cyrilzakka/clinical-trials huggingface dataset:
A Post Marking Study to Evaluate the Safety of FluMist in Children

To assess the safety of FluMist vaccination

* To assess the safety of FluMist vaccination Rates of medically attended events in FluMist recipients, including serious adverse events (SAEs), anaphylaxis , urticaria, asthma, wheezing, pre-specified grouped diagnoses, and rare events potentially related to wild-type influenza, will be compared to rates in multiple non-randomized control groups.
* To assess the safety of annual FluMist re-vaccination \[Rates of MAEs in the subset of children who receive FluMist in ≥2 consecutive years will be compared to rates in first-time vaccinees during the same season.\]
* To assess the safety of FluMist vaccination in children previously vaccinated with trivalent inactivated influenza vaccine (TIV) \[Rates of MAEs in the subset of children who received one or more prior TIV vaccinations will be compared to rates in children who did not receive prior TIV.\]

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Age: born within the same calendar quarter as the reference FluMist vaccinee.

Exclusion Criteria:

* Children who have evidence of medical conditions that put them at high risk for complications of influenza (e.g., chronic cardiovascular and pulmonary disease) will be excluded from this control group.
FLT-PET Imaging of Brain Tumors in Children

Brain tumors are the leading cause of death from solid tumors in children. Tumor imaging is important in the management of these tumors, but current imaging methods have limitations in providing the necessary information for optimal treatment of these patients. The goal of this study is to evaluate the potential utility of positron emission tomography (PET) with 3'-deoxy-3'-\[F-18\] fluorothymidine (18F-FLT) in the medical management of brain tumors in children. Funding source - FDA Office of Orphan Product Development (OOPD)

Although pediatric central nervous system tumors are rare, they are a significant contributor to morbidity and mortality in children. Tumor staging, detecting recurrent tumor, and assessing the response to therapy are critical in the treatment of brain tumors, but current imaging methods have major limitations in providing such information. The objective of this study is to validate 3'-deoxy-3'-\[F-18\] fluorothymidine (18F-FLT) as a measure of tumor proliferation and to demonstrate the utility of 18F-FLT as a PET imaging agent in children with central nervous system tumors. The proposed studies will evaluate 18F-FLT PET in three groups:

1. Children with a new diagnosis of central nervous system tumor.
2. Children in whom conventional imaging has raised concern for possible recurrence of a central nervous system tumor.
3. Children receiving post-operative chemotherapy for a central nervous system tumor.

In these three groups, correlation of 18F-FLT uptake with tumor histopathology and patient outcome will be used to assess the utility of 18F-FLT for grading tumors at diagnosis, for accurate identification of tumor recurrence, and for early assessment of the response to chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* age 21 years or less
* capable of achieving imaging without need for sedation or anesthesia (typically age 8 years or greater, but there is no lower limit for age for eligibility)
* Karnofsky Performance Status of 50 or greater in subjects age 12 years or greater, for age less than 12 years a Lansky play scale of 50% or greater
* Patients receiving steroids and/or anti-seizure medications are eligible

Exclusion Criteria:

* clinically active infection
* pregnancy or breast-feeding
* serious intercurrent medical illness
* require emergency surgical intervention that would be inappropriately delayed by FLT-PET imaging
Dilapan-S / Dilasoft E-Registry in Induced Abortion

International Observational E-Registry on the use of osmotic dilators DILAPAN-S® / DILASOFT® for cervical priming prior to induced abortion.

International, multicentre, non-interventional, observational e-registry, post market clinical follow up study to document current clinical use of Dilapan-S or Dilasoft for cervical priming before induced abortion with regard to the number of dilators used, duration of insertion of dilators in situ and unusual complications consequent of their use.

Eligibility Criteria:
Inclusion Criteria:

* Intrauterine pregnancy ≥ 6 and ≤ 24 weeks gestation
* Patients who are capable of giving consent and sign the form
* Abortion being made in compliance with the Abortion Act 1967 (For England, Wales and Scotland)

Exclusion Criteria:

* Clinical signs of uterine, vaginal or vulvar infection
* Acute bleeding
Post-marketing Surveillance Study With GSK Biologicals' Pneumococcal Vaccine in Healthy Infants in Philippines

The purpose of this post-marketing surveillance study is to evaluate the safety of Synflorix™ when administered according to the local Prescribing Information to healthy Filipino infants.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that their parents/Legally Acceptable Representative(s) (LAR(s)) can and will comply with the requirements of the protocol.
* Filipino male or female subjects whose age at the first vaccination with Synflorix™ in this PMS should not be less than 6 weeks of age.
* Filipino male or female subjects who enter the PMS at the second dose should not be less than 10 weeks of age.
* Filipino male or female subjects who enter the PMS at the third dose should not be less than 14 weeks of age.
* Filipino male or female subjects who enter the PMS at the booster dose (i.e. if they have received Synflorix™ in the previous dose/s outside the PMS) should not be less than 10 months of age. The time interval between the primary vaccination and booster dose should be at least 6 months. For the booster dose, subjects who received PCV-7/-13 or Synflorix™ in their primary vaccination series will be allowed to take part in the PMS.
* Written and signed informed consent obtained from the parents/LAR(s) of the child. Where parents/LAR(s) are illiterate, the consent form will be countersigned by a witness.
* Free of obvious health problems as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

* Acute disease and/or fever at the time of vaccine administration.
* Fever is defined as temperature ≥ 37.5°C (99.5°F) on axillary, infrared or tympanic setting.
* Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
* History of chronic condition(s) requiring treatment such as cancer or autoimmune diseases.
* Hypersensitivity to latex (found in syringe-tip cap and plunger).
* Any contraindications as stated in the Prescribing Information.
Glymphatic Kinetics In Healthy Adult Volunteers

This study is being done in order to see how gadolinium-based MRI contrast (Magnevist) travels through the central nervous system (CNS) when injected through the spinal column, and to compare differences between two age groups (age 20-50, and 51-80). This will allow investigators to evaluate how much contrast has crossed into the tissue surrounding the brain. Such information will help investigators determine whether this kind of contrast can be used to model how other drugs might travel through the CNS and evaluate its use as an illustrative imaging marker that mirrors the glymphatic system.

This is a prospective, longitudinal study of MR imaging of intrathecally delivered gadolinium contrast (Magnevist, Gd-DTPA) in healthy adult male and female subjects. Subjects will be divided into two groups (20-50 years old and 51-80 years old) both of which will receive intrathecal injection of the drug Magnevist (Gd-DTPA), followed by serial MR imaging over the course of 10-12 hours. The purpose of the study is determine the transport kinetics of Central Nervous System (CNS) exposure to gadolinium contrast injected into the lumbar intrathecal space (lower back) and evaluate changes with age. This will allow investigators to evaluate the brain parenchymal penetration of gadolinium as an illustrative imaging marker that mirrors the glymphatic system. Investigators hypothesize the exposure and penetration patterns of the neuraxis to neurotherapeutic drugs can be modeled using gadolinium intrathecal contrast administered in the lumbar intrathecal space.

Eligibility Criteria:
Inclusion Criteria:

1. Deemed healthy and able to undergo MR imaging by the Site Investigator, based on screening assessments:

   medical history, physical examination, vital signs, and clinical laboratory values
2. Age 20-80
3. Willing to undergo multiple imaging sessions
4. Normal screening MRI to exclude subjects with a mass (e.g., disk herniation), congenital malformation (e.g., Chiari malformation), or an abnormal curvature of the spine that could alter CSF flow.
5. If female of childbearing age: negative pregnancy test
6. Normal Basic metabolic Panel and CBC (Platelet count \> 150,000; Hb \>8)
7. Willing to undergo LP procedure. -

Exclusion Criteria:

1. Kyphosis
2. Claustrophobia
3. Chronic cough
4. Active infection with fever (\>101.5), to limit risk of meningitis. Infections could include pneumonia, pharyngitis, skin infection, UTI, etc.
5. History of CNS tumor or anomaly
6. History of radiation therapy to the CNS
7. History of hydrocephalus
8. Abnormality on MRI that could impede CSF flow (i.e., extruded disk)
9. Laboratory finding of prolonged coagulation times
10. Pregnant/nursing
11. Prior spine or brain surgery or trauma
12. Inability to lay still and supine
13. Recent lumbar puncture within 1 month of planned LP.
Antithrombin to Improve Thromboprophylaxis and Reduce the Incidence of Trauma-Related Venous Thromboembolism

The purpose of this study is to determine if additional interventions will assist with decreasing the risk and/or severity of thromboembolism (clotting complications) in patients who have experienced a major traumatic event.


Eligibility Criteria:
Inclusion Criteria:

* Highest level of trauma activation or upgrade to highest level
* Polytraumatic injuries OR pelvic/long bone fracture
* Admission to trauma ICU or Surgical Intermediate Care Unit (SIMU)
* Informed consent obtained

Exclusion Criteria:

* Prisoners (defined as those directly admitted from correctional facility)
* Known or suspected pregnancy
* ≥ 20% total body surface area (TBSA) burned
* Nonsurvivable head injuries
* Known hematologic or immunologic disorders
* Known prehospital anticoagulant use
* Patients initially placed on unfractionated heparin for thromboprophylaxis
* Known allergy to Antithrombin or it's components
* Enrollment in another interventional study unless approved by Trial Principal Investigator
Botox for Chronic Pelvic Pain

The purpose of this research study is to find out if precise, targeted injection of botulinum neurotoxin (commonly known as Botox) provides better relief of pelvic floor hypertonicity and pain than the standard method being used. The researchers want to better understand the effects (good and bad) of targeted botulinum neurotoxin injections in women with pelvic floor disorders.


Eligibility Criteria:
Inclusion Criteria:

1. Females between 18 and 60 years of age
2. Clinical diagnosis of interstitial cystitis/bladder pain symptoms
3. Complaints of pain, pressure, or discomfort in the bladder and/or pelvic area for the past 6 months or more, associated with lower urinary tract symptoms (such as frequency of urination), in the absence of other explanation of the symptoms (e.g., UTI) \*
4. Myofascial pain diagnosed with palpable bands or nodules of contracted muscle fibers
5. Pelvic muscle tenderness by assessment of pelvic floor muscles on digital pelvic examination
6. No botulinum neurotoxin pelvic floor muscle injection treatment within 6 months prior to recruitment
7. Able to provide informed consent

Exclusion Criteria:

1. Males
2. Women \< 18 and \> 60 years of age
3. History of pelvic malignancy and sexual transmitted diseases that is currently not in remission
4. Bleeding disorder such as coagulopathy
5. Hypersensitivity to botulinum neurotoxin
6. Received botulinum neurotoxin pelvic floor muscle injection within 6 months prior to recruitment
7. History of neurological disorders, such as spinal cord injury, multiple sclerosis, amyotrophic lateral sclerosis or myasthenia gravis
8. Pregnancy, breast feeding or planning to get pregnant within one year after the last botulinum neurotoxin injection.
Disposable Powered Articulating Linear Cutter Stapler in Total-Thoracoscopic Anatomic Lobectomy (Segmentectomy)

To evaluate whether the anastomosis success rate of the main effectiveness evaluation indexes is not inferior to the similar products produced by Johnson \& Johnson when the Fengh Disposable Powered Articulating Endoscopic Linear Cutter Stapler Used for Thoracoscopic Anatomic Lobectomy (segmentectomy)

By comparing the effectiveness and safety of the disposable electric-endoscopic linear cutter stapler and cartridge (the subject product) produced by Jiangsu Fengh Medical Co., Ltd. and the similar product (electric-endoscopic linear cutter stapler with articulating head) produced by Johnson \& Johnson in total-thoracoscopic anatomic lobectomy (segmentectomy), to prove that the subject product can be used for pulmonary tissue resection and anastomosis, and that the clinical trial meets the requirements of Good Clinical Practice for Medical Devices, Guidelines for Clinical Trial Design of Medical Devices and Guidelines for Technical Review of Endoscopic Stapler Registration, which can be used for product registration application.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects aged 18-70 (inclusive), with no gender limitation;
2. The subject plans to undergo thoracoscopic anatomic pulmonary lobectomy (pulmonary segment);
3. Subjects or their guardians can understand the purpose of the study, show sufficient compliance with the study protocol, and sign the informed consent.

Exclusion Criteria:

1. Subjects have contraindications of video-assisted thoracoscopy;
2. The preoperative imaging results of the subjects indicated the presence of severe pleural adhesion and significant calcified hilar lymph nodes;
3. Subjects' platelet (PLT) \<60x 10%/L or INR \> 1.5;
4. Subjects forced expiratory volume in 1 second (FEV1)/expected value ≤50%, or forced expiratory volume in 1 second (FEV1)/use Vital capacity (FVC)≤60%;
5. Cardiac ejection fraction ≤50%;
6. Major organ failure or other serious diseases (including clinically relevant cardiovascular diseases or within 12 months prior to enrollment) Myocardial infarction; A history of severe neurological or psychiatric illness; The presence of a serious infection before surgery that must be controlled with medication; Dissemination of activity Sexual intravascular coagulation; At high risk of blood clots);
7. The subject is a pregnant or lactating woman;
8. The subject participated in clinical trials of other drugs or devices within 1 month prior to the trial;
9. Other conditions that the researcher judged inappropriate for inclusion. .
Platelet Transfusion in Sepsis Trial

Platelets are important mediators of an inflammatory response and a key component of the innate immune system to defend the human body against invading pathogens. However, little evidence exists regarding the number of platelets that should be used als transfusion threshold in septic patients. In this trial platelet transfusion will be performed with either \<50000/µl or \<20000/µl as a trigger.


Eligibility Criteria:
Inclusion Criteria:

* Sepsis defined as alteration of SOFA score (Sepsis-related organ failure assessment score) \>2 points (Sepsis-3 definition)
* platelet count \<50.000/µl

Exclusion Criteria:

* Age less than 18 years
* patients with immune thrombocytopenia
* major bleeding in the last 72 hours or ongoing major bleeding
* patient, surrogate or physician not committed to full intensive care support
* pregnancy
Improving Decision-Making for Low Health Literate Prostate CA Patients

This study used a randomized controlled trial to evaluate whether Healium (designed to target preference elicitation) is as efficacious as Healing Choices (a comprehensive education and decision tool) in improving outcomes for decision-making and emotional quality of life.

Background: Elicitation of patients' preferences is an integral part of shared decision making, the recommended approach for prostate cancer decision making. However, existing decision aids for this population do not specifically focus on patients' preferences. Healium is a brief interactive web-based decision aid that aims to elicit patient's treatment preferences and is designed for a low health literate population. This study used a randomized controlled trial to evaluate whether Healium (designed to target preference elicitation) is as efficacious as Healing Choices (a comprehensive education and decision tool) in improving outcomes for decision-making and emotional quality of life.

Method: Patients diagnosed with localized prostate cancer who had not yet made a treatment decision were randomly assigned to the brief Healium intervention or Healing Choices, an extensive decision aid previously developed by our group that serves as a virtual information center on prostate cancer diagnosis and treatment. Assessments were completed at baseline, 6-weeks and 3-months post-baseline, and included decisional outcomes (decisional conflict, satisfaction with decision, preparation for decision-making), and emotional quality of life (anxiety/tension and depression), along with demographics, comorbidities, and health literacy.

Eligibility Criteria:
Inclusion Criteria:

* a diagnosis of localized prostate cancer and eligible for all treatment options (ie., surgery, radiation, active surveillance);
* had not yet made a treatment decision or begun treatment; and
* have basic proficiency (grade school level) in reading English.

Exclusion Criteria:

• none
Analysis of Injury Risk Factors in Elite Athletes

Background information. The different disciplines of athletics place high physical demands on athletes. These different categories of running vary in terms of physical effort and duration, generating different levels of risk of injury. The description of the main injuries that affect elite athletes in the different athletics disciplines, as well as the identification of the specific risk factors of each discipline, will allow the identification of preventive measures to be implemented.

Objective. To identify the risk factors for tendon injury in professional long- and middle-distance athletes, according to the type of event, and to identify the best predictive model for tendon injuries based on anthropometric and athletic variables.

Method. Ambispective cohort study. 81 elite athletes will be recruited. The primary variable will be the number of tendon injuries in the last three seasons. The secondary and modifying variables will be: age (in completed years), weekly training load (in minutes), type of footwear (sneakers without carbon plate, sneakers with carbon plate, spiked sneakers without carbon plate and spiked sneakers with carbon plate), diet (balanced, high in carbohydrates, high-protein, controlled hypocaloric and adapted to the training cycle) and the regular practice of another physical activity. The possible confounding variables will be the body mass index, the date of tendon injuries in that period and the time spent as a federated athlete (in completed months). The analysis will calculate the risk of injury in these athletes and assess the influence of confounding factors and trend analysis on the primary variable, stratified by possible confounding factors.

Expected results. To calculate the risk of injury in elite athletes based on anthropometric and sociodemographic variables. To identify the predictive model of tendon injuries in elite athletes


Eligibility Criteria:
Inclusion Criteria:

* Elite federated athletes
* Who have not undergone previous musculoskeletal surgery in the seasons under study
* Who were federated at least one year before the study period
* Sign the informed consent document.

Exclusion Criteria:

* Athletes who have not participated in competition, during the study seasons, for a period of more than 6 months due to a musculoskeletal injury
Stop Vasodepressor Drugs in Reflex Syncope

Investigate clinical effects (reduction of number of syncope and associate symptoms) of suspension of vasoactive drugs in patients affected by vasodepressor reflex syncope.

Several drugs which are commonly used in clinical practice, such as antihypertensive, antiarrhythmic and psychiatric drugs, are associated with orthostatic hypotension and syncope. This phenomenon is much more evident in the elderly and with multiple therapies. The present study was aimed to investigate, in patients affected by reflex syncope, the clinical effects (reduction in syncope recurrence and associated symptoms) and the laboratory tests (negativization of carotid sinus massage and tilt table test) when such drugs are discontinued or reduced

Eligibility Criteria:
Inclusion Criteria:

Patients assuming chronic (\>1 year) vasoactive therapy affected by reflex recurrent (\>2 episodes) syncopes who have a positive dominant vasodepressor or mixed response to tilt table test and/or carotid sinus massage

Exclusion Criteria:

1. Orthostatic hypotension defined as fall in systolic blood pressure \>20 mmHg during the first 3 minutes of active standing
2. Competing diagnosis of syncope different from hypotensive reflex syncope
3. Reflex syncope with negative response to carotid sinus massage and tilt table test
4. Cardioinhibitory reflex syncope which requires permanent cardiac pacing
5. Severe hypertension which requires treatment (\>150/95)
6. Structured heart disease which requires hypotensive therapy in order to prevent acute heart failure
7. Cardiac hypotensive therapy in order to prevent recurrences
8. Previous stroke or transient ischemic attacks
ProofPrincip IntraTu TCells SinglDoseImmunCheckpoinInhib Gastro-Esophage Adenocarcinoma W/ARID1a Mu

This is a proof of principle clinical trial determining efficacy of single dose dualimmune checkpoint inhibitors to increase intra-tumoral T cells in esophageal, gastroesophageal junction, and gastric adenocarcinomas. These are subjects who have not previously been treated for their disease, who are willing to undergo biopsy procedures, who's disease has not spread to other parts of the body, who's tumors have ARID1A mutations.


Eligibility Criteria:
Inclusion Criteria:

* Non metastatic GEC including locally advanced unresectable
* Treatment naïve
* Histologically proven adenocarcinoma of the esophagus or the stomach with ARID1a mutation either by liquid biopsy (ctDNA) or tissue NGS/WES
* MSI-Stable or pMMR
* Age ≥ 18 years
* Body weight \> 66 pounds
* ECOG ≤ 2
* Repeat biopsy feasible
* No clinically significant autoimmune disease

Exclusion Criteria:

* Patients with known metastatic disease
* Prior systemic treatment for esophagus, GEJ, or the stomach adenocarcinoma
* Patients with uncontrolled autoimmune disease per investigator discretion
* Inability or refusal to undergo biopsy procedures to obtain tissue samples