cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Modified Bite-Block for Invasive Imaging Procedures

The purpose of this study is to compare a modified bite block with standard bite block during transesophageal echocardiography procedures in patients who are either sedated or under general anesthesia.

These dental protector devices are class I devices which are exempt from the FDA 510(k) premarket notification requirements.

Bite block is a single-use medical device used to keep the mouth open during invasive imaging procedures and prevent the patient from biting the imaging probe.

The purpose of this study is to compare a modified bite block with standard bite block during transesophageal echocardiography exam procedures in patients who are either sedated or under general anesthesia.

The commercially available bite blocks are almost exclusively made of hard plastic that does not conform well to the patient's mouth with additional protrusions used to secure the bite block in place that have the potential to cause patient injury. Hard plastic is used to prevent patient from biting down on the imaging probe while side protrusions are used to strap the bite block down to prevent dislodgment.

Modified bite block is made of softer material with improved mouth fit and no need for strapping the bite block to keep it in place. Softer material is more comfortable while the designs mimics mouth guard used in dentistry to protect patient's teeth and keep the bite block in place while sleeping.

The specific aims of this project include:

* assessment of patient comfort during invasive imaging procedure
* assessment of provider satisfaction with the bite block
* assessment of patient lip/gum/teeth injury after bite block use
* assessment of imaging probe damage after procedure
* assessment of bite block's ability to stay in place during procedure

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Undergoing stand-alone transesophageal echocardiography exam under sedation or general anesthesia
* Undergoing procedure that requires transesophageal echocardiography exam during the procedure under general anesthesia
* Cardiology and cardiac anesthesiology echocardiographers performing transesophageal echocardiography exam who wish to participate

Exclusion Criteria:

* Less than 18 years of age
* Any procedure that does not require transesophageal echocardiography exam during the procedure
To Evaluate the Immunogenicity and Safety of Two Different Immunization Schedules of Rabies Vaccine (Vero Cell)

To evaluate the safety and immunogenicity of lyophilized human rabies vaccine (Vero cell) developed by Hualan Biological in healthy people aged 9 to 65 years with two different immunization schedules.

The trial to assess the rabies vaccine (Vero cells) in healthy group of 9 \~ 65 years old after inoculation, the first dose after 14 days and 14 days after inoculation 5 agent group turn antibody positive rate of bad effect on 5 agent in the control group; The safety profile, seroconversion rate, and geometric mean concentration of the four-dose vaccine were noninferior to those of the five-dose regimen at 14 days after the first dose. More people aged 9-65 in the first agent free after 7 days, 14 days and 14 days after inoculation, 5 patients and 5 doses in the control group, four patients and 5 doses group antibody positive rate, GMC and GMC growth multiples have differences. To evaluate whether the seroconversion rate of subjects in the 4-dose experimental group reached 100% 14 days after the whole course of vaccination.

Eligibility Criteria:
Inclusion Criteria:

* 9 to 65 years old healthy residents;
* volunteered for the experiment and signed informed consent;
* the subjects or their guardians can comply with the requirements of the clinical trial protocol;
* have not received rabies vaccination at any time;
* nearly six months has not been mammals bite, scratch;
* not participating in clinical trials of other drugs;
* No use of human immunoglobulin or other products in the past six months.

Exclusion Criteria:

First needle exclusion:

* have allergies, convulsions, seizures, mental and nervous system, such as history, or family history of epilepsy;
* Allergic to the main ingredient of the investigational vaccine;
* known to people with poor immune function damage or the tumor, spleen;
* Axillary temperature \>38.0℃ within 7 days due to acute febrile illness;
* Patients with axillary body temperature \> 37.0℃;
* Severe chronic diseases such as congenital malformation, developmental disorder or severe cardiovascular disease, diabetes mellitus, hypertension that cannot be stabilized by drugs, liver and kidney diseases, and malignant tumors;
* patients with acute and chronic infectious diseases, active infections, severe asthma, infectious skin diseases;
* pregnant and lactating women; Any circumstances that the investigator believes may affect the assessment of the trial.

Subsequent needle exclusions:

* any serious adverse event causally related to vaccination;
* new findings that meet the "first dose exclusion criteria";
* the researchers think that may affect test evaluation of any situation.
Systemic Fluoride Bioavailability From Toothpastes Containing Calcium Carbonate or Silica as Abrasives

The risk of dental fluorosis development is related to the systemic exposure to fluoride during enamel formation. Currently, diet and fluoride toothpastes are the main sources of fluoride to children at the age-risk for fluorosis development. However, when estimating the risk of fluorosis from toothpaste inadvertently ingested, it has not been considered the systemic fluoride bioavailability. Since some toothpaste formulations may contain part of fluoride as insoluble salts, the hypothesis behind this study is that only soluble fluoride in toothpastes would be absorbed when they are inadvertently ingested. To test that, adult volunteers will ingest a standardized dose of total fluoride from commercially available toothpastes, which present different concentrations of soluble fluoride. Fluoride systemic bioavailability will be assessed by the release of fluoride in saliva up to 3 hours after ingestion (as an indicator of blood fluoride) and by urinary fluoride excretion.


Eligibility Criteria:
Inclusion Criteria:

* Good general health
* Good oral health
* Normal salivary flow rate

Exclusion Criteria:

* Gastric disorders
* Renal disorders
A Study of AK0529 in Infants Hospitalized With RSV

This study will assess the safety, tolerability, pharmacokinetics (PK) and anti-viral effect of single dose of AK0529 in infants hospitalized with respiratory syncytial virus (RSV).

This is a open-label Phase 1b study to evaluate the safety, tolerability, pharmacodynamics and Pharmacokinetics of AK0529 in hospitalized RSV infected infants age from 1 to 24 months.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects of any race or ethnicity with an age adjusted for any prematurity of ≥1 month and ≤24 months.
* Diagnosis of RSV infection by virological.
* Subject must weigh \>3 kg at screening.
* Must have provided written informed consent for the subject to participate.
* For patients aged \<12 months, and occipitofrontal head circumference (OFHC) within the normal range for age and gender.

Exclusion Criteria:

* The subject has taken, is currently taking or requires any restricted medications.
* Subject is known to be HIV-positive (or the mother, if the potential subject is a child aged \<6 months).
* Participation in an investigational drug or device study within 30 days prior to the date of screening.
* Requires vasopressors or inotropic support at the time of enrollment.
* Concurrent gastrointestinal conditions that could, in the opinion of the investigator, prejudice absorption of the Investigational Medicinal Product (e.g. protracted vomiting, malabsorption syndrome, a history of necrotising enterocolitis with consequent short gut syndrome).
* Bronchopulmonary dysplasia or chronic lung disease requiring assisted ventilation at the time of enrollment.
* Diminished ventilatory reserve at risk for hypercapnia (e.g. pulmonary hypoplasia, sequestration syndromes, cystadenomatoid malformation, a history of surgery for diaphragmatic hernia).
* Left to right shunt meriting corrective therapy.
Assess the Safety and Pharmacokinetics of Ascending, Multiple Oral Doses of SPD489 in Adults With Schizophrenia

This is a multiple ascending dose study; the purpose of this study is to examine the safety, tolerability and pharmacokinetics (levels of drug in the blood) of SPD489 in Schizophrenic Patients who are currently maintained on a stable dose of an antipsychotic medication.


Eligibility Criteria:
Subjects must be diagnosed with schizophrenia, on a stable dose of an antipsychotic and not have any cardiac risk factors
Efficacy And Safety Of PF-00885706 For The Relief Of Symptoms In Subjects With Gastro-esophageal Reflux Disease (GERD)

To understand the dose-response characteristics of PF-00885706 for efficacy in terms of symptomatic relief when used as add-on treatment to esomeprazole 20mg (standard proton pump inhibitor \[PPI\] treatment), in subjects with gastro-esophageal reflux (GERD) who have inadequate relief with PPIs.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with a diagnosis of GERD who fulfill the following criteria:

who have symptoms for least six months prior to enrollment; who are currently on daily treatment with a PPI and have been on such treatment for at least 3 months; whose symptoms are persistent, troublesome and that include heartburn and/or regurgitation as their predominant symptoms despite treatment with a PPI; who are seeking relief of persistent symptoms.

Exclusion Criteria:

* Subjects with erosive esophagitis - An endoscopy within the last 5 years is required to verify absence.
* Subjects with any esophageal or gastric diseases/conditions that may contribute to their GERD symptoms.
* If female; pregnant, lactating or positive serum or urine pregnancy tests.
Stress Radiography for Pelvic Ring Injuries

The primary aim of this investigation is to prospectively and clinically validate a novel, reproducible method of quantitative application of compressive stress to a LC1 pelvic ring injury of indeterminate stability for the purpose of assessing quantitative pelvic ring displacement.

patients will receive a diagnostic intervention with multiple x-rays. These x-rays will be taken as different levels of force are applied to the pelvis. This will be used to determine instability as an indication for surgical intervention to stabilize the pelvic ring.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Acute emergency department admission or transfer to Los Angeles County + USC Medical Center
* Presentation within 3 weeks of injury
* Blunt or blast mechanism of traumatic injury
* Lateral compression pelvic ring injury with unilateral incomplete disruption of the posterior arch (OTA/AO 61B1.1/2.2; Young Burgess LC1) on radiographs and/or computed tomography scan of the pelvis obtained per routine care
* LC1 pelvic ring injuries occurring in isolation are virtually never associated with hemodynamic instability or critical patient condition
* Stress examination of LC1 pelvic ring injury is standard of care
* Patient must speak either English or Spanish

Exclusion Criteria:

* Volume expanding pelvic ring injury (Young-Burgess APC-2 and 3, LC-3, vertical shear, and combined mechanism of injury (CMI) (Tile B and C patterns; OTA codes 61-B and 61-C).
* Volume expanding pelvic ring injury injuries represent the types of pelvic ring disruption responsible for pelvic hemorrhage and hypotension and are correlate with patient hemodynamic instability as well as critical injuries
* Volume expanding pelvic ring injury injuries warrant stabilization with circumferential pelvic compression.
* Patients with volume expanding pelvic ring injury are not clinically appropriate for this study.
* Hemodynamic instability or hypotension angioembolization (AE), preperitoneal pelvic packing (PPP), or Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) to obtain or maintain hemodynamic stability
* Bladder, vaginal, rectal, colonic, or other abdominal or pelvic organ injury precluding safe application of circumferential pelvic compression device
* Patient likely to have severe problems with maintaining follow- up due to at least one of the following:
* Patient has been diagnosed with a severe psychiatric condition
* Patient is intellectually challenged without adequate family support
* Patient lives outside the hospital's catchment area
* Follow-up is planned at another medical center
* Patients who are prisoners or homeless
Phase 1 Single Ascending Dose Study to Evaluate Safety, Tolerability and Pharmacokinetics of KBP-5074

This single ascending dose (SAD) study in healthy subjects will evaluate the safety, tolerability and pharmacokinetics of KBP-5074. PK/PD (plasma aldosterone, serum potassium and urine albumin levels) relationships will be explored to support the selection of dosing regimens of KBP-5074 that are suitable for the Phase 2 dose-finding study to evaluate the efficacy, safety and tolerability of KBP-5074 in patients that could slow the progression of nephropathy as well as control hypertension.

This is an open-label, parallel-group, dose-escalation study to evaluate the safety, tolerability and pharmacokinetics of KBP-5074 following a single dose administration of KBP-5074 with and without food. The study includes 2 parts.

Part 1: Pharmacokinetics from each dose cohort will be characterized before initiation of dosing in the subsequent cohorts. Eight subjects in each dose cohort will receive active drug. The total number of cohorts will be up to 5. Extensive PK samplings will be collected prior to and following administration of single dose of KBP-5074.

Part 2: A separate panel of 6 subjects will receive a single dose of KBP-5074 under fed conditions. Extensive PK samplings will be collected prior to and following administration of single dose of KBP-5074 under fed conditions.

Serum and plasma samples for pharmacodynamic markers (plasma aldosterone and serum potassium levels) will be collected at pre-dose and postdose in both Part 1 and Part 2.

The urine samples will be also used for quantitative determination of urinary albumin in both Part 1 and Part 2.

Safety assessments will include monitoring of adverse events (AEs), vital signs (blood pressure, pulse rate, respiratory rate and oral temperature), clinical laboratory findings, 12-lead electrocardiograms (ECGs), and physical examination findings.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) 19 ≤ BMI ≤ 30 kg/m2, no significant medical history, normal renal function and in good general health

Exclusion Criteria:

* Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity; A history of prescription drug abuse, or illicit drug use within 6 months prior to screening
A Study of GANFORT® UD in Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT) in a Medical Setting

The study will evaluate patients diagnosed with POAG or OHT who are switched to GANFORT® UD (unit dose of fixed combination bimatoprost and timolol) therapy for medical reasons in accordance with physician standard clinical practice. All treatment decisions lie with the physician.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with primary open-angle glaucoma or ocular hypertension
* Previously prescribed intraocular pressure (IOP)-lowering medication with insufficient IOP control and is now being switched to GANFORT® UD for medical reasons

Exclusion Criteria:

* None
The Effect of Gastric Bypass Surgery on Diabetes

This study will investigate the effects of gastric bypass surgery on type II diabetes. The study will recruit patients with type II diabetes having Roux-en-Y gastric bypass, patients without type II diabetes having Roux-en-Y gastric bypass, and control subjects (patients having gastroscopy, but no surgery). Targeted enrollment is 30 patients per group. Samples of intestine are taken prior to surgery in gastroscopy, during surgery, and 6 months after surgery during gastroscopy. Meal test with incretin measurements, and feces and blood samplings are performed before and after surgery

Hypotheses are:

* The pathogenesis of type II diabetes is linked to changes in the expression of intestinal endocrine cells
* The changes in the incretine excretion after the gastric bypass surgery partly explain the amelioration of type II diabetes
* The oxidation of lipoprotein is diminished after the gastric bypass surgery slowing the development of atherosclerosis
* The immunologic functions of the intestine are changed by the gastric bypass surgery attenuating systemic inflammation
* The gastric bypass surgery changes cholesterol and bile acid metabolism
* The gastric bypass surgery changes the fecal microbiota

Primary end points are:

* Changes in the amounts of endocrine cells in ventricle, duodenum and jejunum
* Changes in the incretine secretion studied with liquid meal test
* Changes in the oxidation of lipoproteins
* Changes in the immunologic markers in ventricle, duodenum and jejunum
* Changes in the amounts of phytosterols, cholesterol metabolites and bile acids
* Changes in fecal microbiota


Eligibility Criteria:
Inclusion Criteria (patients with surgery):

* Patients having Roux-en-Y gastric bypass (according to clinical guidelines)
* Age: 18-65 years

Inclusion Criteria (control patients without surgery):

* Patients having gastroscopy (for various clinical reasons)

Exclusion Criteria:

* Diabetes (applies for control patients)
* BMI over 30 (applies for control patients)
* Insulin treatment
* Oral corticosteroid treatment
* Chronic inflammatory disease
* Coeliac disease
* Malignant disease
Quality of Life After Enhanced Recovery Protocol for Colorectal Surgery

The aim of the study is to investigate the quality of life and satisfaction of patient who underwent colorectal surgery using an enhanced recovery protocol when back home.

In this retrospective study patients will be telephoned and asked to answer a questionnaire.

Since October 1st 2015, our center has been labelled reference center for colorectal surgery using Enhanced Recovery Protocol (ERP) by GRACE (Groupe francophone de Rehabilitation après ChirurgiE; a francophone counterpart of ERAS® society). In case of ERP, the quality of life when the patient is at home is not well known. Some argue that patient might experience discomfort and lack of autonomy, particularly elderly patient if discharged home too quickly.

In this study, the investigators will call our patients introduced in the database of GRACE to assess the quality of life and patient satisfaction concerning our ERP. Eight domains will be investigated: information, stress, feelings when discharged home, pain, fatigue, autonomy, feeding problems, and satisfaction.

When analyzing the results the investigators will pay a particular attention to elderly patients (age \> 70 yo) to determine whether these experience more difficulties as compared to younger patients.

Eligibility Criteria:
Inclusion Criteria:

* all patients included in our GRACE database

Exclusion Criteria:

* No exclusion criteria
Kintsugi Voice Device Study

The Kintsugi Voice Device Pilot Study is a two arm pilot diagnostic accuracy study. Eligible enrolled participants will complete the Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7) instruments, as well as complete a remote video-recorded Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders-5 (SCID) with a trained psychiatrist.

This study seeks to evaluate the ability of the Device to aid clinical assessment for depression and anxiety by comparing its output with the established diagnostic standard consisting of a diagnosis made by a specialist clinician based on DSM-5 criteria.

The order of the assessments will be randomized. Audio captured during the SCID interview will be inputted into a machine learning model to determine the diagnostic accuracy of the Kintsugi Voice Device.

This is a prospective study of up to 100 subjects, ages \>22 years of age.

The study is striving for a 50%/50% split of subjects who have depression and/or anxiety and subjects who do not have depression and/or anxiety.

Eligibility Criteria:
Inclusion Criteria:

* Subjects greater than or equal to 22 years of age at the time of informed consent
* Participants must be able to read, understand, and sign the Informed Consent Form
* Access to a laptop, smartphone, tablet, or other Device with a functioning microphone
* Participants must be willing to be videotaped as part of the study
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Fluency in English
* Availability for the duration of the study
* The participant must reside within the state of California

Exclusion Criteria:

* Any impairment that would prevent participants from completing an online survey and/or engage in clinician assessment interviews (e.g., visual impairment, motor impairment, hearing impairment, acute intoxication)
* Any known history of neurodegenerative or Central Nervous System disorders
* Any known history of schizophrenia, psychosis, or severe cognitive deficits
* Any known presence of disorders that may lead to false signal of depression or anxiety including Multiple Sclerosis, Amyotrophic Lateral Sclerosis, Parkinson's Disease, Stroke, Traumatic Brain Injury
* Presence of voice disorders that may impact vocal cords such as acute or chronic laryngitis, vocal cord paresis or paralysis, or spasmodic dysphonia
* Any known history of vocal cord injury or cerebrovascular accident or head trauma with residual dysarthria in the past year
* Past or active heavy smokers if there is impact on the vocal cords
* Any known history of congenital deafness
* Subjects who do not speak English
* Subjects who do not live in the United States
* Subjects who have previously participated in any Kintsugi-sponsored study
Prospective Randomized Comparison of Bipolar Hemiarthroplasty and Total Hip Arthroplasty With Large Femoral Heads for the Treatment of Displaced Intracapsular Femoral Neck Fractures in the Elderly

The purpose of this study is to compare hemiarthroplasty (HAP) with total hip arthroplasty (THA), performed by trained arthroplasty surgeons with the use of large femoral heads for the treatment of displaced femoral neck fractures in mobile independent elderly patients, to determine the impact of these surgical options on the short term functional outcomes and complication rates, namely dislocation and the need for further surgery.

This is a single-blinded prospective randomized clinical trial comparing functional outcome and complication rates of 40 patients treated with all cemented THA to a control group of 40 patients treated with cemented bipolar HAP, in a 2 years followup.

The primary endpoint is the Oxford hip score (OHS) at last followup as a measure of functional outcome. Secondary endpoints include the SF-36 score, walking distance and rates of postoperative dislocation, component loosening, need for revision and postoperative mortality.


Eligibility Criteria:
Inclusion Criteria:

* 1. Acute femoral neck fracture.
* 2. Age between 70 and 90 years old.
* 3. Independent community ambulator (more than 0.5km, without the aid of another person. The use of a cane is permitted) prior to fracture.
* 4. Abbreviated mental test score \> 6 .

Exclusion Criteria:

* 1. Pathological fracture (excluding osteoporosis).
* 2. Rheumatoid arthritis.
* 3. Symptomatic arthrosis of the involved hip.
* 4. Neurological disorder that may significantly influence walking ability and/or tendency to dislocate.
* 5. Chronic corticosteroid use.
* 6. Concomitant other fracture.
* 7. Very high surgical risk.