cyrilzakka/clinical-trials huggingface dataset:
Three New Ideas to Protect Special Forces From the Stress of High Altitude

Acute Mountain Sickness (AMS) is a well-documented syndrome that affects 42% of non-acclimatized individuals traveling to altitudes above 10,000 feet. Decreased barometric pressure, which leads to low blood oxygen levels, is the primary casual factor of AMS. Symptoms of AMS are characterized by headache, nausea, vomiting, dizziness, fatigue and difficultly sleeping. Moreover, when people travel to high altitude, cognitive performance and endurance exercise capacity are impaired. Therefore, the goal of this research is to identify effective pharmacological agents that will help reduce the symptoms of AMS and improve physical and cognitive performance at high altitude.

The investigators will study the efficacy of the dietary supplement, quercetin, the drugs nifedipine (extended release) and methazolamide taken together, the drug metformin, and the drug nitrite in reducing symptoms of AMS and improving cognitive and exercise performance at high altitudes.


Eligibility Criteria:
Inclusion Criteria:

* healthy,
* young (18-30 years old) men who can meet APFT requirements for special operation forces (SOF) training as outlined by the US Army (42 push ups, 53 sit-ups, 6 pull-ups, 2 mile run in \< 15 min 54 s)

Exclusion Criteria:

* women;
* smokers;
* participants with diseases or disorders known to be affected by hypoxia or the drugs used in this study, such as hypotension, anemia, sickle cell trait or disease, and diabetes;
* participants with a history of significant head injury, migraines or seizures;
* participants taking any medication (over-the-counter or prescription) or herbal supplements;
* participants with known flavonoid allergies;
* participants with known allergies to metformin;
* participants with known hypersensitivity reaction to nifedipine;
* participants with known allergies to sulfonamide-based drugs;
* participants with inability to be headache-free when consuming the amount of caffeine in two six ounce cups of coffee or less per day;
* exposure to high altitude above 1000m in the previous three months; or
* participants who have been on an airline flight over six hours (the lowered cabin pressure for an extended period of time approximates exposure to high altitude);
* participants who are unable to achieve the minimum physical criteria required for SOF training
Head and Neck Trauma Registry, Protocol ID: 032.MBSI.2021.D

This is a retrospective registry dataset of all adults who presented with cervical and/or skull base fractures or a subdural hematoma at Methodist Dallas Medical Center (MDMC) and had consults to the neurological surgery department beginning in January of 2016, and continuing until a statistically significant number of cases are obtained.

This is a retrospective registry dataset of all adults who presented with cervical and/or skull base fractures or a subdural hematoma at Methodist Dallas Medical Center (MDMC) and had consults to the neurological surgery department beginning in January of 2016, and continuing until a statistically significant number of cases are obtained. Subjects will undergo no additional tests or procedures as part of this registry study. All patient data will be obtained from the patient's electronic health records of the hospital or clinic in a retrospective manner. The process for gathering the data will not influence treatment decisions. There will be no direct patient contact associated with inclusion in this registry study.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age or older
* Presenting to MDMC with cervical and/or skull base fractures or those with subdural hematomas

Exclusion Criteria:

* Do not meet the Study Inclusion Criteria laid out in section 4.1.
* Vulnerable populations
Intranasal Dexmedetomidine Sedation for Pediatric CT Imaging

This study has the objective to determine if intranasal dexmedetomidine, a sedative, is suitable for pediatric sedation in children undergoing tomographic scans.

Invasive procedures for diagnosis in children are a routine part of an emergency care department. Most of these procedures are painful and uncomfortable for both the child and for their families, and impossible to be performed without patient immobilization. Thus, procedural sedation is critical to this end. Procedural sedation can be defined as the use of sedatives, analgesics, or dissociative drugs for anxiolysis, analgesia, sedation and motor control during painful procedures.

The increasing demand of pediatric emergency services and, consequently, the performance of procedures that require sedation, made it impossible for universal coverage of anesthesiologists in such procedures. As a result, a wide variety of drugs, sedation techniques and different degrees of effectiveness and adverse effects of sedation, such as irritability and sedation failure are described.

Particularly in children who need CT scan, there is usually no need for venous access for sedation. However, our most used drug, chloral hydrate, was abandoned in most centers outside the country. When administered orally, the drug produces malaise and vomiting, and gastric mucosal irritation, in addition, the rectal absorption is unpredictable. Additionally, in recent years increasing importance has been given to the fact that the drug be related, in vitro, the increased carcinogenicity in mice by cellular structural change, which is leading to the ban of same drug in the United States and in some european countries.

Dexmedetomidine is a highly selective alpha-2 agonist receptors, which has the advantage of mimicking natural sleep, according to electroencephalographic studies, with low incidence of adverse events. Its application as a sedative in pediatric procedures, as well as pre-anesthetic medication, has been increasingly described according to recent studies. The intranasal route has been used with the advantage of avoiding a venous line or intramuscular injection, with good results; however, it hasn't been described yet in children undergoing CT scans.

Thus, this work is justified to describe, in a pioneering way, the use of intranasal dexmedetomidine for sedation for CT, documenting its efficacy and safety in a specific cohort of patients sedated for this purpose.

Eligibility Criteria:
Inclusion Criteria:

* Children between 1 month to 15 years old undergoing CT scans in the pediatric emergency department

Exclusion Criteria:

* Glasgow coma scale \< 13
* Epistaxis or suspected base skull fracture
* Use of contrast or need for an IV line before sedation
* Uncontrolled gastroesophageal reflux or vomiting
* Current (or within past 3 months) history of apnea of prematurity requiring an apnea monitor
* Acute, unstable respiratory disease
* Unstable cardiac status
* Craniofacial anomaly
* Medication use: digoxin
* Moya Moya Disease
* New onset stroke
* American Society of Anesthesiologists physical status ≥3
Continued Ventilation During Cardiopulmonary Bypass

Cardiopulmonary bypass (CPB) is well known to induce a strong anti-inflammatory response. The investigators examined whether continued mechanical ventilation during CPB alters systemic immune activation.

Cardiopulmonary bypass is well known to induce a strong anti-inflammatory response. Studies had been shown that the contact of blood components with artificial surfaces, the surgical trauma, endotoxemia and a reperfusion injury are in part responsible for the seen immunological affect after surgery. The purpose of this study is to test the effect of continued mechanical ventilation during surgery on a blood marker called soluble ST2 in patients sera. Soluble ST2 acts as a decoy receptor of IL-33 and has anti-inflammatory effects. Elevated soluble ST2 concentrations are reported in patients with acute myocardial infarction, sepsis, congestive heart failure and elevates soluble ST2 levels are associated with adverse outcome.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* age \> 40 and \< 80

Exclusion Criteria:

* treatment with steroids or immunomodulatory interventions during the past four weeks
* signs of an acute infection
Comparison of Precision in Brackets Position in Two Indirect Bonding Materials

Objective: To compare the cementation precision of self-ligating brackets between two indirect bonding materials: polyvinylsiloxane and thermal glue.

Methods: Split-mouth randomized clinical trial study, with 15 participants. The study will be divided into two groups, Group 1: Polyvinylsiloxane and Group 2: Thermal glue.

Patients from the self-ligation clinic who meet the inclusion criteria will be invited to participate and sign the informed consent. For the cementation of the brackets in each patient, the upper arch (right and left) will be divided from the second premolar on the right side to the second premolar on the left side, randomly assigned, to be cemented with a polyvinylsiloxane transfer tray and the other with thermal glue (materials selected for the study).

Eligibility Criteria:
Inclusion Criteria:

* Permanent dentition with the presence of teeth 15-25 with
* Crowding in the upper arch according to Little's irregularity index,
* Teeth with healthy enamel (without hypoplasias, fluorosis, amelogenesis imperfecta),
* Fully erupted teeth

Exclusion Criteria:

* Absence of teeth selected for the study or that required premolar extractions before starting alignment and leveling
* Patients with rehabilitation such as crowns, veneers, fractured dentition, atypical morphology
* Teeth whose bracket loosens at the time of the procedure due to failure of the union
* Poor oral hygiene
* Patients with any significant displacement of the tooth that could prevent seating of the transfer tray
* Study models with bubbles.
GET Living: Graded Exposure Treatment for Children and Adolescents With Chronic Pain

The broad aim of this study is to implement and evaluate the efficacy of Graded Exposure Treatment (GET Living) to target elevated pain-related fears in children with chronic pain at the Stanford Pediatric Pain Management Clinic (PPMC). The investigators will evaluate the effectiveness and acceptability of this intervention for children with high levels of pain-related fear and functional disability. If proven efficacious, it will allow for the dissemination of this innovative treatment model to others working with children and adolescents with chronic pain.

The treatment intervention to be tested in this clinical trial is Graded in-vivo Exposure Treatment (GET Living) compared to Multidisciplinary Pain Management (MPM) in adolescents with chronic musculoskeletal pain. Participants will be randomized into GET Living or MPM, and will be instructed to not seek new treatments for pain for the duration of the study. Both treatments consist of 12 1-hour patient sessions delivered twice a week across 6- weeks and 3 parent-only sessions.

Eligibility Criteria:
Inclusion Criteria:

* 8 - 18 years old; Male or Female
* Musculoskeletal pain (e.g. localized \[back, limb\], diffuse) not due to acute trauma (e.g. active sprain or fracture).
* Moderate to high pain-related fear ( ≥ 35 on the FOPQ-C)
* Moderate to high functional disability ( ≥ 13 on the FDI)
* English Language Proficiency

Exclusion Criteria:

* Significant cognitive impairment (e.g., brain injury)
* Significant medical or psychiatric problem that would interfere (e.g., seizures, psychosis, suicidality)
Emotional Awareness and Expression Therapy (EAET) or Cognitive Behavior Therapy (CBT) for Older Veterans With Chronic Musculoskeletal Pain

A randomized clinical trial for Veterans age 50 years and older with chronic musculoskeletal pain in which Emotional Awareness and Expression Therapy (EAET) is compared against Cognitive Behavior Therapy (CBT) to evaluate acceptability, feasibility, and efficacy of the two treatments on pain and other outcomes, as well as potential mediators of treatment response.

Outpatient Veterans age 50 years and older at the West Los Angeles VA Medical Center who have chronic musculoskeletal pain complete baseline questionnaires and are randomized into one of two forms of psychotherapy: Emotional Awareness and Expression Therapy (EAET), which helps patients make connections between avoided or conflicted emotions and pain, or Cognitive Behavior Therapy (CBT), which teaches pain coping skills. Each treatment is delivered by an experienced therapist and includes one 90-minute individual session and eight 90-minute group sessions (in small groups of 8 Veterans). Patients in both conditions complete post-treatment and 3-month follow-up questionnaires. Outcomes of each type of psychotherapy are compared and mediators of treatment response are evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Veteran;
* Age 50 years and older;
* 3 months of musculoskeletal pain including low back pain and other regional pain syndromes (e.g. neck, leg, pelvic pain and temporomandibular joint disorders), whiplash, widespread pain (e.g. fibromyalgia), or tension headaches.

Exclusion Criteria:

* Leg pain greater than back pain (to exclude radiculopathy in isolation);
* Electromyography (EMG)-confirmed "tunnel" syndromes (e.g. carpal or tarsal tunnel syndrome) without any other pain complaints;
* Autoimmune disease that typically generates pain (e.g. systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, ankylosing spondylitis);
* Confirmed hip or knee osteoarthritis without any other pain complaints;
* Cancer pain, sickle cell disease, neuralgias (e.g. trigeminal neuralgia), burn pain, infection associated with pain (e.g. vertebral infection), cauda equina syndrome, gout as the only pain complaint, migraine or cluster headaches only;
* Uncontrolled severe psychiatric disorder including current psychotic disorder (e.g. schizophrenia or bipolar I disorder not controlled with medications), dissociative identity disorder, or active suicide/violence risk in the past 6 months;
* Moderate to severe cognitive impairment or dementia (Mini-Mental State Exam score ≤ 25);
* Active severe alcohol or substance use disorder that inhibits the participant's ability to attend sessions or participate in homework;
* Currently with pain-related litigation or applying for compensation or compensation increase (e.g. applying for VA service connection or applying for VA service connection increase for pain);
* Unable to fluently read/converse in English;
* Planning to move from the area in the next 6 months.
Serial, Non-invasive Analysis of Exhaled Breath Condensate in Ventilated Trauma Patients

To determine if the analysis of exhaled breath condensate correlates with the development \& resolution of pneumonia.

This proposal investigates the utility of exhaled breath condensate fluid (EBCF) collected from heat moisture exchange (HME) filters connected to patient's endotracheal tubes for early, non-invasive detection of ventilator-associated pneumonia (VAP) in critically ill or injured ICU patients. The development of pneumonia during mechanical ventilation is the most common healthcare-associated infection in severely injured patients, accounting for substantial morbidity, excess ICU and hospital stay, additional cost and increased mortality.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Admitted to the Vanderbilt Trauma (TICU) and Surgical Intensive Care Units (SICU)
* Mechanically ventilated for ≥2 successive days (without planned extubation within 24 hours of enrollment)

Exclusion Criteria:

* Less than 18 years of age
* Expected survival less than 24 hours
* Anticipated extubation within 24 hours of enrollment
* Conditions limiting the subject's ability to tolerate collection of lavage specimens, including: FIO2 \> 80%; PEEP \> 16 cmH2O; Intracranial pressure \>20 cmH2O; Tracheal or mucosal bleeding; Platelet count \< 20,000 cells/uL; INR \> 2.0
* Known prisoners
* Pneumonia diagnosis at the time of ICU admission
A Study of A-101 Topical Solution Administered Twice a Week in Subjects With Common Warts

The primary objective of this study is to evaluate the effectiveness of A-101 compared to Vehicle when applied to 1 Target common wart on the trunk or extremities twice a week.

The primary objective of this study is to evaluate the effectiveness of A-101 compared to Vehicle when applied to 1 Target common wart on the trunk or extremities twice a week.

The secondary objectives of this study are to evaluate the clinical effect of A-101 when applied to all treated Warts (Target Warts plus Non-Target Warts) twice a week, duration of response in all treated Warts (Target Warts plus Non-Target Warts), and safety of A-101.

Eligibility Criteria:
Inclusion Criteria:

* Subject is able to comprehend and is willing to sign an informed consent/assent for participation in this study.
* Male or female ≥ 8 years old.
* Subject chemistry and complete blood count results are within normal limits. If any of the laboratory values are outside normal range, the treating investigator must assess the value/s as NOT clinically significant and document this in the subject's medical chart in order for the subject to be eligible for randomization.
* Woman of childbearing potential (WOCBP) must have a negative urine pregnancy test within 14 days of the first application of study drug and agree to use an active method of birth control for the duration of the study.
* Subject is non-pregnant and non-lactating.
* Subject is in good general health and free of any known disease state or physical condition which, in the investigator's opinion, might impair the evaluation of any Target and Non-Target Warts or which exposes the subject to an unacceptable risk by study participation.
* Subject is willing and able to follow all study instructions and to attend all study visits.

Exclusion Criteria:

* Subject has clinically atypical warts on the trunk or extremities.
* Subject is immunocompromised (e.g., due to chemotherapy, systemic steroids, genetic immunodeficiency, transplant status, etc.)
* Subject has a history of Human Immunodeficiency Virus (HIV) infection
* Subject has had any Human Papilloma Virus (HPV) vaccine within 1 year prior to Visit 1
* Subject has a history of sensitivity to any of the ingredients in the study medications.
* Subject has any current skin disease (e.g., psoriasis, atopic dermatitis, eczema, sun damage), or condition (e.g., sunburn, excessive hair, open wounds) that, in the opinion of the investigator, might put the subject at undue risk by study participation or interfere with the study conduct or evaluations.
* Participation in another therapeutic investigational drug trial in which administration of an investigational study medication occurred with 30 days prior to Visit 1.
Study to Assess Adverse Events and Change in Disease Activity of Oral Cariprazine Capsules in Adult Participants With Schizophrenia

Schizophrenia is a common and severe psychiatric illness characterized by extreme disturbances of cognition and thought, affecting language, perception and sense of self. This study will assess how safe and effective cariprazine is in treating adult participants with schizophrenia in Japan and Taiwan. Adverse events and change in disease activity will be assessed.

Cariprazine (VRAYLAR) is an approved drug for the treatment of schizophrenia in the United States. In the first 6-week period, participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo. In the next 18-week period, participants will have the option to receive 1 of 3 doses of cariprazine. Approximately 250 adult participants, 18-65 years of age with schizophrenia will be enrolled in approximately 55 sites across Taiwan and Japan.

Participants will receive oral capsules of cariprazine or placebo for 6 weeks. Upon completion of 6-week treatment period, participants will be eligible to receive oral capsules of cariprazine for additional 18 weeks. The safety follow up period will follow after for an additional 8 weeks.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with schizophrenia at least 1 year before informed consent.
* Experienced a persistent psychotic episode within 2 months prior to informed consent requiring treatment modifications as judged by the investigator or sub-investigator.

Exclusion Criteria:

- History of clinically significant medical conditions or any other reason that the investigator (or subinvestigator) determines would interfere with the participant's participation in this study or would make the participant an unsuitable candidate to receive study drug.
Bulbar Function in Neuromuscular Patients

The main objective is prospectively study the upper airways function in an adult population of neuromuscular patients. The main measurement will be the evolution of tongue strength recorded each year during annual clinical evaluation on a 5 years period.

The main objective is to study the function of the superior airways (tongue and pharynx) in an non invasive way in neuromuscular patients followed in the home ventilation unit of the Raymond POINCARE hospital (myopathy, neuropathy, disease of the neuromuscular junction or anterior horn) or of Necker Hospital and to detect prematurely the bulbar dysfunction.

The secondary objectives of this prospective monocentric observational physiopathological study are:

1. to study the correlation between the possible swallowing dysfunction and the anomalies of the respiratory parameters
2. to establish correlations between infraclinical or clinical and presence of morphological tongue anomalies detected by magnetic resonance imaging like in acid maltase deficiency.

The maximal tongue strength protrusion will be measured according to a method already used in the laboratory to explore sleep apnea syndromes.

Swallowing will be estimated by a non invasive method already used to highlight swallowing disorders in neurological and muscular pathologies This method will be associated with a method of recording of thoracic and abdominal movements.

Data wil be compared to a control database obtained for a previous study

Eligibility Criteria:
Inclusion Criteria:

* neuromuscular disorder
* age greater than or equal to 6
* Hospitalization in Home Ventilation Unit - Written informed consent

Exclusion Criteria:

* patient's refusal to participate
* major swallowing disfunction
* Acute respiratory failure
* no affiliation to social security