cyrilzakka/clinical-trials huggingface dataset:
Healthy, Immunized Communities Study

This project aims to understand how improving vaccine education and awareness can impact the number of parents who vaccinate, or intend to vaccine, their middle school-aged children with age-appropriate vaccines, including human papillomavirus (HPV), meningitis (MCV) and tetanus, diphtheria, pertussis (TDap).

Vaccines are considered one of the greatest public health successes. Unfortunately, an increasing rate of parental resistance in recent years has led to a reemergence of vaccine-preventable diseases. This project seeks to determine the effect of a multi-tiered school and community-based approach to improving rates of parental intent to vaccinate for middle school-aged vaccinations including Human Papillomavirus (HPV), meningitis (MCV) and Tetanus, Diphtheria, Pertussis (TDap).

By randomizing participating schools, parents receiving the intervention participated in (1) a community-based event to raise parental awareness of the importance of vaccination and (2) a social marketing campaign targeting parents' attitudes and knowledge around vaccinations.

The Investigators hypothesized that participation in this study would increase parental intention to vaccinate. In addition, this study intended to improve rates of recommended vaccination among middle school-aged children, as measured through vaccine uptake information required for annual entry into Pennsylvania public schools.

The Penn State team brings a breadth of experience in pediatrics, community-engaged research, adolescent health, and engagement with schools.

Eligibility Criteria:
Inclusion Criteria

* 18 years or older
* Parents and guardians of children who attend a School District of Lancaster middle schools
* Individuals who read and understand English
* Individuals with an email address

Exclusion Criteria

* Individuals who are non-English speaking
* Parents/Guardians \<18 years or older who do not have children attending a middle school in the School District of Lancaster
* Individuals who do not have an email address
* Individuals who plan on moving out of the Lancaster City area in the next year
A Multicenter Phase 2 Study of CI-1040 in Patients With Advanced Nonsmall-Cell Lung, Breast, Colon and Pancreatic Cancer

CI-1040 is an experimental drug that is being tested in patients who have advanced colorectal and lung cancer who failed no more than one prior chemotherapy regimen, breast cancer who have failed no more than 2 prior regimens and in patients with pancreatic cancer who have received no prior chemotherapy. CI-1040 is taken orally twice daily with meals. Patients are required to have blood tests periodically while receiving treatment and will be monitored closely throughout the trial for possible side effects and for response.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are at least 18 years or older who have pathological or hiostological confirmation of colorectal, nonsmall cell lung cancer, breast, or pancreas cancer.
* No more than 1 prior chemo for lung or colon cancer, no more than 2 for breast no prior chemotherapy for pancreas cancer.
* Original or recent tumor tissue must be available.
* Patients must have been off prior chemoptherapy for 4 weeks and radiation for 3 weeks.
* Patients must have adequate renal, liver, and bone marrow function, not have serious infection or life-threatening illness (unrelated to tumor).
* Must be able to swallow capsules and not have gastrointestinal disorders that may affect absorption of the drug.

Exclusion Criteria:

* Unstable medical condition
* prior chemotherapy within 4 week of screening
* series infection
* other tumor types
* ECOG performance status of 3 or 4.
Indocyanine Green Lymphangiography in Identifying Thoracic Duct During Neck Surgery

This phase I trial studies how well indocyanine green lymphangiography works in identifying thoracic duct during neck surgery. Diagnostic procedures, such as near infrared fluorescence imaging with indocyanine green may help recognize and prevent injury to thoracic duct during neck surgery.

PRIMARY OBJECTIVES:

I. Feasibility and optimization of thoracic duct identification using indocyanine green (ICG) lymphangiography.

II. To explore specifically how identifying the thoracic duct (TD) will prevent injury intra-operatively.

III. To understand if a TD injury can be recognized by leakage of fluorescent chyle into the operating field.

OUTLINE:

Participants receive indocyanine green solution subcutaneously (SC) and undergo near-infrared imaging over 1-2 minutes during their standard of care neck surgery.

After completion of study treatment, participants are followed up for up to 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult patients who are undergoing LEFT modified radical or selective (including zone IV) lymph node dissection for any indication; this includes patients who have had prior neck surgery

Exclusion Criteria:

* Children, minors, pregnant women, women who are breast feeding, institutionalized patients
* Known prior allergic reaction to ICG or allergy to iodine
* Patients with excessively high anesthesia risks who cannot tolerate the extra time under general anesthesia needed to perform this study; the surgeon and anesthesiologist will determine this pre-operatively
Accuracy of Ultrasound for Detecting Residual Fragments During RIRS

The purpose of this study is to assess the accuracy of ultrasound and traditional fluoroscopy to find the residual fragments before retrograde intrarenal surgery is complete. This would ultimately limit the need for radiation exposure and improve the quality of clinical care given to patients and healthcare teams.

Ultrasound is currently gaining popularity as an alternative imaging modality for the diagnosis and treatment of urolithiasis. However, the benefit of ultrasound on the diagnostic accuracy of detecting residual fragments during retrograde intrarenal surgery (RIRS) has never been evaluated in a randomized study. Its use would reduce radiation exposure for patients and care team members as well as improve stone free clearance rates for surgery. Therefore, The investigators plan to conduct a randomized trial to assess the diagnostic accuracy of ultrasound and fluoroscopy in conjunction with endoscopic examination for detecting residual stone fragments during retrograde intrarenal surgery. After admission, approximately 172 subjects will be randomized in a 1:1 ratio to receive ultrasound or fluoroscopy before completing RIRS. Subsequently, four weeks after the operation, the investigators will compare with routine low-dose non-contrast computed tomography as a gold standard for detecting residual fragments. If ultrasound is more accurate than fluoroscopy in detecting residual fragments, the investigators will encourage this approach as it can reduce radiation exposure for patients and healthcare professionals.

Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 18.
* Consecutive patients with a diagnosis of renal stone or ureteral stone with a plan to undergoing RIRS for stone removal.

Exclusion Criteria:

* Patients who decline informed consent.
* Pregnancy
* Kidney transplantation
* Ectopic kidney
* Patients undergoing concurrent bilateral stone removal surgery.
* Patients whose pain cannot be controlled when presenting at the Emergency Department.
Mental Practice on Balance

The main objective of this research is to see the effect of two mental practice techniques on static and dynamic balance.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 60
* Healthy and with no pain subjects

Exclusion Criteria:

* Any cognitive impairment that hindered viewing of audiovisual material.
* Difficulty understanding or communicating.
* Presence of systemic pathology, Central Nervous System or rheumatic disease.
* Inadequate understanding of the Spanish language to follow instructions for measuring and treatment.
* Collaboration of pregnant women.
* Underage subjects
* Subjects with pain at the time of the study.
Pain Management at Latent Period of Labour

Examine the effectiveness of an analgesic in PERFALGAN maternity latent phase of labor.

Examine the safety in PERFALGAN in the mother and the newborn in terms of the level of drug in blood

Maternity are latent or first stage of labor and complained of pain at the level of 4 or higher on a scale VAS, and are not in risk (HIGH RISK). And did not receive analgesics within 4 hours.

The sample will consist of at least 100 women in labor.

1. women, will be identified in the reception room of a delivery room by midwives.
2. The research team will ask for consent after receiving an explanation and confirmation of understanding.
3. The midwife will perform and will record pain assessment by visual analog scores .
4. Maternity reported pain level 4 and above will be asked four questions out of data collection and offered them treatment I.V. PARACETAMOL 1gr as directed by the physician.
5. After giving I.V. PARACETAMOL 1g, carried out and documented estimate of the pain returns (by visual analog scores) after an hour wait at any time to wait four hours and two hours after birth.

   In cases of an outbreak of pain can give one of the following:

   Option A:

   Another portion of the I.V. PARACETAMOL 1gr within 4-6 hours the previous dose. The maximum daily dose of 4 grams.

   Option B:

   N2O by procedure

   A third possibility:

   Epidural physician approval
6. At the end of the birth fetal blood sample taken from the placenta for testing the level of paracetamol.
7. At the end of a blood sample taken birth for the client in liver function tests.
8. Interview woman with postpartum questionnaire will be made during her stay in the maternity ward.

Filling out a questionnaire that includes demographic data and about the process of birth, medical records.

Eligibility Criteria:
Inclusion Criteria:

* latent phase of labour
* low risk

Exclusion Criteria:

* high risk
* allergy to paracetamol
* liver insufficiency
Clinical Data Collection on Perceval S Sutureless Prosthetic Aortic Valve in the Chinese Population

The objective of the study is to evaluate the safety information on the Perceval S sutureless prosthetic heart valve after the implantation for aortic valve disease.

The study is designed as a post-market, observational, non-interventional retrospective and prospective registry.

In order to monitor the ongoing safety of the Perceval S as part of regulatory requirements, the study aims to retrospectively collect safety outcomes and performance data in patients with aortic valve disease implanted with Perceval S since 2022. The data will be used for regulatory purposes, to support the re-certification of the valve in the Chinese market.

Serious Adverse Events (SAEs) such as valve-related death, structural valve deterioration, cerebral thromboembolism, stroke, Transient Ischemic Attack, non-cerebral thromboembolism, major bleeding, re-operation will be studied to describe the safety profile of the valve.

Hemodynamic data from site reported echocardiography finding (mean gradient, peak gradient, effective orifice area, effective orifice area indexed, incidence and degree of PVL and central leak) at hospital discharge will also be evaluated. Data of approximately 80 subjects will be collected in four clinical sites in China.

Eligibility Criteria:
Inclusion Criteria:

1. Subject who has been implanted with Perceval S sutureless aortic heart valve
2. Subject (legal representative or family member) who has signed the approved informed consent or would provide verbal informed consent/ signed and dated informed consent, and available medical information

Exclusion Criteria:

1. Subject (legal representative or family member) who do not provide consent to the data collection
Randomized Pilot Study Evaluating Isopropyl Alcohol and UVC Rays in Disinfection of Cell Phones

Cell phones have become a fundamental accessory of our lives and clinical practice, often kept in contact with the body. Since most modern smartphones are equipped with touch screens, they can serve the function of reservoirs for pathogenic microorganisms; moreover, they can be the means of transmission of such microorganisms from the environment to humans.

A number of observational studies are available in the literature evaluating the effectiveness of various sanitization methods in reducing the bacterial load of high-touch devices, both chemical and physical.

To our knowledge, no real-world evidence is available comparing the residual effect of the two methods on the bacterial load of cell phones, since all available studies are carried out in the laboratory, with inoculums of predetermined bacterial loads whose suppression by the disinfectant is monitored over time, and involve laptops, tablets and keyboards.


Eligibility Criteria:
Inclusion Criteria:

* Be a healthcare provider in the departments of Neonatology, Geriatric Internal Medicine, Nephrology, Anesthesia, Resuscitation, Intensive Care Unit at Fondazione Policlinico Universitario "A.Gemelli" IRCCS
* Own a smartphone
* Carry one's smartphone for the duration of the work shift (8 hours)
* Give consent to participate in the study
* Be willing to report 3 hours after sanitisation for follow-up sampling

Exclusion Criteria:

* Not to be a healthcare worker in the departments of Neonatology, Geriatric Internal Medicine, Nephrology, Anesthesia, Resuscitation, Intensive Care Unit at Fondazione Policlinico Universitario "A.Gemelli" IRCCS
* Not to be on work shift during surveys
* Not to carry one's smartphone for the duration of the work shift (8 hours)
* Not to give consent to participate in the study
* Not to be willing to report 3 hours after sanitisation for follow-up sampling
Hydrocortisone Per-treatment Decrease Side Effects of Protamine Sulfate

This study aims to compare the hemodynamic parameters within and between patients who received Protamine Sulfate (PS) with Hydrocortisone (HC) vs. Protamine Sulfate alone during cardiac surgeries.

the investigators hypothesized that patients received PS along with HC would have different results in intraoperative hemodynamic changes of the blood pressure - both Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Mean Arterial Pressure (MAP) reading. Differences would also be expected for Heart rate (HR), Airway pressure and the usage of Adrenaline, Noradrenaline and Dobutamine.

Patients who had cardiac surgery using cardiopulmonary bypass were screened and enrolled from 4/7/2019 to 30/4/2020. Inclusion criteria for patients were normal preoperative hemoglobin level, normal preoperative platelet count, no known defect of the coagulation system, and patients with unimpaired renal function (creatinine clearance \< 30 ml/kg/min). The patients were excluded if they were younger than 18 years, patients with known defect of the coagulation system, renal impairment, previous vasectomy, allergy to fish or unable to give consent form.

The study carried out as a parallel-group, randomized, controlled trial with a 1:1 allocation ratio. Patients were screened for eligibility in the wards before being invited to participate in the research. After the invitation, the study was explained to patients. Those who agreed to participate in the study were asked to sign the consent form.

Eligibility Criteria:
Inclusion Criteria:

* Patients who had cardiac surgery using cardiopulmonary bypass
* Normal preoperative hemoglobin level
* Normal preoperative platelet count
* No known defect of the coagulation system
* Patients with unimpaired renal function (creatinine clearance \< 30 ml/kg/min)

Exclusion Criteria:

* Patients younger than 18 years
* Patients with known defect of the coagulation system
* Renal impairment
* Previous vasectomy
* Allergy to fish
* Unable to give consent form
A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Obese Adult Patients With Schizophrenia While Taking Antipsychotic Medications (GRATITUDE II)

This Phase 2, double-blind, placebo-controlled, randomized study is to assess the safety, efficacy, and pharmacokinetics (PK) of miricorilant (CORT118335) in obese patients with schizophrenia treated with antipsychotic medications.

This is a randomized, double-blind, placebo-controlled study that will assess the safety, efficacy, and PK of miricorilant in obese patients with schizophrenia who are currently taking olanzapine, risperidone, paliperidone, or quetiapine.

Patients who meet the criteria for the Study CORT118335-877 will be randomized on Day 1 to receive 600 mg miricorilant, 900 mg miricorilant, or placebo for 26 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of schizophrenia
* Are currently taking olanzapine, risperidone, paliperidone, or quetiapine and have gained weight from treatment while on these medications
* Must be on a stable dose of medication for 1 month prior to Screening
* Have a BMI ≥30 kg/m\^2.

Exclusion Criteria:

* Have a history of a medical condition affecting body weight (eg, poorly controlled hyper- or hypothyroidism; eating disorder such as anorexia, bulimia, or binge eating; or polycystic ovary syndrome)
* Have poorly controlled diabetes mellitus
* Have poorly controlled hypertension
* Have a history of symptomatic hypotension
* Have a history of orthostatic hypotension
* Have a history of a seizure disorder.
Pediatric and Adult Cerebral Arteriovenous Malformation Neurofunctional Outcomes

Cerebral Arteriovenous malformations (AVMs) are abnormal tangles which are usually believed congenital. AVM can cause different symptoms depending on where it is located, but the most common symptoms are intracranial hemorrhage and seizure. Outcomes of AVM patients can be very different due to factors like the location of lesion, age, sex etc. Generally, more early the intervention was taken, the risk of adverse events would be lower. But the selection of surgical timing for pediatric AVM patients is hard to judge, due to children's cerebral vessels angioarchitecture can be still developing with their age. Some previous studies indicated that there is no difference in intervention outcomes between pediatric and adult AVM patients, so pediatric patients should undergo more aggressive intervention. DOPA study aims to compare the clinical intervention outcomes of both pediatric and adult patients with eloquent region cerebral arteriovenous malformations, helping to determine the treatment strategy.

Follow-up: In the investigators' neurosurgical center, follow-up was conducted for all participants at the first 3-6 months and annually after discharge by clinical visit and telephone interview.

Study overview: DOPA will aim on outcomes of both pediatric and adult AVMs patients who underwent intervention in investigators' institution. Intervention strategies contains microsurgical resection, embolization, embolization + radiosurgery, and single-stage hybrid surgery (embolization + resection). Outcomes will be measured by a neurologist using Modified Rankin Scale (mRs). Participants' mRs\<2 will be considered as a good outcome and investigators will keep follow-up with every patient for at least 3 years.

Sample size: About 300 patients will be enrolled in this study, and adults and children will account for half. All kinds of intervention will be included. The distribution of different strategies is excepted as: 30% resection, 20% embolization, 30% embolization + radiosurgery and 20% hybrid surgery.

Study endpoints: The patients' mRs, occlusion rate and complication will be evaluated at 2 weeks, discharge from hospital, 1 year and 3 years after the first-time intervention.

Eligibility Criteria:
Inclusion Criteria:

* The diagnosis of AVM was confirmed with digital subtraction angiography (DSA) and/or magnetic resonance imaging(MRI).
* Patients had underwent interventions in our institution.
* AVMs were located in eloquent area.

Exclusion Criteria:

* Patients with multiple AVMs.
* Patients with hereditary hemorrhagic telangiectasia (HHT).
* Patients with missing clinical and imaging data.
Tamsulosin Assisted Ureteral Access Sheath Insertion

Aim is to study if 1 week of pre operative tamsulosin would enable easier insertion of ureteral access sheath in primary retrograde intrarenal surgery for renal stone disease


Eligibility Criteria:
Inclusion Criteria:

* renal stone undergoing retrograde intrarenal surgery

Exclusion Criteria:

* not on tamsulosin or other alpha blockers regularly
* ureteral stricture
* concurrent ureteric stone
Expression of Molecular Markers Before and After Neo-adjuvant Chemoradiotherapy in Rectal Cancer

The purpose of this study is to determine whether markers on tumor tissue may be an indicator for good response to neoadjuvant chemoradiotherapy in patients with rectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* locally advanced rectal cancer uT3 or uT4
* no distant metastasis
* neoadjuvant radiochemotherapy required

Exclusion Criteria:

* rejection of radiochemotherapy
Carbon Dioxide During Screening Unsedated Colonoscopy

Colonoscopy is currently most effective procedure used for detecting colon cancer especially in the early stages. Screening colonoscopies are performed in the symptom-free patients at risk of familial colon cancer. During colonoscopy air commonly used to insufflate the bowel may be retained after the procedure causing pain and discomfort to the patients. One of the methods used to reduce pain and discomfort is insufflation of carbon dioxide (CO2) instead of air during colonoscopy.

Aim of the study is evaluation of the use of carbon dioxide insufflation during colonoscopy.

The study was conducted in 200 consecutive patients undergoing screening colonoscopies for the detection of early colon cancer. The examinations were performed with Olympus 165 colonoscopes by seven experienced endoscopists, each of whom performed alone about over 2000 colonoscopies. The patients were randomly assigned to Group I and II with either air or carbon dioxide insufflation. Both study groups were matched by sex, age, duration of the procedure, and BMI. The authors compared for the duration of the procedure, coecal intubation time, complication rate, pulse rates immediately after the procedure, 15 minutes after, and subjective pain evaluation on a Visual Analogue Scale.

Eligibility Criteria:
Inclusion Criteria:

* age 50 yo and more
* no previous large bowel operations
* no previous colonoscopy
* informed consent

Exclusion Criteria:

* previous colonoscopy
* previous large bowel operations/ polypectomies