cyrilzakka/clinical-trials huggingface dataset:
Hand Held Nitrous Oxide Delivery Device

To study the safety and efficacy of Hand Held Nitrous. A device that delivers 120 seconds of up to 72% nitrous oxide and ambient air.

This study assesses the Hand Held Nitrous Oxide Deliver Device which is intended to be used in nitrous oxide sedation systems by delivering a limited 16 grams of nitrous oxide over a total of 120 seconds of inhalation time.

The device creates short term minimal sedation by delivering a maximum 72% USP grade nitrous oxide / 28 % ambient air combination which quickly drops to under 33% nitrous oxide / 67% ambient air in 60 seconds and stays steady until all the gas is expelled.

Eligibility Criteria:
Inclusion Criteria:

* Any patient undergoing a painful office procedure or exam

Exclusion Criteria:

* Women that are Pregnant
* Children under three years of age
Evaluation of Postural Control in Children With Idiopathic Toe Walking

The aim of this study is to evaluate postural control in children with idiopathic toe walking using computerized dynamic posturography (Biodex Balance System), which is reported to be a reliable and valid instrument for detecting changes in balance and postural control in the literature.

Idiopathic toe walking (ITW) is a term used to describe the condition in which children walk with a toe-toe gait pattern in the absence of any known cause. When the literature is examined, it is reported that a possible neuromechanism of idiopathic toe walking is related to postural disorder and a deterioration of sensory information coming from the proprioceptive, vestibular, visual and / or tactile systems. The most important function of the posture is to maintain the balance during the initiation and continuation of the movement. Postural control regulates maintaining the balance and keeping the center of gravity within the body's stability limits. It includes resistance to gravity forces and mechanical support during movement. Postural control is an integral part of achieving targeted action. Although there are few studies showing the possible relationship, no studies have been found to evaluate postural control by computerized posturography in these children. In this study, we aimed to evaluate postural control in children with idiopathic toe walking using computerized dynamic posturography (Biodex Balance System).

Eligibility Criteria:
Inclusion Criteria:

* Having the diagnosis of idiopathic toe walking
* No contact with the heel in the initial contact phase of the gait
* Presence of bilateral toe walking gait
* Normal neurological and orthopedic examination results
* Achievement of independent walking before 18 months
* Absence of pervasive developmental disorder or autism

Exclusion Criteria:

* A history of BoNT-A or surgery in the last 6 months
* Presence of leg length discrepancy
Evaluation of Protease Inhibition for COVID-19 in Standard-Risk Patients (EPIC-SR).

The primary hypothesis to be tested is whether or not there is a difference in time to sustained alleviation of all targeted COVID-19 signs and symptoms through Day 28 between PF-07321332/ritonavir and placebo.

Throughout the study period, provision will be made to allow study visits to be conducted at a participant's home or at another non-clinic location, if available. The total study duration is up to 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed SARS-CoV-2 infection 5 days prior to randomization
* Initial onset of COVID-19 signs/symptoms within 5 days of randomization
* Fertile participants must agree to use a highly effective method of contraception

Exclusion Criteria:

* Has at least one underlying medical condition associated with an increased risk of developing severe illness from COVID-19
* History of or need for hospitalization for the medical treatment of COVID-19
* Prior diagnosis of SARS-CoV-2 infection (reinfection)
* Known medical history of liver disease
* Receiving dialysis or have known renal impairment
* Known Human Immunodeficiency Virus (HIV) infection with viral load \> 400 copies/ml or taking prohibited medications for HIV treatment
* Suspected or confirmed concurrent active systemic infection other than COVID-19
* Current or expected use of any medications or substances that are highly dependent on Cytochrome P450 3A4 (CYP3A4) for clearance or are strong inducers of CYP3A4
* Has received or is expected to receive monoclonal antibody treatment or convalescent COVID-19 plasma
* Has received any SARS-CoV-2 vaccine within 12 months of screening
* Participating in another interventional clinical study with an investigational compound or device, including those for COVID-19
* Known prior participation in this trial or other trial involving PF-07321332
* Oxygen saturation of \< 92% on room air
* Females who are pregnant or breastfeeding
Efficacy of Ivermectin in COVID-19

It is a randomized controlled trial to assess the efficacy of Ivermectin in COVID-19. Patient recruited will be assigned to two groups one group will be given ivermectin with standard chloroquine regimen and the other group will be receiving chloroquine only. Out come will be recorded by documenting PCR reports at 48, 96 and 144 hours.

INTERVENTION It will be a randomized controlled trial which will be done on COVID-19 patients proven by PCR fulfilling the criteria (asymptomatic/mild to moderate severity). They will be divided into two groups after randomization. Group A will be administered Ivermectin single dose of 12grams along with Chloroquine as per existing hospital guidelines and group B will be given Chloroquine alone. Dose of Ivermectin to be repeated at 1 week if PCR stays negative. PCR will be done on alternate days (48, 96 and 144hours) and the duration at which the PCR becomes negative will be compared. Dose of drug subject to change in accordance with patient response or possible side effect.

ELIGIBILITY CRITERIA INCLUSION CRITERIA

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study Male or female, aged 15 to 65 years In good general health with no or mild symptoms of Corona virus disease PCR positive for SARS-Cov-2. Ability to take oral medication and be willing to adhere to the drug intake regimen EXCLUSION CRITERIA

An individual who meets any of the following criteria will be excluded from participation in this study:

Severe symptoms likely attributed to Cytokine Release Storm. Malignant diseases, diabetes mellitus, chronic kidney disease and cirrhosis liver with CPT class B or C.

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Male or female, aged 15 to 65 years
* In good general health with no or mild to moderate symptoms of Corona virus disease
* PCR positive for SARS-Cov-2.
* Ability to take oral medication and be willing to adhere to the drug intake regimen

Exclusion Criteria:

* Severe symptoms likely attributed to Cytokine Release Storm.
* Malignant diseases, diabetes mellitus, chronic kidney disease and cirrhosis liver with CPT class B or C.
Immunological Interaction Between the Host and Candida Albicans Biofilm

Candida albicans is one of the most common nosocomial infection and the onset relies on the host immune status. The purpose of this study is to determine the immunological profile of patients infected with Candida albicans, that could ideally lead to a strategy to identify patients who could benefit from prophylaxis.


Eligibility Criteria:
Inclusion Criteria:

* Patients infected with Candida albicans
* Patients not infected with Candida albicans

Exclusion Criteria:

* Underage patients
* Non consenting patients
* Unconscious patients
Cytokine Removal by CRRT in Pediatric Sepsis

This pilot study will compare the effect of diffusive versus convective Continuous Renal Replacement Therapy (CRRT) in children with sepsis who require CRRT.

The hypothesis for the study is that convective forms of CRRT provide enhanced clearance of cytokines and improved clinical responses as compared to a diffusive CRRT modality.

The purpose of this study is to test the hypothesis that convective forms of Continuous Renal Replacement Therapy (CRRT) provides enhanced clearance of cytokines compared to a diffusive CRRT modality. Also, we plan to test the hypothesis that patients who receive convective CRRT modalities demonstrate improved clinical responses to patients who receive a diffusive CRRT modality.

Eligibility Criteria:
Inclusion Criteria:

* Patients with documented sepsis or suspected SIRS
* Patients initiating CRRT
* Age 1 to 21 years

Exclusion Criteria:

* Patients on ECMO
* Patients receiving concomitant plasma exchange
* Cardiopulmonary bypass procedure within 96 hours of CRRT
* Patients with new onset acute leukemia
* Patients with active autoimmune disease
* Ungrafted stem cell transplant recipients
Study to Determine if Contacting Patients With MTC More Frequently Results in Earlier Detection and Treatment of Signs and Symptoms of AEs and Thus a Decrease in the Percentage of Time Patients Experience AEs During First 12 Months on Vandetanib Treatment

The purpose of this study is to evaluate the effect of patient outreach program on the proportion of time patients with MTC experience moderate or severe AEs during first 12 months of treatment with vandetanib


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent prior to any study specific procedures
* Female or male aged 18 years and over
* Previously confirmed histological diagnosis of unresectable, locally advanced or metastatic hereditary or sporadic MTC. Documentation must be provided in patient's medical chart
* WHO or ECOG Performance status 0-2
* Negative pregnancy test (urine or serum) for female patients of childbearing potential

Exclusion Criteria:

* Unstable brain metastases or spinal cord compression that require treatment, unless treated at least 4 weeks before first dose and stable without steroid treatment for 10 days
* Major surgery within 4 weeks before randomization
* The last dose of prior chemotherapy received less than 3 weeks prior to randomization
* Radiation therapy not completed prior to the first dose of vandetanib
* Significant cardiac event, superior vena cava syndrome, NYHA classification of heart disease ≥2, within 12 weeks before randomization, or presence of cardiac disease that in the opinion of the Investigator increases risk of ventricular arrhythmia
* Creatinine clearance \<30 ml/min (calculated by Cockcroft-Gault formula),Patients with moderate renal impairment, defined as creatinine clearance ≥30 to \<50 ml/min, must start vandetanib at a reduced dose of 200 mg
Comparison of Tolerability Between Two Allergy Drops

Comfort is compared between two allergy drops


Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18 and over inclusive.
* Males or females
* Patient is in generally good \& stable overall health.
* Patient likely to comply with study guidelines \& study visits.
* Informed consent signed.
* History of allergic conjunctivitis
* Current symptoms of allergic conjunctivitis assessed by the investigator

Exclusion Criteria:

* Corneal refractive surgery or contact lens wear within 6 months of this study.
* Current use of Restasis
* Intra-ocular surgery within 6 months or ocular laser surgery within 6 months.
* Pregnant or lactating women.
* Ocular pathology (includes glaucoma and cataract), which could impact results and/or place patient at risk.
A Molecular and Functional Brain Imaging Study in Individuals With Down Syndrome and Healthy Controls Following Single Dose RG1662

This single-center, single-blind, placebo-controlled, parallel-group study with crossover component will evaluate the GABAAalpha5 receptor expression, occupancy and functional connectivity in the brains of individuals with Down syndrome and healthy controls following single dose RG1662. Participants will receive a single dose of placebo before the imaging session (PET and MRI), and a single dose of RG1662 before the second imaging session.


Eligibility Criteria:
Inclusion Criteria:

Healthy controls and individuals with Down syndrome:

* Male and female adults, 18 to 40 years of age
* Body mass index (BMI) 18 - 40 kg/m2 inclusive
* Females of child-bearing potential and males with female partners of child-bearing potential must agree to use two medically approved methods of contraception, one of which must be a barrier method, for the duration of the study and for 4 months after the last study drug administration
* Clinical laboratory values within normal limits or abnormalities considered not significant by the investigator and sponsor; individuals with thyroid disease may be included in the study provided they are euthyroid and stable on treatment for at least one month prior to screening

Individuals with Down syndrome must also meet the following:

* Diagnosis of Down syndrome confirmed by karyotype; subjects may have free trisomy 21 or Robertsonian translocations; mosaic Down syndrome will be excluded
* Individuals must have a parent or other reliable caregiver who agrees to accompany the inidvidual to all clinic visits, provide information about the individual as required by protocol, and be willing to give informed consent

Exclusion Criteria:

* Regular smoker (\>5 cigarettes or equivalent: 3 cigars, 6 cigarillos, 3 pipes per day)
* Concomitant disease or condition or any clinically significant finding at screening that could interfere with, or for which the treatment might interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
* Severe head trauma or CNS infections (e.g. meningitis)
* History of epilepsy or seizures other than benign febrile convulsions of childhood
* Any confirmed significant allergic reactions against any drug, anaphylaxis or severe environmental allergies as judged by the investigator
* Positive for hepatitis B, hepatitis C or HIV infection
* Positive urine test at screening or at follow-up for drugs of abuse, or positive alcohol breath test at screening and prior to dosing
* Previous inclusion in research and/or medical protocol involving nuclear medicine, PET or radiological investigations with significant radiation burden (as defined by protocol)
* Pregnant or lactating women
* Individuals with evidence or meeting clinical diagnosis of dementia
Medicines Gaps Study

The adherence project aims to understand adherence rates and barriers to Direct oral anticoagulants (DOACs) and statins and improve awareness of healthcare professionals on adherence across Leeds.

During the first component of the project, the investigation of rates of non-adherence was classed as service evaluation. The second component of this project, which this IRAS application refers to, will look into patient perspectives and barriers to adherence. Currently, such information is not routinely collected and only requested as part of shorter or longer consultations depending on a pre-defined clinical agenda and with little attention to adherence. Two specific questionnaires have been designed and integrated within the primary care medical records systems. Following invitation for target patients on DOACs and/or statins to respond anonymously, responses to the questionnaire(s) will be stored in their medical records. Data will then be extracted from the two systems \[SystmOne and Egton Medical Information Systems (EMIS)\] using unique system identifiers, that will be pseudonymised at the time of extraction. All patient pseudonymised information (including medical records system identifiers and responses to the questionnaire) will be extracted by the LTHT Researcher-Pharmacist following access provided by each participating General Practitioner (GP) Practice, based on searches built centrally by the Data Quality Team of the Leeds Clinical Commissioning Group (CCG).

Apart from the dissemination of findings based on the questionnaire, a training package for health professionals will be designed and delivered. The aim of the training is to combine and disseminate all findings of the project, raise awareness on real-world non-adherence prevalence and the common barriers to adherence, demonstrate the usefulness of routine adherence estimation and suggest tools to address non-adherence in daily practice. The objectives of this training will also consider the training needs of healthcare professionals locally, as per the healthcare professionals survey that has been designed and circulated.


Eligibility Criteria:
Inclusion Criteria:

* adult patients
* having an active repeat prescription for a DOAC and/or a statin for at least 6 months prior to the date of data extraction
* a diagnosis of atrial fibrillation (AF) for those on a DOAC and of hypercholesterolemia for those on a statin (to justify the preventive nature of the treatments)

Exclusion Criteria:

* Patients with an active repeat prescription for a DOAC and/or a statin for less than 6 months prior to the date of data extraction
Combined Spinal-Epidural Temperature and Duration of Action

The hypothesis is that a combined spinal-epidural drug at refrigerated temperature will have a shorter period of pain relief than that maintained at room temperature. The temperature of the dose of medication will be measure with an infrared thermometer immediately prior (within 5 minutes) to administration.

Subjects will receive a combined spinal epidural medication as per standard of care to treat their labor pain; however, they will be randomized to receive either a dose maintained at room temperature (60-75 degrees F) or one maintained in a refrigerator (\~\<43 degrees F). Duration of action will be done by assessments of pain, vital signs, nausea, itching, bromage and fetal heart rate every 15 minutes until the subject requests additional pain medication to treat their labor pain.

Eligibility Criteria:
Inclusion Criteria:

* \>/= 18 years of age not allergic to medications used to treat labor pain \</= 6cm cervical dilation visual pain score \>/=3

Exclusion Criteria:

* \<18 years of age \> 6 cm cervical dilation non-English speaking subjects
Usage and Plan of Care Changes Due to Drug Screenings

The purpose of this minimal risk, observational survey is to document the accuracy, benefits, and how qualitative and quantitative results affect patients' plan of care.

Pain is the most common reason patients consult primary care providers. According to recent surveys, One in six Americans live with chronic or recurrent pain and pay an estimated $120 billion a year in medical costs in the United States. Oral opioids are the common treatment options for various chronic pains including joint pain, musculoskeletal pain, neuropathic pain and migraines. This narcotic-based management of pain is often associated with undesirable side effects with addictive and potential abuse.

To ensure proper usage of prescribed medications, physicians use drug screens to monitor therapeutic levels and test for presence of illegal drugs or medications that may cause a drug-drug interaction. Upon receiving quantitative or qualitative results from these drug screens, the physician may change the treatment plan for patients to improve efficacy of prescribed medications.

Eligibility Criteria:
Inclusion Criteria:

* Must be a Medical Practioner

  * Medical Doctor (MD)
  * Doctor of Osteopathic (DO)
  * Physician Assistant (PA)
  * Advanced Practice Registered Nurse (APRN)
  * Nurse Practioner (NP)
* Must have a current standard operating procedure that includes obtaining/reviewing medical history.

Exclusion Criteria:

* Government-funded insurance data cannot be included in the study.
RRI Compared With NephroCheckTM to Predict Acute Renal Failure After Cardiac Surgery.

Postoperative acute renal failure is a frequent complication after cardiac surgery. The current practice cannot predict Acute Kidney Injuries (AKI) early enough to reduce a significant kidney assault and prevent an organic dysfunction leading to cortical tubular necrosis.

Several recent studies in cardiac surgery have shown that, both sonographic criteria, such as the Renal Resistive Index (IRR) and urinary biomarkers can predict AKI promptly. These urinary biomarkers are the 'tissue inhibitor of metalloproteinases' (TIMP-2) and the 'insulin-like growth factor binding protein' (IGFBP7). These two proteins are sought noninvasively, directly in the urine, within the same test called 'NephroCheckTM'. These markers, ultrasonographic and biologic, have the advantage of being easy to perform, accessible and seem to have both high sensitivity and specificity to predict AKI promptly after cardiac surgery. Thus, the IRR and the NephroCheckTM test could become essential tests to guide clinicians in determining rapidly whether a patient will develop AKI. However, so far, no study has compared these markers yet.

Therefore, the aim of this prospective observational study will be to compare the effectiveness of the IRR with the NephroCheckTM to predict AKI promptly after cardiac surgery. The secondary outcome will be to determine the threshold of these markers from which patients will be likely to develop AKI


Eligibility Criteria:
Inclusion Criteria:

* Elective patients
* Patients scheduled to receive an extracorporeal circulation
* Patients aged 60 and older
* Patients at risk of postoperative acute kidney injury presenting at least two of the following risk factors:

  * Age \> 60 years.
  * Arteritis defined as severe lower limb arteriopathy or carotid stenosis \> 50%
  * Diabetes
  * Valvular or combined surgery
  * Preoperative intra-aortic balloon pump.

Exclusion Criteria:

* Unable to provide informed consent
* Comatose patients
* Patients with dementia
* Patient who underwent a previous sternotomy
* Chronic renal failure (sCr clearance \< 30 ml.min-1)
* Renal artery stenosis
* Endocarditis
* Emergent surgery
* Nephrotoxic treatment
* Non-sinus cardiac rhythm
Effects of Passive Lower-limb Exoskeleton-assisted Training on Motor and Daily Function Improvements in Older Adults

According to National Development Council estimation, Taiwan is about to enter a super-aged society in 2025, and health promotion for the elderly are critical issues nowadays. The age-related decline in motor function will further affect participation in activities of daily living. In addition to conventional rehabilitation training, robot-assisted training has gained acceptance in clinical rehabilitation. However, robot-assisted trainings were mostly used for motor recovery in patients with neurological disorders, and has not yet been applied to motor function training in community dwelling older adults. This study will examine the effect of passive exoskeleton-assisted gait training on motor function, daily function and self- efficacy in community dwelling older adults, so as to achieve health promotion and develop a new training approach. The purpose of this study will be to determine the comparative effects of passive exoskeleton-assisted gait training and conventional gait training on motor and daily function improvements in older adults.


Eligibility Criteria:
Inclusion Criteria:

1. age ≧ 60
2. normal functional range of motion (within functional limits) in trunk, and leg joints
3. ability to walk continuously for 10 minutes with or without an assistive device
4. Mini Mental State Exam (MMSE) score \> 24, indicating no serious cognitive impairment

Exclusion Criteria:

1. histories of neurological diseases such as dementia, Parkinson\&#39;s disease, and peripheral polyneuropathy
2. recent lower leg injury (6 months) or surgery (1 year) based on self-report
3. taking any over-the-counter drugs, prescription medications, or any substance that may affect gait
4. difficulties in following and understanding instructions
5. enroll in other rehabilitation or drug studies simultaneously -