cyrilzakka/clinical-trials huggingface dataset:
A Phase III Study of a 2-dose Regimen of a Multivalent Human Papillomavirus (HPV) Vaccine (V503), Administered to 9 to 14 Year-olds and Compared to Young Women, 16 to 26 Years Old (V503-010)

This was a 37-month safety and immunogenicity study conducted in boys and girls 9 to 14 years of age and in young women 16 to 26 years of age. From this study, the goal was to establish that the investigational 2-dose regimens (0, 6 months and 0, 12 months) studied in boys and girls 9 to 14 years of age are generally safe and immunogenic, with an antibody response that is not inferior to that observed in young women 16 to 26 years of age who received the standard 3-dose regimen of V503 (i.e., the population and dose regimen used to establish V503 efficacy).


Eligibility Criteria:
Inclusion Criteria:

All Participants:

-Judged to be in good physical health on the basis of medical history, physical examination and laboratory results

Boys and Girls 9 to 14 Years:

-Must not have had coitarche and does not plan on becoming sexually active during the vaccination period

Women 16 to 26 Years:

* Has never had a Papanicolaou (Pap) test or only had normal Pap test results
* A lifetime history of 0 to 4 male and/or female sexual partners

Exclusion Criteria:

All Participants:

* Known allergy to any vaccine component
* History of severe allergic reaction that required medical intervention
* Thrombocytopenia or any coagulation disorder
* Females only: participant is pregnant or expecting to donate eggs during day 1 through month 7
* Currently immunocompromised, or been diagnosed with immunodeficiency
* Had a splenectomy
* Receiving or has received immunosuppressive therapies within the last year
* Received any immunoglobulin product or blood-derived product within 3 months
* Received a marketed HPV vaccine or has participated in an HPV vaccine clinical trial
Impact of the Information Leaflet on the Anesthesia Knowledge and Anxiety Levels of Children and Parents

The study includes applying a questionnaire to each child and their parents who applied to the anesthesia outpatient clinic for the gastroenterological endoscopic procedure. Children and parents will be divided into two groups, those who received and those who did not receive information leaflet. With the questionnaire both groups will be compared in terms of knowledge level and anxiety level.

All children under the age of 18, who meet the inclusion criteria, applied to the outpatient clinic for the preoperative anesthesia evaluation will be included in the study. During the preoperative anesthesia examination, pediatric patients and their parents will be informed about the study, their consent will be obtained, and their demographic data will be recorded.

Information leaflets will be given to the one group in that both the child and their parents will read it before the endoscopic procedure. Children will handed leaflet appropriate for their age. The other group will not receive information leaflets. Routine information about anesthesia will be given to both groups.

Demographic data, m-YPAS(The modified Yale Preoperative Anxiety Scale), APAIS(Amsterdam Preoperative Anxiety and Information Scale) will be evaluated for both groups before anesthesia induction.

The anesthesiologist evaluate anxiety of children, will not know whether the patients received an information leaflets.

Parents will be asked to fill out the questionnaire in the waiting room. Anxiety scores will be evaluated by APAIS. The source of their knowledge about anesthesia, how anesthesia applications are made during endoscopy procedures and what their fears about anesthesia are will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* All children under the age of 18 and their parents who applied to the anesthesia outpatient clinic before the gastroenterological endoscopic procedure
* Knowing Turkish language
* Agreeing to participate in the research voluntarily
* Parent and child not having a diagnosed neuropsychiatric disease
* Literacy of the child and parent
* Not having verbal communication barrier

Exclusion Criteria:

* Refusing to participate in the research
* Not knowing Turkish language
* Having a verbal communication barrier
* Parent and child have a diagnosed neuropsychiatric disease
* Illiteracy of the child or parent
Comparison of Nutritional Products for People With Type 2 Diabetes

Compare the glycemic and insulinemic responses of a standard nutritional product with two diabetes-specific nutritional products in patients with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

1. Subject states that he/she has type 2 diabetes (as evidenced by use of oral hypoglycemic medication for at least two months).
2. Subject is between 18 and 75 years of age, inclusive.
3. Subject is a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to screening visit.
4. If female is of childbearing potential, is practicing a method of birth control.
5. Subject's BMI is \> 18.5 kg/m2 and \< 35 kg/m2.
6. If on a chronic medication such as anti-hypertensive, lipid-lowering, thyroid medication or hormone therapy, subject has been on constant dosage for at least two months prior to screening visit.

Exclusion Criteria:

1. Subject uses exogenous insulin for glucose control.
2. Subject states that he/she has type 1 diabetes.
3. Subject states that he/she has a history of diabetic ketoacidosis.
4. Subject takes an alpha-glucosidase inhibitor.
5. Subject states that he/she has a current infection ; has had inpatient surgery, or corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks prior to screening visit.
6. Subject states that he/she has an active malignancy (excluding the following dermal malignancies: basal cell carcinoma, squamous cell carcinoma, carcinoma in-situ of the cervix).
7. Subject states that he/she has had a significant cardiovascular event ≤ six months prior to screening visit; or stated history of congestive heart failure.
8. Subject states that he/she has end stage organ failure or is status post organ transplant.
9. Subject states that he/she has a history of renal disease.
10. Subject states that he/she has current hepatic disease.
11. Subject states that he/she has a history of severe gastroparesis.
12. Subject states that he/she has a chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
13. Subject has taken/is currently taking any herbals, dietary supplements, or medications, other than oral hypoglycemic medications, during the past four weeks prior to screening visit that could profoundly affect blood glucose.
14. Subject states that he/she has clotting or bleeding disorders.
15. Subject is known to be allergic or intolerant to any ingredient found in the study products.
Indwelling Urinary Catheterization Versus Clean Intermittent Catheterization for the Short-term Management of Hospitalized Patients With Transient Acute Urinary Retention

Objective: Acute urinary retention (AUR) is a common problem in hospitalized patients. Either indwelling urethral catheterization or clean intermittent catheterization (CIC) can be the choice of treatment. In chronic urinary retention, most physicians prefer CIC to chronic indwelling urethral catheter on the basis of the claim that the rate of catheter-associated urinary tract infection (CAUTI) is lower.

Method: The patients were randomized into indwelling urethral catheter and CIC groups. The primary outcomes of the study were catheter-associated asymptomatic bacteriuria and CAUTI. The secondary outcomes were pain, hematuria, cloudy urine, and quality of life.

We queried the hospitalized patients in Ramathibodi Hospital who developed first-time AUR from June 2014 to May 2015. Patients under 18 years of age with a history of urinary retention, urinary tract infection, and poor compliance were excluded from this study. All the patients gave their written informed consents. The patients were randomly divided into two groups depending on the type of assigned intervention: CIC and indwelling urethral catheter groups.

All the patients were followed up after 2 weeks; urinalysis and urine culture were obtained at the time of AUR and whenever the patients developed UTI-associated symptoms. The patients with positive urine culture at the time of AUR were excluded from the study.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients in Ramathibodi Hospital who developed first-time AUR from June 2014 to May 2015.

Exclusion Criteria:

* Patients under 18 years of age
* History of urinary retention
* Urinary tract infection
* Poor compliance
Walking, Spontaneous Physical Activity and Lipid Oxidation After Dietary Treatment of Obesity

The purpose of this study is to determine whether walking exercise after dietary treatment of obesity is associated with a decrease of the daily spontaneous physical activity and\\or with an increase of the time spent in sedentary activities. Our hypothesis is that the practice of walking as an exercise during the phase of weight stability following the dietary treatment of obesity leads to a reduction of spontaneous physical activity and\\or to an increase in the time spent in sedentary activities.

The subjects of this study will be randomised in 2 groups:

A group with usual follow-up and a group with usual follow-up associated with recommendations to introduce a program of walking achieving gradually 2000-2500 kcal/week.

Eligibility Criteria:
Inclusion Criteria:

* Women from 18 to 50 year-old
* In phase of weight stability
* BMI\<40kg/m²

Exclusion Criteria:

* History of bariatric surgery
* Diabetes
* Suspicion of obstructive sleep apnea syndrome
Lactated Ringers vs Normal Saline in Patients With Acute Pancreatitis: A Bias-Adjusted Meta-analysis

This study aims to compare NS and LR in terms of outcomes in patients with acute pancreatitis while addressing the current methodological issues with available meta-analyses on the topic. Such comparison combined with bias adjustment will assist with identifying the optimal fluid rehydration therapy in acute pancreatitis, since most of the available data is conflicted around the topic. A database search will be conducted to identify studies comparing normal saline and ringer's lactate. Existing meta-analyses will be assessed. The results will be discussed in the light of their strengths and limitations and then any deficiencies will be addressed through a new synthesis as a final step of this umbrella review. The primary outcome will be SIRS at 24 hours. OR and 95% confidence intervals will be generated using the quality effects model. Heterogeneity will be evaluated using the I2 statistic. Publication bias will be assessed using the Doi Plot.


Eligibility Criteria:
Inclusion Criteria:

* RCTs and observational studies that compared NS vs LR in AP patients.
* Studies reviewed must report data as effect estimates or provide raw data sufficient to calculate effect estimates.

Exclusion Criteria:

* Studies involving animal studies, pediatric patient populations, and cell lines will be excluded.

All studies will be reviewed in full form by each author to determine eligibility. In case of disagreement, determination of inclusion will be reached via consensus.
Vital Signs-Integrated Patient-Assisted Intravenous Opioid Analgesia for Post Surgical Pain

To meet the unmet need of better and safer pain relief for acute pain in the post-operative setting, a Vital-signs-integrated Patient-assisted Intravenous opioid Analgesia ("VPIA") Delivery System, with novel and intelligent software algorithms and specialised hardware was developed. In the previous project, the investigators have shown that this system has the potential to increase the safety and patient satisfaction with intravenous opioid analgesia. However, opportunities to develop more robust vital signs monitoring with the goal of ensuring continual and effective analgesia are identified.

The primary aim of this proposal is to advance the development of technology (through new features and functionality) and perform clinical evaluation of the VPIA system with a larger sample size to show improvements in patient's satisfaction (pain relief) and robustness of system in terms of vital signs integration. Novel technology using adaptive vital signs controller, integrated with an infusion pump and single finger probe vital signs monitor system will be developed with the aim for commercialisation.

The investigators will conduct a prospective cohort study in 150 adult female subjects that undergo major surgery that require postoperative patient controlled morphine analgesia so as to examine the monitoring performance of oxygen desaturation, respiratory depression and patient satisfaction and user feedback.

Patients who are undergoing elective surgery with plan to use postoperative patient controlled analgesia with morphine will receive study information either at pre-operative assessment clinic or upon admission for surgery if they have not attended the pre-operative assessment clinic. They will be screened for eligibility using the inclusion and exclusion criteria. If eligible for recruitment, the patients will be approached by the investigators for recruitment. Upon successful recruitment of the study, patients will be asked to complete two questionnaires and rate their pre-surgical pain on the numerical rating scale in the pre-anaesthetic evaluation clinic. The general anaesthesia technique and type of analgesia administered intra-operatively will be according to standard practice and is at the discretion of the attending anaesthesiologist. After surgery, patients will be reviewed daily (up to 3 days) in the post-operative wards. They will be asked on questionnaire scoring, pain score, and analgesia information and adverse event, if any.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anaesthesiologist (ASA) physical status I-III;
* Age 21-70 years;
* Receiving patient controlled analgesia of morphine for postoperative analgesia.

Exclusion Criteria:

* Allergy to study drug;
* With significant respiratory disease and obstructive sleep apnea;
* Unwilling to place oxygen saturation and respiratory rate monitoring during study period;
* Unable to comprehend the use of patient controlled analgesia;
* Obstetric patients.
Safety and Efficacy of Intracoronary Ad5FGF-4 in Patients With Stable Angina

The purpose of this study is to determine whether a single intracoronary infusion of Ad5FGF-4 is effective in improving exercise capacity measured by exercise treadmill testing, angina functional class, patient symptoms, quality of life, and cardiovascular outcomes. To doses are to be studied, 2.87x10(8) and 2.87x10(9) viral particles, to evaluate the dose-response of Ad5FGF-4. Short-term and long-term safety of Ad5FGF-4 will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* CCS class II - IV, technically unsuitable for revascularization by CABG or PTCA able to exercise between 3 and 10 minutes on treadmill

Exclusion Criteria:

* Unstable angina, CCS class 1 angina optimal candidates for revascularization
DRA vs PRA for US-guided Radial Artery Catheterization in ICU

Patients were randomly divided into two groups: ultrasound-guided (US-guided) in-plane distal radial access (IP-DRA) and in-plane proximal radial access (IP-PRA) catheterization.

For IP-DRA , a linear transducer is placed in the radial fossa, which is known as the snuff-box. After obtaining a long-axis view of the radial artery ,the needle is inserted in the midpoint of the small footprint transducer. Then,the needle is advanced under real-time US guidance until visualizing the tip of the needle inside the artery .

For IP-PRA , a linear transducer is placed in the standard conventional forearm radial.

After obtaining a long-axis view of the radial artery ,the needle is inserted in the midpoint of the small footprint transducer. Then,the needle is advanced under real-time US guidance until visualizing the tip of the needle inside the artery .

\*Ultrasound-guided catheterization of the radial artery, by proximal approach:

* Patient's hand in hyperextension with slight dorsiflexion of the wrist.
* The placement of the ultrasound probe initially linear in order to obtain the "short axis" image of the artery; then a quarter turn until obtaining a longitudinal "long axis" view.
* The operator must identify the artery using the pulsed wave Doppler;
* Insertion of the needle in the middle of the transducer providing an "in plane" orientation. Thus the needle was advanced slowly and its tip was visualized throughout the procedure. \*Ultrasound-guided catheterization of the radial artery, by distal approach:
* If the right hand is along the body / if the left hand is on the trunk.
* The ultrasound probe placed at the level of the anatomical snuffbox by placing the transducer in a linear fashion then rotated coronally until a longitudinal image is obtained \*In the 2 groups: - The longitudinal "in plane" approach is used - After visualization of the penetration of the bevel of the needle into the lumen of the artery and the jet of arterial blood into the syringe on aspiration, a flexible metal guide was introduced into the artery through the trocar according to the Seldinger's method. - The correct positioning of the guide in the artery was then confirmed by ultrasound. Any obstacle preventing insertion of the guide system always led to a new puncture.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted in intensive care unit requiring a central venous catheter (CVC)

Exclusion Criteria:

* Patients with radial AV shunt for hemodialysis
* Patients with Renaud phenomenon or lymphedema
* Congenital or acquired deformity of arms
* Cannulation site infection, hematoma and surgery
Cost-effectiveness of Genotype Guided Treatment With Antiplatelet Drugs in STEMI Patients: Optimization of Treatment (POPular Genetics)

Rationale: the use of antiplatelet drugs (i.e. clopidogrel, ticagrelor or prasugrel) is crucial in the treatment of patients undergoing percutaneous coronary intervention (PCI) with stent implantation to prevent atherothrombotic events. Ticagrelor and prasugrel are more effective in preventing atherothrombotic events, but with a higher risk of bleeding complications, compared to clopidogrel. Clopidogrel is converted into its active metabolite by CYP2C19. Carriers of the non functional CYP2C19\*2 and \*3 alleles have an impaired CYP2C19 capacity, making clopidogrel less effective. For these subjects ticagrelor or prasugrel is an alternative.

Objective: to assess the efficacy, safety and cost-effectiveness of the CYP2C19 genotype guided antiplatelet treatment strategy, using clopidogrel in non-carriers of a CYP2C19\*2 or \*3 allele and ticagrelor or prasugrel in carriers of a CYP2C19\*2 or \*3 allele in STEMI patients.

Intervention: the intervention group will be genotyped for CYP2C19\*2 and \*3 allele variants within 48 hours after primary PCI. Carriers will receive either ticagrelor (90 mg twice daily) or prasugrel (10 mg once daily or 5 mg once daily if the patient is older than age 75 or has a body weight less than 60 kg), according to local standards. Non-carriers will be treated with clopidogrel (75 mg once daily). The control group receives either ticagrelor or prasugrel, according to local standards at the same dosage as the CYP2C19\*2 or \*3 carriers in the intervention group. The antiplatelet drug will be continued for one year after PCI. The follow-up duration will be one year using follow-up questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* more than 21 years of age with symptoms of acute myocardial infarction of more than 30 minutes but less than 12 hours
* performed primary PCI with stenting for STEMI

Exclusion Criteria:

* unable to give informed consent or have a life expectancy of less than one year
* active malignancy with increase in bleeding risk, in the investigator's opinion
* women who are known to be pregnant or who have given birth within the past 90 days or who are breastfeeding
* having received thrombolytic therapy within the previous 24 hours or oral anticoagulants during the previous 7 days
* severe renal function impairment needing dialysis
* confirmed or persistent severe hypertension (Systolic Blood Pressure (SBP) \> 180 mmHg and/or Diastolic Blood Pressure (DBP) \>110 mmHg) at randomization
* contraindication to anticoagulation or at increased bleeding risk, at the investigator's opinion
* cardiogenic shock (SBP ≤ 80mmHg for \>30 mins) or Intra-Aortic Balloon Pump (IABP) placed
* history of major surgery, severe trauma, fracture or organ biopsy within 90 days prior to randomisation
* clinically significant out of range values for platelet count or haemoglobin level at screening, in the investigator's opinion.
PEARL (PrEnAtal Enzyme Replacement Therapy for Lysosomal Storage Disorders)

For detailed information, please view our study website: https://pearltrial.ucsf.edu/

The investigators aims to determine the the maternal and fetal safety and feasibility of in utero fetal enzyme replacement therapy in fetuses with Lysosomal Storage Diseases.

Because fetuses with these LSDs are at increased risk of serious perinatal morbidity and mortality, particularly in the setting of Non-Immune Hydrops Fetalis (NIHF), the administration of the approved enzyme therapy in utero has the potential to significantly improve outcomes for affected fetuses. The perinatal death rate associated with NIHF ranges from 30 to 75%, so development of an in utero approach to treatment could be of significant benefit. The in utero period has been shown to be a time of relative fetal tolerance to immune stimuli, and this tolerance may lead to improved response to ERT in situations where postnatal initiation instead leads to antibody development and impaired response to treatment. It is also probable that in some cases, initiation of ERT in utero leads to improved neurodevelopmental outcomes if the replaced enzyme impacts the neurologic system during critical periods of development.

This is a phase 1 clinical trial to determine the safety and feasibility of fetal enzyme replacement therapy in fetuses with LSD

Eligibility Criteria:
Inclusion Criteria:

* Live male or female fetuses at 18 0/7 weeks to 34 6/7 weeks gestation
* Diagnosis of one of the 8 included LSDs in utero by genetic or enzymatic analyses performed on amniotic fluid, fetal blood, placental tissue, or other samples through chorionic villus sampling (CVS), amniocentesis, cordocentesis, cell free fetal DNA, or other procedures. In the event that parents are identified as genetic carriers for a LSD, diagnostic testing for the fetus would be performed to confirm the diagnosis
* Pregnant women age 18 years to 50 years, carrying a live male or female fetus at 18 0/7 weeks to 34 6/7 weeks gestation
* Identified through the above listed means to be carrying a fetus with an LSD.
* Ability to give written informed consent and comply with the requirements of the study.

Exclusion Criteria:

* Fetuses with a concurrent severe structural anomaly
* Fetuses with an additional pathogenic genetic variant not related to the underlying LSD that contribute a significant risk of morbidity or mortality.

Hydrops fetalis will not be an exclusion criterion because ERT has the possibility of significant benefit in this situation.

* Women with one or more significant comorbidities that would preclude fetal intervention including, but not limited to:

  1. inability to complete the procedure secondary to maternal body habitus or placental location
  2. significant cardiopulmonary disease
  3. mirror syndrome
  4. end organ failure
  5. altered mental status
  6. placental abruption
  7. active preterm labor
  8. preterm premature rupture of membranes.
* Mother will require therapeutic dosing of anticoagulation within 24 hours prior to or following the intervention.