigational product(s)
7. Individuals with hypersensitivity (include Vascular edema) to ingredients used in the investigational product(s)
8. Individuals with hereditary diseases of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption etc.
9. Individuals with orthostatic hypotension
10. Individuals with severe hepatopathy
11. Individuals who had taken alpha-1 blocker
12. Individuals who had history of micturition syncope
13. Individuals with nephropathy
14. Elderly person
15. Individuals who had taken PDE5(phosphodiesterase-5) inhibitor
16. Individuals who had taken CYP3A4 inhibitor
17. Individuals who had taken antihypertensive drug(s)
Noninvasive Prenatal Testing

Before and after a patient receives genetic counseling they will be offered the chance to complete the survey, by their counselor. Since each patient sees only one genetic counselor that counselor will be responsible for consenting and giving and collecting the finish surveys. No identifiers will be used. The investigators will emphasize that their answers will remain anonymous throughout the entire process, and that their participation is strictly voluntary. The patient will be provided with a survey and asked to complete this before their genetic counseling session and after.The survey will be returned to the genetic counselor and placed in a locked drawer. Information will also be collected from the medical record including age, pregnancy history and the reason for the visit.

Patients who have abnormal ultrasound findings,advanced maternal age, abnormal serum biochemical screening, or a personal or family history of chromosomal/genetic conditions will be eligible for this study. Prior to receiving genetic counseling, the genetic counselor or her designee will approach the patient asking if she would be willing to participate in a survey that helps us better determine how well patients understand their testing options for the above issues.

The survey consists of two parts. The first part will be taken prior to genetic counseling to see what the patient's baseline understanding of their options are (this is study related.) If the patient agrees to participate in the study, she will then receive the first part of the survey. After completion of the first part of the survey, the patient will then receive genetic counseling (this is standard of care.). Information will also be collected from the medical record including age, pregnancy history and the reason for the visit. After receiving genetic counseling for their specific indication, patients will decide if they want noninvasive prenatal testing, amniocentesis, testing depending what their ultrasound shows, or no testing. After this the patient will be given the second part of the survey to complete (this is study related). Regardless of which testing is elected, (if any), participants are administered the same survey. After completing the survey, the patient will return the form to the genetic counselor or her designee. The recruitment period is expected to last approximately one year. After recruitment is completed, data analysis will take place. Interim data analysis make take place as well.

Patients will not be contacted for research purposes after the survey has been completed.

After patients complete this survey, they will require no further information. They are not being administered a treatment or receiving a direct benefit from participation; the study is designed only to obtain information about patient's decisions, knowledge, and attitudes regarding their testing options.

Eligibility Criteria:
Inclusion Criteria:

* high risk pregnant women seen for genetic counseling

Exclusion Criteria:

* low risk
* not pregnant
Human Fibrinogen - Pharmacokinetics

This study evaluated the single-dose pharmacokinetics of human fibrinogen concentrate and clot strength (maximum clot firmness \[MCF\]) in subjects with congenital fibrinogen deficiency. MCF was measured to demonstrate the functional activity of replacement fibrinogen when a fixed dose of human fibrinogen concentrate was administered.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 6 years
* Documented congenital fibrinogen deficiency: fibrinogen deficiency manifested as afibrinogenemia with plasma fibrinogen activity and antigen at screening undetectable (i.e. \< 20 mg/dL)
* Informed consent signed by subject or legal guardian

Exclusion Criteria:

* Presence or history of hypersensitivity to Human Fibrinogen Concentrate or human plasma proteins,
* Presence or history of deep vein thrombosis, pulmonary embolism, or arterial thrombosis
* Acute bleeding
* History of esophageal varicose bleeding
* End stage liver disease (i.e. Child-Pugh score B or C)
* Planned major surgery with a need for blood transfusion during the PK blood sampling period
* Polytrauma within 1 year prior to enrollment
Exercise Capacity Under Various FiO2 and Oxygen Flow Rates Using HFNC

The purpose of this study is to compare the exercise capacity (6-min walking distance) under the following 4 conditions using High-flow nasal cannula (HFNC); 1. FIO2 value that the minimum SpO2 value in a 6-minute walking test (6MWT) is 86-88%, and a flow of 10 L/min 2. FIO2 value that the minimum SpO2 value in a 6MWT is 86-88%, and a flow of 40-50 L/min 3. FIO2 value that the minimum SpO2 value in a 6MWT is 92-94%, and a flow of 10 L/min 4. FIO2 value that the minimum SpO2 value in a 6MWT is 92-94%, and a flow of 40-50 L/min

In the pervious study, the investigators demonstrated that 4 weeks of training using both high FIO2 and high flow through an HFNC significantly improved the 6MWD compared with training using a 6 L/min nasal cannula. However, it was unclear whether the effects of pulmonary rehabilitation under HFNC were due to high FIO2, high flow rate, or a synergistic effect. It is also unknown whether there are differences in the effects of pulmonary rehabilitation under HFNC for each underlying disease.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with a minimum SPO2 of 88% or less during performing 6MWT under HFNC (FIO2 0.21 and a flow rate of 10L/min)
* Subjects who have been clinically stable for the last 2 weeks
* Subjects with written informed consent to participate in this study

Exclusion Criteria:

* Subjects with severe cardiovascular disease, liver disease, neurological disease, and renal failure
* Subjects who needed antimicrobial agent or steroid administration for pneumonia and exacerbation of respiratory disease in the last 2 weeks
* Subjects who cannot undergo 6MWT due to severe heart failure, arteriosclerosis obliterans or spinal disease
Pilot Study With a Diffractive Trifocal IOL (POD AY 26P FineVision)

The principal objective of the study is to determine the visual acuity at far, intermediate and near distances tested with optotypes at different distances from the eyes and tested with defocus addition lenses of patients implanted bilaterally with the POD 26P AY FineVision.

Secondary objective will be to test the glare and contrast sensitivity.

This study is a pilot study. As such it will recruit a limited number of patients : 20. Patients recruited will suffer from cataract, have no comorbidity, expressed the desire for spectacle independence and have realistic expectations.

Descriptive statistics will be used to determine the visual acuities at any distance. The occurence of glare and the determination of the contrast sensitivity will also be determined.

Eligibility Criteria:
Inclusion Criteria:

* - Age-related cataract
* Preoperative Corneal astigmatism \< 0.75 D
* Age 21 and older
* Visual Acuity \> 0.05
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant.
* Patient willing multifocal implantation and with realistic expectations.

Exclusion Criteria:

* Relevant other ophthalmic diseases such as pseudoexfoliation syndrome, floppy iris syndrome, corneal pathologies, retinal pathology (diabetic maculopathy, myopic maculopathy, age related macular degeneration...)
* Previous ocular surgery or trauma.
Analysis of Postoperative Ocular Surface Changes and Intervention Effect After PPV in MGD Dry Eye Patients

AIM: To observe ocular surface changes after phacovitrectomy in patients with mild to moderate meibomian gland dysfunction (MGD)-type dry eye and track clinical treatment response using a Keratograph 5M and a LipiView interferometer.

METHODS: Forty cases were randomized into control group A and treatment group B; the latter received meibomian gland treatment 3 days before phacovitrectomy and sodium hyaluronate before and after surgery. The average non-invasive tear film break-up time (NITBUTav), first non-invasive tear film break-up time (NITBUTf), non-invasive measured tear meniscus height (NTMH), meibomian gland loss (MGL), lipid layer thickness (LLT) and partial blink rate (PBR) were measured preoperatively and 1 week, 1 month and 3 months postoperatively.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of dry eye
* Clinical diagnosis for MGD

Exclusion Criteria:

* eye trauma or eye surgery within the prior 6 months
* use of drugs that affect tear secretion and the stability of the tear film (including anti-glaucoma drugs, cortisol drugs, etc.) within the prior 6 months
* other diseases that affect the function of the eye surface, such as meibomian gland cysts, blepharitis, eyelid valgus, incomplete closure, chronic tear cystitis, corneal disease, glaucoma, or optic neuropathy
* intraoperative suture fixation or closure of a corneal, conjunctival, or scleral incision
* long-term postoperative intraocular hypertension that could not be controlled easily with oral drugs and required puncture and drainage through the anterior chamber
* postoperative corneal epithelial defects lasting more than 1 week or necessitating the use of contact lenses for treatment
* the need for a second operation during the study follow-up eye trauma or eye surgery within the prior 6 months
* use of drugs that affect tear secretion and the stability of the tear film (including anti-glaucoma drugs, cortisol drugs, etc.) within the prior 6 months
* other diseases that affect the function of the eye surface, such as meibomian gland cysts, blepharitis, eyelid valgus, incomplete closure, chronic tear cystitis, corneal disease, glaucoma, or optic neuropathy
* intraoperative suture fixation or closure of a corneal, conjunctival, or scleral incision
* long-term postoperative intraocular hypertension that could not be controlled easily with oral drugs and required puncture and drainage through the anterior chamber
* postoperative corneal epithelial defects lasting more than 1 week or necessitating the use of contact lenses for treatment
* the need for a second operation during the study follow-up
Safety and Efficacy Study of CINRYZE for Prevention of Angioedema Attacks in Children Ages 6-11 With Hereditary Angioedema

Primary Objective - To assess the relative efficacy of two dose levels of CINRYZE (500 Units and 1000 Units) administered by intravenous (IV) injection every 3 or 4 days to prevent angioedema attacks in children 6 to 11 years of age with hereditary angioedema (HAE).

Secondary Objectives - To assess the safety and tolerability, characterize the pharmacokinetics (PK) and pharmacodynamics (PD), and assess the immunogenicity of two dose levels of CINRYZE administered by IV injection in children 6 to 11 years of age with HAE.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Type I or Type II HAE.
* History of angioedema attacks.

Exclusion Criteria:

* History of bleeding or clotting abnormality.
* Diagnosis of acquired angioedema or known to have C1 INH antibodies.
* History of allergic reaction to C1 esterase inhibitor or other blood products.
* Receipt of any experimental agents other than those required for prevention or treatment of angioedema attacks within 30 days prior to screening.
Cost-consequence Analysis of Influenza Vaccination in a Teaching Hospital in Rome

Flu vaccination, as well as being effective to prevent seasonal influenza, decreases staff illness and absenteeism and reduces costs resulting from loss of productivity. Despite the effectiveness of flu vaccination, the seasonal coverage among healthcare workers is usually low. The aim of this retrospective observational study is to analyze the vaccination coverage rate among all employees (healthcare workers and administrative staff) of a large teaching hospital in Rome during the 2017-2018 influenza season, to perform a cost-consequence analysis of influenza vaccination (by evaluating the absenteeism due to illness in the epidemic period), and to assess the impact of vaccination in terms of both costs and sick days.


Eligibility Criteria:
Inclusion Criteria:

• Healthcare workers at Fondazione Policlinico Universitario "A.Gemelli" IRCCS

Exclusion Criteria:

• Healthcare workers not working at Fondazione Policlinico Universitario "A.Gemelli" IRCCS
Communication Training in Promoting Employment Retention Among Cancer Patients

This randomized clinical trial studies communication training in promoting employment retention among cancer patients. Communication training may improve patient-employer communication and increase the likelihood that cancer patients will remain employed, reduce patients' time away from work, and increase workplace accommodations that enable patients to balance treatment and work.

PRIMARY OBJECTIVES:

I. Demonstrate the efficacy of the DVD intervention to a) increase patients' knowledge of their legal rights in the workplace, b) improve patient perceptions of workplace communication about the impact of cancer treatment and ongoing surveillance, and c) increase the number of requested and received workplace accommodations.

II. Compare employment status (employed vs non-employed) between the treatment and control arms.

III. Compare weekly hours of work between the treatment and control arms.

OUTLINE: Patients are randomized to 1 of 2 arms.

Arm I: Patients receive a DVD containing educational information about patients' legal rights in the workplace and communication skills demonstrated through four scenarios depicting a variety of employer-employee communication challenges for patients, provided by the Legal Information Network for Cancer (LINC) group.

Arm II: Patients receive information about the LINC group

After completion of study, patients are followed up at 4, 12, and 52 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a new, primary diagnosis of a solid tumor
* Employed full- or part-time at the time of enrollment
* English-speaking
* Able to participate in telephone interviews
* Able to view a 1-hour DVD
* Patients must have a treatment plan that includes chemotherapy and be within 2 weeks of initiating chemotherapy

Exclusion Criteria:

* Patients with prior cancer except non-melanoma skin cancer
Weaning of Norepinephrine Guided by the Dynamic Arterial Compliance in Cardiac Surgery Post Operative.

After cardiac surgery, vasoplegic syndrome is a hemodynamic state characterized by profound hypotension associated with a decrease in systemic vascular resistance. The care of this disease is based on the intravenous administration of a vasopressor, usually norepinephrine. During the recovery phase, weaning of norepinephrine, is an important step in which any lack of preload (blood volume) initial or secondary can be, and increase tissue malperfusion.


Eligibility Criteria:
Inclusion Criteria:

* Major patient ≥ 18 years
* Patient operated a cardiac surgery for myocardial revascularization (CABG surgery) or surgical correction of valvular or combined surgery (CABG and valve disease) or surgery the ascending aorta and cardiac surgery with vasoplegic syndrome treated by norepinephrine
* Signed consent
* Affiliation to social assurance

Exclusion Criteria:

* Permanent atrial fibrillation
* Treatment with dobutamine and/or epinephrine
* Pregnant woman
* Patient under guardianship or private public law
* Internal pacemaker
* Hypothermia
* Patient refusal
Investigation of Non-CE Marked Intermittent Catheters for Females

Investigation of novel non-CE marked intermittent catheters. The study was a randomized, single blinded, cross-over investigation comparing two new catheters for females with a comparator catheter.

The CP324 study investigated a novel non-CE marked intermittent catheter, designed in two different variants, Variant 1 and Variant 2, respectively, and was conducted in Denmark. The study was a randomized, single blinded, cross-over investigation comparing the two new variant catheters with a comparator catheter in 15 female IC users.

For each participant, the study thus contained three test visits/treatment arms (Comparator, Variant 1 and Variant 2, respectively), to which the 15 participants were randomized using a randomization sequence of six (i.e., there were six different random options for the order in which the participants tested the three catheters). There were 4-14 days between the test visits.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Minimum 18 years of age and with full legal capacity
* Daily intermittent catheterization for bladder management, with at least two catheters used on average pr. day, during the last 3 months
* Ability to self-catheterize
* Written informed consent, signed letter of authority and signed secrecy agreement given

Exclusion Criteria:

* Breastfeeding
* Pregnancy (based on pregnancy test - urine)
* Participation in any other clinical study during this investigation
* Symptoms of urinary tract infection as judged by the investigator
* Any know allergies towards ingredients in the products
* Relevant medical history that would prevent the subject from participation (investigators judgement)
Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Elderly Subjects

This is a follow-up study to the core study NCT00269672 (6115A1-500). This study will further evaluate the safety, tolerability, and immunogenicity of 13-valent pneumococcal conjugate vaccine (13vPnC) when administered to subjects who have already received one dose of 13vPnC, and one dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) one year later. This study will determine if a subsequent dose of 13vPnC one year later results in similar or greater immune response (body's ability to protect against disease) than that measured after the initial dose of 13vPnC.


Eligibility Criteria:
* Previous participant of study 6115A1-500 and received 13vPnC +AlPO4 / 23vPS
* Generally healthy male or female adults 65 years of age or older
* Available for the duration of the trial - approximately 1 month
* No history of severe adverse reaction associated with a vaccine

  * MMSE score less than or equal to 21 was an exclusion criteria.
Ga68-FAPI-46 PET/CT for Preoperative Assessment of Peritoneal Carcinomatosis

This is a prospective, phase II, non-randomized clinical imaging trial. Ga68-FAPI-46 is a novel radiotracer used in PET/CT imaging, targeting a protein of the tumor microenvironment called FAP (Fibroblast activation protein).

The aim of the study is to assess the accuracy of Ga68-FAPI-46 PET/CT for preoperative assessment of peritoneal carcinomatosis in colorectal and ovarian cancer.

Fibroblast activation protein (FAP) is a type II transmembrane glycoprotein expressed on the surface of cancer-associated fibroblasts (CAFs) in the stroma of various tumor entities. Recently, radiolabeled molecules targeting the FAP, called FAP inhibitors (FAPI) labelled with Gallium-68, have been developed for molecular imaging with PET/CT (positron emission tomography/computed tomography). This radiotracer often presents a higher cancer lesion detectability than F18-FDG (fluorodeoxyglucose), partly thanks to its higher tumour-to-background ratio achieved by a low background activity, particularly in the brain, abdominal cavity and liver. These advantages have resulted in a superior sensitivity of Ga68-FAPI PET/CT over F18-FDG and higher SUV (standardized uptake value) in evaluating various types of cancer. In this context, Ga68-FAPI PET/CT seems promising to further study as a clinical imaging modality for preoperative assessment of peritoneal carcinomatosis.

In this study, the investigators correlate Ga68-FAPI PET/CT findings in terms of peritoneal involvement with intraoperative findings based on histopathology and try to find out how accurate Ga68-FAPI PET/CT is for the preoperative assessment of peritoneal carcinomatosis.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven colorectal and ovarian cancer.
* Known or suspected peritoneal metastases from the tumour of origin.
* Scheduled for peritoneal complete cytoreductive surgery with curative intent with or without neoadjuvant chemotherapy.
* ECOG (Eastern Cooperative Oncology Group) Performance status ≤2.
* Signed written informed consent obtained before any study-specific screening procedures.

Exclusion Criteria:

* Non-resectable extra-abdominal metastasis and/or \>3 hepatic metastases on standard work-up
* Known chronic inflammatory conditions including the intestinal system (eg. inflammatory bowel disease, Crohn's disease)
* Pregnant and lactating women
* Previous or concurrent malignancy diagnosed within the last 3 years except adequately treated in situ carcinoma of the cervix uteri and basal or squamous cell skin cancer.
* Subjects with another significant medical condition which, in the investigator's opinion, may interfere with the completion of the study.