cyrilzakka/clinical-trials huggingface dataset:
Screening Brain MRI in High School Football: Does the Guardian Cap Reduce the Risk of Traumatic Brain Injury

Screening Brain magnetic resonance imaging (MRI) with Fluid-attenuated Inversion Recovery (FLAIR) and Susceptibility Weighted Imaging (SWI) sequences will be performed pre and post season on high school football players. One set of players will wear the Guardian Cap on their five star rated helmets and the other will wear five star rated helmets only. The investigators will compare outcomes of ImPACT scores and MRI findings between the two groups to see if there is a statistical difference in reduction of injury and to establish what the baseline level of MRI findings related to injury from high school football is as well as what the baseline level of injury is prior to the start of the season.

Screening Brain Magnetic Resonance Imaging (MRI) with Fluid-attenuated Inversion Recovery (FLAIR) and Susceptibility Weighted Imaging (SWI) sequences will be performed pre and post season on high school football players. One set of players will wear the Guardian Cap on their five star rated helmets and the other will wear five star rated helmets only. The investigators will compare outcomes of ImPACT concussion scores and MRI findings on FLAIR and SWI sequences between the two groups to see if there is a statistical difference in reduction of MRI findings on FLAIR and SWI sequences or adverse ImPACT concussion score outcomes and to establish what the baseline level of MRI findings on FLAIR and SWI sequences related to injury from high school football is as well as what the baseline level of MRI findings on FLAIR and SWI is prior to the start of the season.

Eligibility Criteria:
Inclusion Criteria:

* High school football players willing and able to have a pre and post season Brain MRI with FLAIR and SWI sequences and wear the Guardian Cap on their helmet

Exclusion Criteria:

* High school football players unwilling or unable to have an MRI
Modification of Coronary Calcium With Laser Based Intravascular Lithotripsy for Coronary Artery Disease (FRACTURE)

The FRACTURE Trial is a prospective, non-randomized, single-arm, multicenter, interventional study in US and international centers.

The FRACTURE Trial is a prospective, non-randomized, single-arm, multicenter, interventional study in US and international centers with the Bolt Intravascular Lithotripsy System that was designed to percutaneous transluminal angioplasty by utilizing delivery of IVL to disrupt calcium prior to full balloon dilatation at low pressures.

Eligibility Criteria:
Key Inclusion Criteria:

* Subject is ≥18 years of age;
* Subjects with native coronary artery disease (including stable or unstable angina and silent ischemia) suitable for Percutaneous Coronary Intervention (PCI);
* For patients with unstable ischemic heart disease, a local site-based biomarker (preferably troponin or hs-troponin) must be less than or equal to the upper limit of lab normal (ULN) within 12 hours prior to the study procedure;
* For patients with stable ischemic heart disease, CK-MB will be drawn at the time of the study procedure from the side port of the sheath; results need not be analyzed prior to enrollment, but must be less than or equal to the upper limit of lab normal (ULN);
* Single de novo target lesion stenosis of protected LMCA, or LAD, RCA, or LCX (or of their branches) with:

  * Stenosis of ≥70% and \<l00%; or
  * Stenosis ≥50% and \<70% (visually assessed) with evidence of ischemia via positive stress test, or fractional flow reserve value ≤0.80, or iFR \<0.90, or IVUS or OCT minimum lumen area ≤4.0 mm2;
* Evidence of calcification at the target lesion site by

  * angiography, with fluoroscopic radiopacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least one location and total length of calcium of at least 15 mm and extending partially into the target lesion, or
  * Intravascular Ultrasound (IVUS) or Optical Coherence Tomography (OCT), with presence of ≥270 degrees of calcium on at least 1 cross section;
* Ability to pass a 0.014" guidewire across the lesion.

Key Exclusion Criteria:

* Subject experienced an acute MI (STEMI or non-STEMI) within 30 days prior to index procedure;
* New York Heart Association (NYHA) class III or IV heart failure at time of index procedure;
* Prospective need for hemodynamic support, i.e., IABP or Impella;
* Chronic kidney disease with serum creatinine \>2.5 mg/dL, eGFR \<30 mL/min/1.73m2, or on chronic dialysis;
* Unprotected left main diameter stenosis \>50%;
* Target vessel is excessively tortuous defined as the presence of two or more bends \>90º or three or more bends \>75º;
* Target lesion is an ostial location (LAD, LCX, or RCA, within 5 mm of ostium) or an unprotected left main lesion;
* Chronic Total Occlusion;
* Target lesion is located in a native vessel that can only be reached by going through a saphenous vein or arterial bypass graft;
Synthetic Human Secretin in Children With Autism and Gastrointestinal Dysfunction

The purpose of the study is to determine the effect of multiple doses of secretin on autism.


Eligibility Criteria:
* Autism
* Gastrointestinal dysfunction
Relapse-Prevention Study With Levomilnacipran ER (F2695 SR) in Patients With Major Depressive Disorder

The purpose of this study is to evaluate the safety and efficacy of Levomilnacipran ER relative to placebo in the prevention of depression relapse in patients with major depressive disorder (MDD).

Patients who demonstrate improvement in depressive symptoms at the end of the initial 12-week open-label treatment period with Levomilnacipran ER are randomized to continue Levomilnacipran ER or switch to placebo under double-blind conditions for up to 24 weeks of additional treatment.

Eligibility Criteria:
Inclusion Criteria:

* Men and women, 18-65 years old
* Currently meet the DSM-IV-TR criteria for Major Depressive Disorder
* The patient's current depressive episode must be at least 4 weeks in duration

Exclusion Criteria:

* Women who are pregnant, women who will be breastfeeding during the study, and women with childbearing potential who are not practicing a reliable method of birth control
* Patients with a history of meeting DSM-IV-TR criteria for:

  * any manic or hypomanic episode
  * schizophrenia or any other psychotic disorder
  * obsessive-compulsive disorder
* Patients who are considered a suicide risk
"Effectiveness of Non-invasive Neuromodulation Treatment for Improving Sexual Satisfaction in Healthy Subjects.

The main objectives of the programming with the XSignal device will be to influence the sexual satisfaction of the participants.

As secondary objectives, the effectiveness of the XSignal device during a defined treatment period will be analyzed in terms of quality of life, pain, stress, anxiety, sexual function, sleep quality, cortisol, heart rate, blood pressure, respiratory rate, and body temperature of the same subjects, compared with a placebo group, observing the long-term influence of the results.

Considering the objectives set: In the first phase, the directing electrode will be located at C6-C7 to generate a systemic and general effect on the organism, with program 1, program 2, program 7, and program 8. In the second phase, the directing electrode will be placed at the abdominal level in the area of the mesenteric plexus to influence the sympathetic innervation of the viscera. In the third phase, the directing electrode is located at S2-S3 to concentrate the action of the therapy on the sacral parasympathetic plexus,. In this way, both the sympathetic and parasympathetic innervation of the main sexual organs are covered through the sympathetic paravertebral ganglia and the sacral plexus.

Eligibility Criteria:
Inclusion Criteria:

* Subjects from 18 to 65 years
* Sexually active
* Signed consent form

Exclusion Criteria:

* Diagnosed diseases.
* Severe previous psychiatric conditions.
* Medical contraindications that prevent the use of non-invasive neuromodulation therapy.
* Having exercised in the hours prior to the NESA treatment.
* Having consumed coffee or tobacco in the hours prior to the treatment.
* Minors.
* Individuals who have previously received any type of neuromodulation treatment.
* Cancer.
Safety of Omitting Axillary Surgery in Breast Cancer Patients With Isolated Chest Wall Recurrence

The axillary management of breast cancer patients with operable isolated chest wall recurrence after mastectomy is unclear. We aim to determine if axillary restaging surgery can be safely omitted with no increased recurrences in this group of patients.


Eligibility Criteria:
Inclusion Criteria: Mastectomy patients who developed pathologically confirmed invasive isolated chest wall recurrence.

-

Exclusion Criteria: -Patients with bilateral cancers

* Patients with evidence of concomitant distant or/and regional recurrences
* Patients who did not have surgery for their isolated chest wall recurrences.
Efficacy and Safety of FF-31501 in Meniscus Tear Patients

A single-arm, multi-center study to verify that knee joint function at 52 weeks after injection of FF-31501 is better than at screening in patients with meniscus tear who are eligible for meniscectomy .


Eligibility Criteria:
Inclusion Criteria:

1. Patients with suspected meniscal flap tear
2. Patients with knee pain
3. Patients with one or more of the following symptoms

   * Feeling stuck in the knee・Instability of the knee
   * Knee range of motion impairment
   * Knee joint edema
4. Other

Exclusion Criteria:

1. Patients with poor knee alignment
2. Patients who underwent meniscus surgery or platelet rich plasma therapy
3. Patients with or history of knee ligament injury
4. Diabetic patients with poor glycemic control
5. Patients with the following complications and poor general condition

   * Severe cardiovascular disease
   * Severe liver disease
   * Severe renal dysfunction
   * Severe anemia・uncontrolled mental illness
   * Other diseases for which sudden change or worsening of symptoms can be expected during study participation
6. Patients who are pregnant or possibly pregnant and/or breast-feeding, or patients planning to become pregnant during the study period
7. Other
Pharmacokinetic Study Of Valaciclovir Hydrochloride Tablets

Valaciclovir (VACV), the L-valyl ester prodrug of aciclovir (ACV), is extensively converted to ACV and L-valine after oral administration. In subjects with normal renal function, ACV is predominantly eliminated unchanged in the urine, with a small proportion metabolized to 9-carboxymethoxymethylguanine (CMMG). The metabolism of ACV to CMMG is thought to involve aldehyde dehydrogenase (ALDH). On the basis of a high proportion of the Japanese population having low-activity ALDH, it can be hypothesized that the conversion of ACV to CMMG is decreased, thereby leading, in patients with renal impairment, to higher plasma concentrations of ACV. This pilot study was conducted to investigate potential relationships between genetic polymorphisms of ALDH2, an isozyme of ALDH, and the plasma pharmacokinetics (PK) of VACV, ACV and CMMG in subjects with end-stage renal disease on hemodialysis.


Eligibility Criteria:
Inclusion criteria:

* Japanese subjects with chronic renal failure undergoing hemodialysis regularly three times a week for at least 12 weeks prior to the start of the study.

Exclusion criteria:

* Subjects with current alcohol dependence.
* Subjects with gastrointestinal dysfunction that may affect drug absorption.
* Subjects who have received an organ transplant (However, subjects with a corneal transplant or any other organ transplant that may not affect the objectives of the study will be eligible for inclusion in this study).
A Study of RO4607381 in Patients With Coronary Heart Disease (CHD) or a CHD Risk Equivalent.

This 2 arm study will investigate the efficacy and safety of RO4607381 in patients with coronary heart disease, or CHD risk equivalent. After a pre-randomization phase of 5-12 weeks, patients will be randomized to receive either RO4607381 (900mg po) or placebo po daily for 24 weeks, with concomitant atorvastatin 10-80mg daily, and changes in cholesterol level and lipoprotein metabolism will be measured. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, 18-75 years of age;
* CHD or CHD risk equivalent;
* body weight \<125kg at visit 1.

Exclusion Criteria:

* recent (within 3 weeks of screening) clinically significant coronary events;
* history of statin-associated myopathy, or intolerance to statin;
* history of malignancy (except for curatively treated basal cell or squamous cell cancer of the skin) during the 3 years prior to screening;
* exposure to RO4607381 in past 12 months.
Sickle Cell Improvement: Enhancing Care in the Emergency Department

Sickle cell disease (SCD) is an inherited blood disorder affecting approximately 36,000 children in the United States, approximately 90% of whom are Black. The disease is characterized by recurrent, severe pain crises which result in high rates of emergency department visits and hospitalizations, and decreased quality of life. The National Heart, Lung and Blood Institute, as well as the American Society of Hematology, have endorsed pain management guidelines regarding the timeliness of care for children presenting with these acute pain crises. These evidence-based guidelines are infrequently followed, resulting in increased pain and hospitalizations. In additional to other barriers to following the guideline, structural racism has been proposed as a significant contributor and the New England Journal of Medicine recently called for the institution of SCD-specific pain management protocols to combat structural racism and reduce time to opioid administration. The investigators' long-term goal is to improve the care and health outcomes of children with acute painful vaso-occlusive crisis treated in the emergency department. The overall aim of the investigators is to test a care pathway using multifaceted implementation strategies to increase guideline adherent care for children in the emergency department with acute painful vaso-occlusive crisis.


Eligibility Criteria:
Inclusion Criteria:

* ED visit for uncomplicated pain crisis
* Sickle cell disease
* Receipt of at least one opioid

Exclusion Criteria:

* Acute chest syndrome
* Fever \> 38.5 in the ED
* priapism
* sickle cell trait
Role of Lung Ultrasound Imaging for Intraoperative Monitoring of Atelectasis During Laparoscopic Surgery

General anesthesia results in the development of atelectasis in the dependent areas of the lungs exposing patients to an increased risk of hypoxemia. During laparoscopic procedures, pneumoperitoneum increases already present atelectasis.

Several methods have been suggested to reduce the impact of atelectasis during surgery. However, few intraoperative modalities for the diagnosis and monitoring of atelectasis are available. Lung ultrasound imaging is a promising non-invasive, non-radiant, portable and easy to use tool that as yet to be studied in the intraoperative setting.

This observational study will aim to clarify the role of lung ultrasound imaging during laparoscopic surgery for the diagnostic and monitoring of atelectasis.

This study is designed to:

* Demonstrate a link between the lung ultrasound aeration score, the partial pressure of oxygen in arterial blood (PaO2) / fraction of inspired oxygen (FiO2) ratio and the oxygenation index.
* In the event of intraoperative desaturation, study the impact of positive end-expiratory pressure (PEEP) and/or increase of FiO2 on the aeration score.
* Study the impact of pain on diaphragmatic function and the aeration score.

Our hypothesis is that lung ultrasound imaging allows detection of lung aeration changes associated with induction of general anesthesia, pneumoperitoneum, emergence from anesthesia and changes occurring during the stay in the recovery room.

On arrival in the operating theatre, each patient will undergo a baseline lung ultrasound examination.

The anesthetic technique and monitoring will be standardized. The radial artery will be cannulated after induction of anesthesia for blood gas monitoring.

Lung ultrasound examinations will be performed 5 minutes following induction of general anesthesia and 5 minutes after insufflation of the abdomen with carbon dioxide. In the event of a desaturation needing an intervention (increase of FiO2 or PEEP), ultrasound imaging will be repeated before and after the intervention. Presence of a pneumothorax or endobronchial intubation will be assessed during each examination. Fifteen minutes after arrival and immediately before discharge from the recovery room, lung ultrasound examinations will also be performed.

FiO2 and vital signs will be recorded at each ultrasound examination. Arterial blood samples will be collected simultaneously. Pain rating using the visual analog scale and diaphragmatic function will be assessed during the preoperative ultrasound examination and before discharge from the recovery room.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years and older
* Scheduled for laparoscopic surgery
* Physical status 1-3

Exclusion Criteria:

* Previous thoracic procedure (thoracic drain, thoracotomy, thoracoscopy)
* Contraindication to the placement of an arterial line
* Very severe chronic obstructive pulmonary disease
Assessment of Hearts Deemed Unsuitable for Transplant With the Aim of Expanding the Donor Heart Pool.

The main question to be asked in this study is what is the potential for human hearts that have been deemed unacceptable for transplant, to be explanted and re-animated in a controlled, external environment to be assessed? Furthermore would the reanimated hearts be able to undergo improvement in their function in this external environment.

Ultimately this may lead to an increase the number of hearts available for transplantation.

Year on year with improvement in road safety and improvement in neurosurgery the number of ideal young brain dead donors have been declining whilst the number of more marginal donors have been increasing. The consequence of this is the number of heart transplants being performed have steadily declined.

At present there are 600 hearts from brain dead donors offered for transplant every year in the United Kingdom (UK). Of these 200 have anatomical reasons why they cannot be used for transplant such as ischaemic heart disease. 100 are transplanted and the remaining 300 hearts are judged to have inferior function which probably occurs as a direct result of brain death (Dark).

Ex vivo 'rig' testing has been developed for lungs that were judged unsuitable for transplantation. As a result several donor lungs have been 'improved' by warm perfusion on the rig to the extent that they became suitable for transplantation and so national lung transplant rates are increasing (Dark). The aim would be to develop a similar approach for the heart.

Eligibility Criteria:
Inclusion Criteria:

* Participant is brain dead and their relative is willing to give informed consent
* Male or Female, aged between 18 and 75 years
* Heart is not eligible for transplantation

Exclusion Criteria:

* Participant's relative refuses consent
* Brain dead donor whose heart is eligible for transplantation
A Study of the Safety and Anesthetic Effect of AG-920 Topical Ophthalmic Solution

This is a Phase 3, randomized, placebo-controlled, double masked, parallel design study in healthy subjects performed in the US. It is designed to evaluate the safety and anesthetic efficacy of AG-920 Sterile Topical Ophthalmic Solution.

This is a Phase 3, randomized, placebo-controlled, double masked, parallel design study in healthy subjects performed in the US. It is designed to evaluate the safety and anesthetic efficacy of AG-920 Sterile Topical Ophthalmic Solution. In this study, subjects who provide informed consent and fulfill all the inclusion criteria and none of the exclusion criteria will be randomized in a 1:1 ratio to receive a single dose of AG-920 or identical looking placebo into the study eye. Subjects will undergo a conjunctival pinch procedure and the pain associated with the pinch rated.

Eligibility Criteria:
Inclusion Criteria:

1. Provide written informed consent prior to any study-related procedures being performed.
2. Is male or a non-pregnant, non-lactating female aged 18 years or older.
3. Willing and able to follow instructions and be present for the required study visits.
4. Have an Early Treatment Diabetic Retinopathy Study (ETDRS) Best Correct Visual Acuity (BCVA) of 20/200 or better in each eye.
5. Have an Intraocular Pressure (IOP) between 7 and 30 mmHg.
6. Certified as healthy by clinical assessment.
7. Verbal communication skills adequate to participate.
8. Able to tolerate bilateral instillation of Over-The-Counter artificial tear product based on investigator judgement.

Exclusion Criteria:

1. Have participated in an investigational study within the past 30 days.
2. Have a contraindication to local anesthetics.
3. Have known decreased corneal or conjunctival sensitivity.
4. Have had ocular surgery in either eye within the past 90 days.
5. Have had an intravitreal injection in either eye within 14 days.
6. Have ocular disease requiring punctual plugs or ocular inflammation.
7. Are currently using a systemic opioid or opiate analgesic or topical NSAID.
8. Cannot withhold their over the counter (OTC) artificial tear lubricant products for one hour preceding or following study medication.
9. Any condition, including alcohol or drug dependency, that would limit the subject's ability to comply with the procedures of the protocol.
Cardiovascular Effects of CART Cell Therapy

This is an observational study aiming to prospectively define the rate of occurrence, natural history and progression of cardiac dysfunction in adults, and to identify the patients at high risk of developing cardiovascular events. The study enrolls patients prior to infusion with CART cell therapy and follows them with serial echocardiography, cardiac biomarkers, clinical data, and quality of life questionnaire.

Patients have echo, blood draw, and QoL survey prior to CART infusion, then 2 days, 1 week, 1 month and 6 months following CART infusion. If patients experiences CRS, study team acquires echo within 72 hours of onset. As part of an optional substudy, patients wear an event monitor for 10 days, starting day of CART infusion.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Diagnosed with CD19+ malignancy undergoing treatment with CART cells

Exclusion Criteria:

* Unable to provide informed consent