cyrilzakka/clinical-trials huggingface dataset:
Investigating Fit and Satisfaction of the Prone Positioner

The goal of this clinical trial is to learn about the use of the Prone Positioner in pediatric patients with tracheostomies (trachs). The main question\[s\] it aims to answer are:

* What is the fit and satisfaction of the device?
* Does the device fulfill the goal of allowing infants with trachs participate in tummy time
* What aesthetic feedback will the study team receive on the prone positioner from families, therapists, and nursing staff.

Participants will be placed in the Prone Positioner, they will be monitored for their comfort/satisfaction with use, and how well they are able to be receive ventilation while in the device. Parents of these infants, as well as healthcare providers, will be surveyed on thoughts/suggestions for the Prone Positioner.

A trained member of this study staff will be always present in the patient room during the fit test. For the fit test, a therapist from the study team will takes measurements of the infant and then place the infant in the prone positioner device. At no time will the baby be left alone or unsupported by staff. The study team will assess the physical fit, ease of getting the infant in and out of the device, and the patient's tolerance to being in the positioner.

Parents/guardians will be able to be present while the patient is in the device (if the parents are available and present at the time of fit testing) and immediately following the patient's removal from the device, the parents will be asked to complete a paper survey. The survey will ask for their perceptions of the device, initial reactions, and other qualitative data collected during the fit test. Healthcare providers who are not part of the study team will also be surveyed to obtain their thoughts/opinions on the device as well.

Eligibility Criteria:
Inclusion Criteria:

* Inpatient infants located on the Pediatric Intensive Care Unit (PICU) or (Neonatal Intensive Care Unit (NICU) or being seen in the Vent clinic at Children's Mercy with tracheostomies between the ages of \>44 weeks gestational age to 24 months of age with various size/weights of infants.
* Any race/ethnicity
* English speaker
* Males and females
* Caregivers
* Children's Mercy (CM) Occupational Therapists (OTs), Physical Therapists (PTs), Speech Therapists (STs) who have not seen the new prone positioner device.

Exclusion Criteria:

* Infants \> 24 months of age
* Infants medically unstable as determined by attending physician in the PICU/NICU or Vent Clinic
* Infants with recent cardiac or abdominal surgery who have precautions or complications related to their surgery.
* Infants with weightbearing restrictions/fractures in their upper extremities.
* Non-English speakers \* Wards of the state
Population Pharmacokinetics, Effectiveness and Safety of Cefuroxime in Neonates

Cefuroxime is a time-dependent antibiotic that is used to treat bacterial infections. However, population pharmacokinetic，effectiveness and safety data for cefuroxime in neonates are lacking. The aim of this study was to assess the population pharmacokinetics, effectiveness, and safety of cefuroxime in neonates.


Eligibility Criteria:
Inclusion Criteria:

* Age: postnatal age ≤28 days;
* Cefuroxime used as part of antimicrobial treatment;
* Parental written consent.

Exclusion Criteria:

* Expected survival time less than the treatment cycle;
* Receiving other systemic trial drug therapy;
* Other factors that the researcher considers unsuitable for inclusion.
A Study to Determine if Caffeine Accelerates Emergence From Propofol Anesthesia

At present clinicians have no way to reverse anesthesia. Patients wake when their bodies clear the anesthetic. Most people wake quickly, but some do not. All patients have memory and other cognitive problems after waking from anesthesia. In studies on animals, the investigators observed that caffeine caused rats to wake much more rapidly from propofol anesthesia. This was true for all the animals tested. The investigators would like to see if this holds true in humans. Will caffeine accelerate waking from anesthesia? Will it reverse the cognitive deficits associated with anesthesia, after waking?

The propose investigators carrying out a modest trial with 8 test subjects. Each volunteer will be anesthetized twice. Each volunteer will be anesthetized one time and receive an infusion of saline (placebo control), without the aid of any other drugs and the other time the volunteer will receive an infusion of a relatively low dose of caffeine. The order of saline versus caffeine will be randomized and the study will be done in a double blind manner. We will determine whether emergence from propofol anesthesia will be significantly accelerated by the caffeine infusion. And whether any adverse events are observed.


Eligibility Criteria:
Inclusion Criteria:

1. Age 25-40.
2. Male.
3. Normal healthy subject without systematic diseases or conditions.
4. Metabolic Equivalents of Functional Capacity \>= 5.
5. Low risk for Obstructive Sleep Apnea (OSA) based on the screening test (STOP-bang score established by American Society of Sleep Apnea): Yes to \> 3 items- high risk of OSA
6. No History of Arrhythmia (Baseline EKG will be obtained during the history and physical session), seizure, liver and kidney diseases.
7. BMI \< 30 kg/m2.
8. No history of prior difficulty with anesthesia.
9. No personal or family history of malignant hyperthermia.
10. No history of any mental illness.
11. No history of drugs or alcohol abuse (urine drug screens required).
12. Subjects capable of giving consent.
13. Living less than 30 miles away from University of Chicago.
14. No history of seizure disorders.
15. No history of head trauma.

Exclusion Criteria:

1. Age \<25 or \>40.
2. Female.
3. ASA physical status \> 1 (normal healthy subject without systematic diseases or conditions)
4. Metabolic Equivalents of Functional Capacity (METs) \< 5.
5. High risks for Obstructive Sleep Apnea (OSA) based on the screening test (STOP-bang score established by American Society of Sleep Apnea): Yes to \> 3 items- high risk of OSA
6. History Arrhythmia (Baseline EKG will be obtained during the history and physical session), seizure, liver and kidney diseases
7. BMI\>30 kg/m2.
8. Prior difficulty with anesthesia.
9. Personal or family history of malignant hyperthermia.
10. History of any mental illness.
11. History of drugs or alcohol abuse (urine drug screens required)
12. Subjects not capable of giving consent
13. Living more than 30 miles away from University of Chicago.
14. History of seizure disorders.
15. History of head trauma.
Effect of the Duration of Preoperative Fasting on Hypotension Induced by General Anesthesia in the Elderly Person

This study aims to determine if prolonged fasting represents an independent risk factor for hypotension during induction of general anesthesia in the elderly.

Preoperative fasting aims to reduce the risk of adverse events (eg, inhalation), but may be responsible for dehydration whose consequence is a major hypotension. This problem of hypotension is important because it (MAP \<55 mmHg) is directly correlated to the occurrence of pejorative events on the cardiac and renal level and even more so that the duration of the hypotension is long.

Eligibility Criteria:
Inclusion Criteria:

* Risk Score anesthetic ASA I-III
* Patients ≥ 70 years
* Suffering from a femoral neck fracture to be treated surgically:

  * either through prosthesis,
  * either by intramedullary nailing (gamma nail)

Exclusion Criteria:

* Risk Score anesthetic ASA IV
* Patient on Angiotensin Converting Enzyme (ACE) inhibitors or ARBs (ARA2) within 10 hours before surgery
* Obesity (BMI\> 35) or weight \<40kg
* Need to make a rapid sequence induction
* Inability to achieve the femoral block (standardization of induction) or patient refusal with respect to the technique.
Sorafenib VS TACE in HCC Patients With Portal Vein Invasion

The investigators are going to compare the therapeutic effect of sorafenib and transarterial chemoembolization in advanced hepatocellular carcinoma with major branch of portal vein invasion.

TACE is an established therapy for patients with unresectable hepatocellular carcinoma (HCC) and has been shown to significantly improve survival in these patients compared to no treatment. Moreover, TACE can be performed safely and may improve the overall survival of patients with HCC and major branch of portal vein invasion. Sorafenib, already approved for HCC, could lead to significantly improvement in tumor control and survival in patients with advanced stage HCC. So far there are no head to head comparison reports about the efficacy of Sorafenib and TACE. Here the investigators evaluate the efficacy of sorafenib and TACE in advanced HCC with major branch of portal vein invasion.

Eligibility Criteria:
Inclusion Criteria:

1. 80 \> Age \>= 18 years.
2. Child-Pugh class A (class B could be included when Childs score is 7).
3. Hepatocellular carcinoma with major branch of portal vein invasion on dynamic CT or MRI

   * not only newly diagnosed treatment-naive patients,
   * but also HCC patients previously treated with other therapies in case of development of major branch of portal vein invasion
4. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements:

   * White blood cell counts (WBC) \>= 2,000 /μl, Absolute neutrophil count (ANC) \> 1,200/μl
   * Hemoglobin \>= 8.0 g/dl
   * Platelet count \> 50,000/μl
   * Serum creatinine \< 1.7 mg/dl
   * Total bilirubin =\< 3.0 mg/dl
   * Prothrombin Time (PT)-international normalized ratio (INR) =\< 2.3 or Prothrombin Time (PT)-sec =\< 6 sec
5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.

Exclusion Criteria:

1. Child-Pugh score \>= 8.
2. Age \< 18 or \>= 80 years.
3. ECOG Performance Status \>= 3.
4. Recipient of living donor or deceased donor liver transplantation
5. Patients unable to understand the contents of informed consent or refuse to sign the informed consent.
6. Patients with evidence of uncontrolled or severe medical conditions requiring treatment.
IMMEDIATE IMPLANT With Different Types of Membranes

forty patients will be selected from the outpatient's clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University for replacement of non-restorable tooth in posterior mandibular area.

Patients' Grouping:

The patients will be randomly divided into two equal uniform groups each consists of 20 patients:

Group A:

20 patients with non-restorable mandibular molar tooth will be treated with an immediately placed dental implant in conjunction with a dentin-derived membrane from the extracted tooth.

Group B:

20 patients with non-restorable mandibular molar tooth will be treated with an immediately placed dental implant in conjunction with extended platelet rich fibrin membrane.


Eligibility Criteria:
Inclusion Criteria:

* Age above 18 years
* Non-restorable mandibular molar tooth that needs dental extraction \& guided bone regeneration for immediate implant placement.
* Acceptable inter-arch space for the future prosthesis.
* Patient medically free from systemic diseases that absolutely contraindicate implant surgery.
* Cooperative patient with high motivation and acceptable oral hygiene.
* Free from history of bruxism / parafunctional habits.

Exclusion Criteria:

* Local and / or systemic conditions that interfere with the procedure.
* Smokers.
* Pregnancy.
* Uncooperative patients.
* Patient had undergone in the past 12 months radiation therapy to the head and neck area.
The Efficacy of Targeted Training on the Postural Control and Gross Motor Function in Children With Cerebral Palsy

The project aims to test the effectiveness and explore the possibility of performing a novel therapeutic approach, targeting to increase strength and coordination around the trunk, giving a more active and functional seating and head control in those children with cerebral palsy (CP) who are wheelchair users. The project will also try to determine the muscle physiological effect of treatment using indirect measures of strength in the spinal musculature.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of CP made by a neuro-pediatric physician experienced in assessment and diagnosis of CP
* GMFCS level III, IV and V,
* the child cannot walk without assistance,
* age 2-15 year,
* no joint deformity or contracture around the "Targeted" joint
* not a candidate for surgery or other medical treatment that affects motor skills while participating in the project
* trunk control problems.

Exclusion Criteria:

* uncontrolled epilepsy
* surgery within 12 months of the study start
* Botulinum toxin within 2 months of study start
* Lack of personnel resources to treat the child at their school/kindergarten
Direct Measurement of Proinsulin Clearance in Humans

Researchers are trying to determine how quickly proinsulin is cleared from the circulation.

proinsulin clearance is necessary to determine the rate of secretion into the circulation

Eligibility Criteria:
Inclusion Criteria:

* Weight-stable, non-diabetic subjects from Biobank participants at Mayo Clinic, Rochester

Exclusion Criteria:

* Age \< 25 or \> 65 years (to avoid studying subjects who could have latent type 1 diabetes, or the effects of age extremes in subjects with normal or impaired fasting glucose).
* HbA1c ≥ 6.5%
* Use of glucose-lowering agents.
* For female subjects: positive pregnancy test at the time of enrollment or study
* History of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy.
* Active systemic illness or malignancy.
* Symptomatic macrovascular or microvascular disease.
* Hormone replacement therapy \>0.625 mg premarin daily
Mobile Phone Daily Alarm To Improve Compliance Of Intranasal Corticosteroid Among Allergic Rhinitis Patients.

This is a randomized controlled trial to compare the compliance of allergic rhinitis patients towards intranasal steroids between those who use mobile daily alarm reminder and those who do not.

In this single blinded RCT, adults with allergic rhinitis are randomized into either he intervention or control arm. The intervention involves installing an alarm with a prerecorded nmessage "Have you take your intranasal steroids" which will automatically ring every day on the patients mobile phone. The control arm do not have any alarm set up. Both groups are offered counseling and education regarding the importance of compliance to intranasal steroid upon recruitment. Daily reminder to take medication may eliminate reason for forgetting medication schedule, hence, improve compliance towards INCS among patients with allergic rhinitis. This study aims to assess the effectiveness of using daily mobile alarm on patient's compliance towards INCS.

Eligibility Criteria:
Inclusion Criteria:

* • Patients aged 15 years old to 60 years old with persistent AR

  * Positive SPT towards DF, DP, BT, cockroach, Aspergillus, Cat fur
  * Own and able to operate functioning mobile smartphone with built in alarm
  * Able to understand simple instructions
  * Patients who can read in English and Malay
  * Newly diagnosed AR or previous patients who only take intranasal corticosteroid less than 4 times per week

Exclusion Criteria:

* • Patients on immunotherapy

  * Patients with mild intermittent AR
  * Pregnant patients
  * Patient with psychiatric illness
  * Patients with gross anatomical obstruction (severe DNS, gross polyposis, nasal tumour)
  * Chronic rhinosinusitis(CRS) with or without nasal polyposis
  * Patients who have adverse reaction towards INCS
  * Patients with severe hearing loss
MRI on Persons With Mutations in POMT2 Gene (LGMD2N)

POMT2 mutation is known to cause Walker Warburg Syndrome and Muscle-Brain-Eye syndrome. Recently it has been connected to limb girdle muscular dystrophy (LGMD), a disorder characterized by muscle weakness and atrophy of the proximal muscles of the shoulder and pelvic girdles. LGMD is classified based on its inheritance pattern and genetic cause into more than 31 different types. LGMD with POMT2 mutations is a new phenotype - type 2N. Very few patients with the LGMD2N phenotype has been reported. In this study, the investigators examine five new cases with the LGMD phenotype. The primary aim is to examine the muscle involvement using MRI.


Eligibility Criteria:
Inclusion Criteria:

* Persons with genetically verified mutations in POMT2

Exclusion Criteria:

* All contraindications for undergoing an MRI scan
RCT on the Treatment of Menopausal Syndrome With Chinese Medicine

This is a double-blinded, randomized, placebo-controlled clinical trial. Subjects will be randomly assigned to the treatment group (Modified Guizhi Fuling granules) or placebo group (Placebo granules) for 8 weeks. Outcomes will be measured at week 8 and week 12.

Menopausal syndrome is a series of symptoms caused by ovarian follicles degeneration that occurs before or after menopause. These symptoms include central nervous system-related disorders (such as hot flashes, insomnia, depression, anxiety, etc.); metabolic, weight, cardiovascular and musculoskeletal changes; urogenital and skin atrophy; and sexual dysfunction.

Some previous studies have investigated the possibilities of using traditional Chinese medicine (TCM) for the treatment of menopausal syndrome. However, due to the limitations of previous clinical research, more evidence is required to support the efficacy of TCM treatment. Therefore, we propose to conduct a randomized, double-blinded, placebo-controlled clinical trial here, with the hope of objectively assessing the efficacy and safety of using TCM to treat menopausal syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Female subjects with age between 40 and 60 years old;
* For those who have symptoms of primary menopause (irregular menstruation lasting for more than 6 months, or absence of menstrual periods for more than 3 months)
* The score of the physical symptoms in Greene Climacteric Symptom Score (GCS) is 6 or above (average level);
* Have moderate level (affecting certain level of daily activity) or severe (cannot carry out daily activity) hot flashes, defined as transient sensations of heat, sweating, flushing, anxiety and chills lasting for 1-5 minutes;
* Diagnosed Deficiency of Kidney essence and static blood in Lower Jiao by Chinese medicine practitioner
* Agreed to receive Chinese medication or placebo for 2 months upon randomization.

Exclusion Criteria:

* The menopausal syndrome caused by surgical operations or medications (such as chemotherapy, gonadotropin-releasing hormone agonists, etc.).
* Have received estrogen treatment in the past 2 months;
* Have received any medication for treating menopause in the past month, including herbs, non-prescribed drugs, supplements, or change of diet to consume more legumes;
* Known serious emotional, mental or psychological disorders that may affect the study;
* During pregnancy, pre-pregnancy period, or lactation period;
* Known history of allergy to any traditional Chinese medicine;
* Have received anticoagulant or antiplatelet drugs in the past month;
* Known history of some certain serious medical disease, such as cardiovascular disease, liver or renal dysfunction, diabetes, cerebrovascular disease, blood disorders, with unstable conditions;
* Chinese medicine pattern combined with damp phlegm or damp heat, or only deficiency of Yin blood or absence of static blood pattern.
A Study to Evaluate the BrainPort Vision Device in Individuals Blinded by Traumatic Injury

The BrainPort V200 Device is a wearable, non-surgical, prosthetic device intended for people who are profoundly blind. The BrainPort V200 translates images captured by a digital camera into electro-tactile stimulation presented on the user's tongue to perceive shape, size, location, and motion of objects within the environment. The purpose of this study is to evaluate the safety and functional performance of the BrainPort V200 device in individuals who have been medically documented as blind, light perception or worse, due to a traumatic injury (cortical or ocular).


Eligibility Criteria:
Inclusion Criteria:

1. A minimum age of 18 years at enrollment.
2. A documented vision diagnosis of light perception or worse bilaterally.
3. Blinded by traumatic injury (i.e., ocular or cortical trauma).
4. Minimum post 12 months diagnosis of blindness.
5. Previous completion of conventional rehabilitation such as orientation and mobility training with a cane or guide dog.
6. Ability to read (or have read to them) and understand study documents and procedures.
7. Ability to provide valid feedback regarding use of the BrainPort device.
8. Access to an accessible computer and internet connection.
9. Willing and able to complete all questionnaires, telephone conferences, device training, and study procedures required by the protocol, after completing an orientation period with the device.
10. Ability to operate a tablet computer.

Exclusion Criteria:

1. Current oral health problems determined by the participant's medical history and an examination of the oral cavity performed by study personnel.
2. History of injury to the tongue resulting in impaired sensation of use of the tongue.
3. Visible open lesions, cold sores, abrasions, blisters, or rash on the tongue, numbness or lack of feeling of the tongue.
4. Piercings on the tongue.
5. Recent or planned oral surgery and/or dental work in the past three months (does not include routine dental health exams/cleanings).
6. Known neuropathies of the tongue or tactile system.
7. History of seizures or epilepsy.
8. If female, pregnant or breast feeding by self-report. Women of child bearing potential must agree to use appropriate birth control to prevent pregnancy for the duration of the study.
9. People with implanted medical devices (i.e., pacemaker, deep brain stimulator, cochlear implant).
10. Any hearing impairments which prevents hearing the device announcements.
11. Any cognitive disabilities (such as Alzheimer's disease), as determined by medical history and/or the Telephone Inventory Cognitive Screening (TICS).
12. Participation in any other clinical trial or research while my confound results in either study.
13. Known allergy to nickel, gold, or any component of stainless steel.
14. Any medical condition that would interfere with performance on the assessments.
15. The Site Principal Investigator does not deem the candidate to be suitable for the study for other reasons not listed above.