cyrilzakka/clinical-trials huggingface dataset:
Dose-Ranging Study of Recombinant Human Papillomavirus Virus 16/18 Bivalent Vaccine

This is a phase II clinical study of the novel recombinant HPV 16/18 bivalent vaccine expressed in E. coli.

The primary purpose of this study is to evaluate which dosage of the HPV vaccine can induce higher antibody and at the same time caused less adverse events.

The secondary purpose of this study is to to evaluate the safety and immunopersistence of the study vaccine.

Totally 1600 healthy women of 18-25 years of age were enrolled. The participants were randomly stratified into 4 groups and receive different dosage of human papillomavirus (HPV) vaccine or placebo administered intramuscularly according to a 0-1-6 month schedule. The women were actively monitored for adverse events for 1 month after each injection. Severe adverse events during the trial were followed up. Serum samples from all the subjects would be collected on day 0, 7m, 24m, 48m and 72m to evaluate the immunogenicity and immuno-persistency.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent from the subject prior to enrolment;
* Female between, and including, 18 and 25 years of age at the time of enrolment;
* Subjects must be free of obvious health problems;
* Not pregnant and having no plan for pregnancy;

Exclusion Criteria:

* Pregnant or breastfeeding or having plan for pregnancy during the whole study (Month 0-7);
* Previous vaccination against HPV;
* Having severe allergic history or other immunodeficiency;
* Chemotherapy and other immunosuppressive agents using;
Innovative Pulmonary Rehabilitation Telehealth Program for Improving COPD Patient Outcomes

Researchers want to learn more about telehealth pulmonary rehabilitation programs that help people with Chronic obstructive pulmonary disease (COPD) improve physical activity and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Hospital discharge diagnosis of COPD
* Spirometry-confirmed evidence of COPD Global Initiative for Chronic Obstructive Lung Disease (GOLD) stages I to IV
* Access to internet connection and knowledge on use of web-based programs

Exclusion Criteria:

* Persons with additional significant comorbidities including cancer, cardiac disease and physical impairments
* Non-English speaking persons
* The inability to provide an informed consent
Thin Strut Sirolimus-eluting Stent in All Comers Population vs Everolimus-eluting Stent

The primary objective of this study is to compare the performance of SUPRAFLEX to that of XIENCE in an all-comers patient population with symptomatic ischemic heart disease. The patients will be followed through 3 years for major clinical events.

This is a prospective, randomized, 1:1 balanced, controlled, single-blind, multi-center study comparing clinical outcomes at 12 months between SUPRAFLEX and XIENCE in a "Real world, all comers" patient population (patients with symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, and acute coronary syndromes, who qualify for percutaneous coronary interventions). The objective is to compare the SUPRAFLEX SES with the XIENCE EES with respect to target lesion failure (TLF) at 12 months in a non-inferiority trial in a "real world" patient population.

All patients will be (at minimum) contacted at 30 days, 6 months, and 12 months post procedure to assess clinical status and adverse events. The 30 day and 12 month will be a clinic visit. All patients will have annual contact through 3 years follow-up to assess clinical status and adverse events.

Eligibility Criteria:
Inclusion Criteria:

All comers" patients:

* Male or female patients 18 years or older;
* Presence of one or more coronary artery stenoses of 50% or more in a native coronary artery or in a saphenous venous or arterial bypass conduit suitable for coronary stent implantation.
* The vessel should have a reference vessel diameter ranging from ≥2.25 mm to ≤4.5 mm (no limitation on the number of treated lesions, vessels, or lesion length); All lesions of the patient must comply with the angiographic inclusion criteria.
* The patient (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed. Patient is willing to comply with all protocol-required evaluations.

Exclusion Criteria:

* Known pregnancy or breastfeeding at time of randomization;
* Known contraindication or hypersensitivity to sirolimus, everolimus, cobalt-chromium, or to medications such as aspirin, heparin, bivalirudin, and all of the following four medications: clopidogrel bisulfate, ticlopidine, prasugrel, ticagrelor;
* Any PCI treatment within 6 months (\<6 months) prior to the index procedure.
* Concurrent medical condition with a life expectancy of less than 12 months.
* The patient is unwilling/ not able to return for outpatient clinic at 12 months follow-up.
* Currently participating in another trial and not yet at its primary endpoint.
Somatuline Autogel: Acromegaly Self/Partner Injection Study

The purpose of this study is to allow patients with acromegaly, or their partners, to learn how to successfully inject Somatuline Autogel at home. Ability to perform unsupervised injections whilst maintaining adequate disease control will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* The patient must have a clinical diagnosis of acromegaly
* The patient must have been tested and shown to have a GH level less than or equal to 10 micrograms/L within 28 days prior to the baseline visit
* The patient must be currently treated with Somatuline Autogel and have been stable on their current dose for at least 6 months immediately prior to screening
* The patient must be able to store study medication in a refrigerator in their own home

Exclusion Criteria:

* The patient has had pituitary surgery (adenomectomy) within 6 months prior to screening
* The patient has received pituitary radiotherapy within one year prior to screening
* The patient is likely to require pituitary surgery (adenomectomy) or to receive radiotherapy during the study period
* The patient is currently receiving a GH antagonist or a somatostatin analogue other than Somatuline Autogel
Study of Clinical Types and Surgical Out Come of Pediatric Exotropia

study aiming to evaluate all children presented to strabismus clinic in ophthalmology department at sohag university hospital with divergent squint (exotropia) and to record surgical outcome of those who underwent strabismus surgery in our hospital

A hospital-based, prospective, interventional study include infants and children up to the age of 15 years with Primary Concomitant divergent squint (1ry concomitant exotropia),Candidate for surgical correction of squint.

Each patient will be subjected to Detailed history and Full preoperative ophthalmic \& orthoptic evaluation including: Visual acuity , ocular motility in the 6 cardinal directions, Hirschberg test \& angle of deviation.

,Cover test \& prism cover test for distant \& near fixation,Cycloplegic refraction , Anterior segment examination, fundus examination.

_ post operative Follow-up regimen:

1. Children will be examined after surgery on: 1st postoperative day, 1st week, 1st month, 3rd month, and 6 months postoperatively.
2. The following will be recorded for each patient: Visual acuity, cover test, ocular motility testing, cover test and prism cover test, the degree of postoperative eye position, presence of over-correction or under-correction, and presence of any other complications.

Eligibility Criteria:
Inclusion Criteria:

1. Infants and children up to the age of 15 years.
2. Primary Concomitant divergent squint (1ry concomitant exotropia)
3. Candidate for surgical correction of squint

Exclusion Criteria:

1. Children with:

   1. Paralytic squint
   2. Consecutive exotropia
   3. Any neurological disorder
   4. History of previous squint surgery
   5. History of previous other ocular surgery (e.g. congenital cataract \& glaucoma)
2. Children who missed follow up.
HIPEC as Neoadjuvant Treatment for Resectable Pancreatic Adenocarcinoma

This single-center, prospective proof-of-concept study is designed to evaluate the surgical outcomes and clinicopathologic results of neoadjuvant hyperthermic intraperitoneal chemotherapy (HIPEC) in conjunction with perioperative systemic chemotherapy (SCT; neoadjuvant and adjuvant) and pancreaticoduodenectomy (PD) in a small cohort of patients having T1-T3 resectable pancreatic ductal adenocarcinoma (PDAC) with one or more high-risk clinical features. The investigators hypothesize that HIPEC administered in this clinical course will reduce postoperative peritoneal disease recurrence. The investigators also expect that local recurrence of disease will be reduced. The primary aim of this study is to compare 2-year peritoneal disease-free survival between patients receiving the experimental therapy (neoadjuvant HIPEC + SCT + PD) with historical controls receiving standard therapy (SCT + PD). Secondary aims are to determine the clinical feasibility and outcomes of neoadjuvant HIPEC for resectable PDAC using patient demographics and disease characteristic data.


Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of pancreatic ductal adenocarcinoma (PDAC) confined to the head of the pancreas classified as T1-T3 with one or more of the following high-risk clinical features:

  * Carbohydrate antigen (CA) 19-9 greater than 1,000 U/mL with a normal bilirubin;
  * Vascular involvement; and/or
  * Suspicious regional lymphadenopathy
* Intention to undergo open pancreaticoduodenectomy (standard Whipple or pylorus-preserving pancreaticoduodenectomy) as treatment for PDAC
* Adequate clinical condition to undergo preoperative (neoadjuvant) hyperthermic intraperitoneal chemotherapy
* Adequate clinical condition to undergo perioperative systemic chemotherapy
* White blood cell count of at least 3000/mL
* Platelet count of at least 100,000/mL
* Normal creatinine (\< 2 mg/dL) or creatinine clearance of at least 50 mL/min
* Willing and able to give informed consent

Exclusion Criteria:

* Evidence of locoregional spread (carcinomatosis of peritoneal surfaces, mesenteric arteries, or body/tail of pancreas) or distant (liver, lung, or other) metastases (histological, CT, or MRI confirmation)
* Non-curative intent of treatment (≥R2 resection)
* Body mass index (BMI) \> 35
* Previous history of pancreatic resections for tumors in the body and/or tail of the pancreas, distal cholangiocarcinoma, duodenal carcinoma, neuroendocrine tumors, cyst-adenocarcinoma, or solid and papillary tumors.
* Unstable or uncompensated respiratory or cardiac disease
* Severe hepatic or renal dysfunction
* Bleeding diathesis or coagulopathy
* Pregnant or nursing women
Atorvastatin in Patients With Ulcerative Colitis

Ulcerative colitis (UC) is an idiopathic, chronic inflammatory disease characterized by diffused inflammation of the colon and rectum mucosa; however, the exact underlying mechanisms of UC remain poorly understood. Statins exert numerous pleiotropic effects including anti-inflammatory, antioxidant properties, endothelial function improvement, and immunomodulation independent of their basic lipid-lowering property.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Both male and female will be included
* Negative pregnancy test and effective contraception

Exclusion Criteria:

* Breastfeeding
* Significant liver and kidney function abnormalities
* Colorectal cancer patients
* Patients with severe UC
* Patients taking rectal or systemic steroids
* Patients taking immunosuppressives or biological therapies
A Randomized Trial of Frovatriptan for the Intermittent Prevention of Menstrual Migraine

The primary objective of this study was to determine whether frovatriptan was effective in the prevention of menstrually associated migraine (MAM) headaches when compared to placebo. Secondary objectives included determining the effectiveness of frovatriptan in reducing the incidence, severity and duration of MAM headaches and associated symptoms, to evaluate the safety and tolerability of the two frovatriptan dosing regimens and to compare the effectiveness of these regimens in the prevention of MAM headaches. In this cross-over study, patients treated each of 3 perimenstrual periods (PMPs) with placebo, frovatriptan 2.5 mg daily (QD) and 2.5 mg twice daily (BID) for 6 days, starting 2 days before the anticipated onset of a MAM headache.

A statistically significant reduction in the incidence of MAM headache (p\<0.0001) was observed with both dosing regimens of frovatriptan when compared to placebo. Additionally, the frovatriptan BID regimen was superior to the frovatriptan QD regimen in the prevention of MAM headache (p\<0.001). Significant reductions in MAM headache severity and duration, the incidence of associated symptoms and characteristics, and the use of rescue medication were observed when the PMP was treated with frovatriptan, compared to placebo. Both dose regimens of frovatriptan were equally well tolerated and no cardiovascular or other safety and tolerability concerns arose with repeated administration of frovatriptan over a 6 day period.


Eligibility Criteria:
Inclusion Criteria:

* Females aged 18 years and over
* 12 month or more documented history of menstrual migraine headache, according to International Headache Society classification
* An average frequency of MAM attacks in at lease 3 out of 4 menstrual cycles
* Regular predictable menstrual periods
* Able to accurately predict the onset of MAM headaches occurring between Day -2 and Day +4 of menses
* Able and willing to sign informed consent to comply with study procedures, including completion of diary cards

Exclusion Criteria:

* More than three migraine attacks per month that were not MAM attacks
* Coronary artery disease including coronary vasospasm
* Significant cerebrovascular disease including basilar or hemiplegic migraine
* Uncontrolled hypertension
* Severe hepatic or renal insufficiency
* More than 15 headache days per month
* Any other condition or serious illness which would interfere with optimal participation in the study
* History of clinically relevant allergy, including that to frovatriptan or other triptans
* Pregnant or breast feeding or intending to become pregnant or to breast-feed during study period
* Participated in other frovatriptan menstrual migraine prevention studies
* Use of another investigation drug within 30 days or 5 half-lives (whichever is longer) before the screening visit
Fentanyl Transdermal Matrix Patch ZR-02-01 to Treat Chronic, Moderate to Severe Non-Malignant Pain

The purpose of this study is to evaluate the safety of the matrix fentanyl patch ZR-02-01 in providing relief of non-malignant chronic pain.

This study will evaluate the safety of the matrix fentanyl patch. The study will be conducted in opioid-tolerant patients with moderate to severe non-malignant chronic pain currently taking an around-the-clock opioid. Patients will discontinue their current opioid regimen and begin using ZR-02-01 as soon as possible under the direction of the physician investigator upon entry into the study. Patient's dose of ZR 02 01 will be determined by the investigator using sponsor-provided conversion. Pain therapy will be under the supervision of the physician investigator.

Eligibility Criteria:
Inclusion Criteria:

* Patient is at least 18 and no older than 75 years of age
* Patient has moderate to severe, non-malignant chronic pain that is expected to last for at least 12 months and is currently taking an around-the-clock opioid to treat his/her pain
* Patient is already receiving opioid therapy, has demonstrated opioid tolerance, and requires a total daily dose of opioids at least equivalent to 25 mcg/hr of transdermal fentanyl. Patients who are considered opioid-tolerant are those who have been taking a daily dose of at least 30 mg of oral morphine or morphine equivalent opioid for at least 2 weeks.

Exclusion Criteria:

* Patient has active cancer
* Patient has a history of substance abuse or has a substance abuse disorder
To Compare the Safety and PK/PD Characteristics of Subjects With Between Hepatic Impairment and Normal Hepatic Function

This study aims to evaluate the pharmacokinetics, pharmacodynamics, safety, and tolerability of DWP16001 in subjects with hepatic impairment compared with subjects with normal hepatic function.

The study design is An open-label, multi-center, parallel, single oral dose study.

Eligibility Criteria:
Inclusion Criteria:

1. A person who has decided to participate voluntarily and agreed in writing prior to the screening procedure after understanding the detailed explanation of this clinical trial.
2. A person who is 19 years of age or more and under 80 years of age at the time of screening.
3. Those with a weight of 45.0 kg or more and 90.0 kg or less and a body mass index (BMI) of 18.0 kg/m2 or more and 30.0 kg/m2 or less.

Exclusion Criteria:

1. A person who has a history of gastrointestinal diseases (e.g., ulcer, inflammatory bowel disease, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (except simple appendectomy or hernia surgery) that may affect the absorption of DWP16001.
2. Those who are hypersensitive to drugs and other drugs (aspirin, antibiotics, etc.) including the SGLT2 inhibitor family or who have a history of clinically significant hypersensitivity reaction.
3. Serum Cr \>1.5mg/dL or eGFR (CKD-EPI Cr) \<60mL/min/1.73m2
4. Those who have used SGLT2 inhibitor family drugs within two weeks of the scheduled date of administration of DWP16001.
Vaginal Misoprostol and Foley Catheter for Induction of Labor

to compare between sequential and concurrent use of vaginal misopristol plus foleys catheter for induction of labor

two groups of patients who are eligible for labor induction were randomized to either sequential use of vaginal misopristol plus foleys catheter or concurrent use of vaginal misopristol plus foleys catheter.

Eligibility Criteria:
Inclusion Criteria:

* Indication for labour induction Term pregnancy with alive fetus Bishop score less than five

Exclusion Criteria:

* Age less than 18 years Previous uterine scar Nonvertex presentation Non-reassuring fetal status Fetal anomalies Fetal growth restriction Genital bleeding Tumors, malformations and/or ulcers of vulva, perineum or vagina
Prospective Clinical Trial Comparing Infraclavicular Versus Axillary Approach to Brachial Plexus Block

The brachial plexus block is an anesthetic technique often used for surgical procedures of the upper limb. To get the brachial plexus block, several routes can be used, including the axillary and infraclavicular approach.

Few studies have compared these techniques, considering the time to perform the block, the onset time and success rate, with conflicting results. Furthermore, there is little information in the literature comparing the length of postoperative analgesia provided by these techniques.

Therefore, the investigators designed this study in order to elucidate the differences between these two techniques to assist the anesthesiologist to choose the best of them in clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* age older than 18 years and less than 70 years
* consent informed signed by the patient
* candidates for surgical intervention of scaphoid fractures, distal radius fractures and wrist arthrodesis
* American Society of Anesthesiology physical status I, II and III
* body mass index (BMI) \<35 kg / m².

Exclusion Criteria:

* cognitive impairment or active psychiatric condition
* infection at the puncture site
* bleeding disorders
* history of allergy to ropivacaine
Long-term Safety of BCX9930 in Participants With Paroxysmal Nocturnal Hemoglobinuria

This study is designed to provide continued access to BCX9930 for participants currently receiving treatment with BCX9930 in a BioCryst-sponsored clinical study for paroxysmal nocturnal hemoglobinuria (PNH) who, in the opinion of the investigator, would benefit from continued treatment with BCX9930 and who do not have access to other treatment options.


Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant, non-lactating female participants
* Are receiving treatment with BCX9930 in another clinical study of PNH and, in the opinion of the investigator, have benefited from treatment with BCX9930 and would benefit from continued treatment with BCX9930, and who do not have access to other treatment options

Exclusion Criteria:

* Any clinically significant medical or psychiatric condition including alcohol or drug dependency that, in the opinion of the investigator or sponsor, would interfere with the participant's ability to participate in the study or increase the risk of participation for that participant
* An ongoing adverse event, including a laboratory abnormality, or other unacceptable toxicity that, in the judgment of the investigator, compromises the ability of the participant to continue study-specific procedures or it is considered not to be in the participant's best interest to continue or benefit-risk assessment is no longer in favor of the participant's continued treatment
Risk Stratification Using PET in HCM

The overall rationale is to reduce the risk of sudden cardiac death in individuals with hypertrophic cardiomyopathy (HCM). The novel approach of this study is to correlate Positron Emission Tomography (PET) findings to ventricular arrhythmias detected by the implantable cardioverter defibrillator (ICD). This could potentially lead to an improved risk stratification of HCM patients.

Positron Emission Tomography (PET) is a functional imaging technique that utilizes radioactive tracers to gain information on physiological or pathophysiological processes in vivo. Different tracers can provide information on different processes of interest. In cardiology, metabolic processes consuming oxygen (aerobic) can be studied with 11-Carbon-Acetate, sympathetic innervation can be studied with 11-Carbon-hydroxyephedrine and using 15-Oxygen-water the myocardial blood flow. Structural information of the heart such as left ventricular mass, left ventricular volumes and wall thickness can also be calculated with PET.

The aim is to correlate PET parameters and burden of ventricular arrhythmias in order to improve risk stratification in HCM.

Eligibility Criteria:
Inclusion Criteria:

* Hypertrophic cardiomyopathy, implantable cardioverter defibrillator, informed consent

Exclusion Criteria:

* Patients younger than 18 years, pregnancy, breast feeding, claustrophobia, intolerance/allergic reaction to adenosin or mannitol, severe hypotension, unstable angina pectoris, incompensated systolic heart failure, increased intracranial pressure, hypovolemia, dipyramidole.
Analysis of Health Status of Сomorbid Adult COVID-19 Patients Hospitalised in Second Wave of SARS-CoV-2 Infection

Comparison of COVID-19 disease course in hospitalized patients infected by SARS-CoV-2 in first and second waves of the novel coronavirus infection

Non-commercial depersonalized multi-centered registry study on analysis of chronic non-infectious diseases dynamics after SARS-CoV-2 in first and second waves of the novel coronavirus infection in cohort of Russian adult patients.

Retrospective analysis of medical histories and outcomes in adults with pre-existing conditions after SARS-CoV-2 infection. Comorbidities worsening risk factors measuring through evaluation of range of indicators such as dynamics of diabetes, CKD, COPD, bronchial astma, incidence of hypertonic crises, vascular events and others.

Eligibility Criteria:
Inclusion Criteria:

Suspected or confirmed COVID-19 (according to results of swab-test, antibody test, computed tomography or radiography image)

Exclusion Criteria:

1. Unwillingness to participate in the study;
2. Age under 18.