cyrilzakka/clinical-trials huggingface dataset:
Geriatric Emergency Department Fall Injury Prevention Project

This prospective randomized study will assess an emergency department (ED) based prevention strategy in geriatric patients at high risk for recurrent falls and injury. Falling is a major health hazard in older adults with a number of proposed but unproven protocols to prevent fall-related injuries. This study proposes to study one of these strategies, the CDC's Stopping Elderly Accidents, Deaths and Injuries program (the STEADI Program).

The purpose of this study is to assess whether certain Emergency Department patients at high risk of recurrent falls and injuries related to falls will benefit from the recommendations of the Center for Disease Control and Prevention's (CDC) Stopping Elderly Accidents, Deaths and Injuries program (STEADI Program).

Study subjects will be randomized to one of 3 arms: 1) current care; 2) a phone-based fall-prevention strategy; or 3) a home-visit fall prevention strategy

1. Current emergency department care
2. STEADI recommendations administered via phone at 14 days
3. STEADI recommendations administered via a home visit at 14 days

The STEADI recommendations include the following:

* Follow-up with a primary care physician
* An assessment of your risk of falling. This includes looking at your ability to walk, your strength and balance.
* Assessment medications looking for potential medication interactions
* Measuring your vital signs (blood pressure and heart rate)
* Assessment of your vision
* Assessment of your footwear
* Recommendations to improve home safety (such as ensuring proper lighting, ensuring adequate hand-rails, and others)

Initial data collection will occur at the time of the ED visit. Intervention will occur 14 days after ED visit. Telephonic follow-up will occur at 3 months and 6 months after study enrollment.

Data will be collected from the patients/patient representatives and medical records. All data will be collected by trained research assistants (RAs)

Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 65 with a ground level fall who live at home will be eligible for study inclusion

Exclusion Criteria:

* Being transferred from another facility, trauma activation, hospice or palliative care participant, end-stage heart failure (two or more congestive heart failure hospitalizations in past 6 months), end stage emphysema (two or more chronic obstructive pulmonary disease hospitalizations in past 6 months), metastatic cancer, severe leukemia or multiple myeloma or lymphoma on treatment or requiring transfusion and end stage renal disease requiring dialysis. An additional exclusion criterion is patients with dementia, if the subject is unable to state name or unable to point to an object (for those with aphasia)
Vitamin D Deficiency in Obese Adolescent Girls and Influence of Vitamin D on Insulin Secretion and Sensitivity

Sub-clinical vitamin D deficiency is a commonly unrecognized disorder in obese adolescents. The investigators hypothesize vitamin D deficiency will be highly prevalent in obese adolescents and those who are vitamin D deficient will be more insulin resistant.

This is a cross-sectional study of obese female adolescents matched for age, sex and pubertal staging. Serum 25-OH vitamin D, intact PTH , lipid profile, serum CRP measurements and oral glucose tolerance tests (with glucose and insulin level measurements) will be done to assess the prevalence of vitamin D deficiency and to assess the insulin sensitivity- resistance indices.

Eligibility Criteria:
Inclusion Criteria:

* Female adolescents
* Obese: BMI \> 95th percentile
* Menarchal
* Tanner stage ≥ 4

Exclusion Criteria:

* Children with diabetes, other endocrine or acute or chronic medical illnesses, children on oral contraceptive pills, diuretics and anticonvulsant medications
Safety, Tolerability and Pharmacokinetics of Single Dose Intravenous Moxifloxacin in Pediatric Patients

The purpose of this study is to describe the pharmacokinetics of moxifloxacin in children to see what the best dose should be for children in the future. Pharmacokinetics is to see how the body absorbs, distributes, breaks down and gets rid of the study drug. The pharmacokinetics of certain drugs may be altered in children due to developmental differences in various organ functions responsible for drug elimination, as well as in general distribution characteristics. The safety of moxifloxacin in children with infections will also be looked at. Results from this study will be used to guide dosing strategies of the larger clinical trial planned for children


Eligibility Criteria:
Inclusion Criteria:

* Males or females, ages 3 months through 14 years inclusive
* Receiving antibiotics for suspected or proven infection

Exclusion Criteria:

* Body weight greater than 45 kg
* Patients taking anti-seizure medications within 30 days of moxifloxacin dosing
* Known or suspected allergy to quinolones
* History of tendon disease/disorder related to quinolone treatment
* Severe, life-threatening disease with a life expectancy of less than 48 hours and/or known rapidly fatal underlying disease (death expected within 2 months)
* Abnormal musculoskeletal evaluation at baseline assessment; or chronic musculoskeletal disease (eg, juvenile rheumatoid arthritis); or chronic illness with high risk for chronic or recurrent arthritis or tendinitis (eg, cystic fibrosis, chronic inflammatory bowel disease)
* Cardiac arrhythmia
* Evidence of renal or hepatic disease, based on laboratory findings (serum creatinine, total bilirubin, or ALT, \> 1.5 times upper limit of normal) and physical exam
* Patients receiving Class IA (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmic agents
* Patients taking any medication known to increase the QT interval, eg, amiodarone, astemizole, bepridil, chloroquine, chlorpromazine, cisapride, disopyuramide, dofetilide, droperidol, halofantrine, haloperidol, ibutilide, levomethadyl, mesoradazine, methadone, pimozide, procainamide, quinidine, sotalol, terfenadine
* Pregnancy
* Clinically relevant findings in the ECG
* Participation in another clinical study during the preceding 30 days1 (last treatment from previous study to first treatment of new study)
* Criteria which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the patient's safety
* Patients taking another fluoroquinolone at the time of planned moxifloxacin dosing
Comparisons of gaIt aNalyses pERformance Between the Gaitrite walkwaYs

The GAITRite® system is an instrumented with resistive pressure sensors gait analyzer. It was first validate in 2001 against paper-and-pencil (intraclass correlation coefficient \[ICC\] \> 95%) for spatial measures and against video-based (ICC \> 93%) for temporal measures, and was thus a reliable tools to measure step lengths and times in both walkway center and left-of-center measurements. It was considered as one of the gold standards in gait analyses. This gait analyze system may distinguish prospectively faller and non-faller older adults, but it can detect spatial, temporal, and spatiotemporal measures of gait and greater variability of gait parameters which were associated with and predictive of both global- and domain-specific cognitive decline. Moreover, spatiotemporal gait parameters analyzed using GAITRite® were more disturbed in the advanced stages of dementia, and more affected in the non-AD dementia than in AD suggesting that quantitative gait parameters could be used as a surrogate marker for improving the diagnosis of dementia.

Nevertheless, GAITRite® is not a unique system and it comprises different walkways. One of these technologies was a roll-up system (platinum plus classic, RE, Basic and Safari), and the other was a system composed by a changeable association of plates (CIRFACE). In order to ensure a good comparability between studies using these different walkways, it appears important to compare the performances of these walkways in gait analysis. Thus, the main aim of this study was to compare the performances in gait analyze between the GAITRite® platinum plus classic and the GAITRite® CIRFACE among older adults. Secondary aims were to compare these parameters among patients with cognitive complaint, minor or major neurocognitive disorder (NCD) related to Alzheimer disease.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 75 years
* Gait analysis performed with the two walkways superimposed during a consultation or day hospitalization

Exclusion Criteria:

* Opposition to the use of the information collected for research purposes
Effects of Mindfulness Meditation on Rhinoplasty Outcomes

A key factor in determining success of facial plastic plastic surgery is overall patient satisfaction. While a number of patient-reported outcomes tools has been developed, there is still limited research in how physicians can improve patient satisfaction and post-operative outcomes.

The goal of this study is to investigate the effect of a mindfulness meditation phone application on rhinoplasty outcomes. This study will also explore whether mindfulness meditation is a feasible adjunct to current pharmacological modalities of postoperative pain control as well as its potential impact on patient satisfaction. These questions will be answered using a randomized controlled trial.

The field of facial plastic surgery continues to grow as evidenced by the increasing number of services sought by both men and women each year. Among these procedures, rhinoplasty remains one of the most popular surgeries, ranking in the top three most performed cosmetic surgical procedures according to the 2017 Plastic Surgery Statistics Report. A key factor in determining the success of rhinoplasty is overall patient satisfaction. Although many patient-reported outcomes tools have been developed in this space, there is a paucity of research aimed at understanding how physicians can improve patient satisfaction in this patient population. Moreover, strategies to address the psychologic and coping ability for patients undergoing facial plastic surgery have not been investigated. To better provide patient-centered care, physicians should seek to understand the psychosocial impact of perceived nasal deformity and identify patients who may benefit from additional support interventions to complement current rhinoplasty treatment plans.

This is a prospective repeated measures study examining psychosocial status as measured by validated psychometric instruments. The intervention group will participate in mindfulness meditation using a phone application. Assessment of social functioning and quality of life will be conducted using survey instruments.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age or older
* Patients who will undergo rhinoplasty
* Patients with access to a smart-phone

Exclusion Criteria:

* Patients younger than 18 years of age
* Non-English speakers
* Patients without smart-phone access
Comparison of ProSeal Laryngeal Mask Airway to Laryngeal Mask Airway Supreme

Laryngeal mask airway is a widely used device in routine anesthesia for airway management during surgery. It consists of a tube with an inflatable cuff that is inserted into the mouth after induction of general anesthesia. The Proseal Laryngeal mask airway and the Laryngeal mask airway Supreme are two variants of the Laryngeal mask airway. The laryngeal mask airway Supreme is a newer version of the laryngeal mask airway.

The research is being done to compare two variants of the laryngeal mask airway: the Proseal laryngeal mask airway and the Laryngeal mask airway Supreme. This study will determine if the newer model, the Laryngeal mask airway Supreme, is easier to insert and is better positioned than the older model, the Proseal laryngeal mask airway. Both models are approved for use by the FDA, and are routinely used to assure the airway during general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* 18 - 75 years
* ASA I and II
* Mallampatti class: I and II
* Thyromental distance \> than 6.5 cm
* Interincisor distance \> than 3 cm
* BMI \< 35 Kg/m2
* Patients scheduled to undergo anesthesia with an LMA for minor extraperitoneal surgical procedures in supine position

Exclusion Criteria:

* Weight \< 50 kg
* BMI \> 35 Kg/m2
* Pregnant patients
* Known or expected difficult airway
* Patients with active, untreated and unresolved gastroesophageal reflux
* Esophageal pathology, pulmonary pathology
* Laparoscopic procedures
* ENT procedures, gastrointestinal procedures, intraperitoneal surgical procedure
Immuno-Oncology Drugs GLS-012 Alone & in Combination GLS-010 Treating With Advanced Patients Solid Tumors

This is a phase I/II study to investigate the safety, tolerability, and preliminary efficacy of GLS-012 monotherapy and in combination with GLS-010 in subjects with advanced solid rumor after progression on standard treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who are willing to sign the informed consent form;
2. Aged 18-75 years, male or female;
3. Histologically confirmed diagnosis of a solid tumor;
4. Patients with advanced solid tumors after progression on standard treatment;
5. Subjects must have at least 1 measurable target lesion according to RECIST version 1.1；
6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1；
7. Life expectancy more than 12 weeks;
8. Adequate organ function and bone marrow function as indicated by the screening assessments in the screening period;
9. Women of childbearing potential must use highly effective contraception during the study period and at least 6 months after the last study drug administration, and must have a negative blood pregnancy test within 3 days before study enrollment.

Exclusion Criteria:

1. Patients with irAEs of grade ≥ 3 in the previous immunotherapy, and the AEs of the last anti-tumor treatment have not recovered to grade ≤ 1, except for hypothyroidism/hyperthyroidism and dermatitis that have recovered to grade ≤ 2, and AEs with no safety risks judged by the investigators, for example, alopecia.
2. Patients with primary or secondary immunodeficiency, or patients who are receiving long-term systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before randomization.
3. Use of corticosteroids or other immunosuppressants for systemic treatment within 14 days before the first study drug administration;
4. Known central nervous system (CNS) metastases;
5. Patients with severe hypersensitivity to macromolecular protein preparations/monoclonal antibodies in the past.
6. Patients with other malignant tumors within 5 years before screening, except cured cervical carcinoma in situ and cured skin basal cell carcinoma.
7. Cardiac clinical symptoms or diseases that are not well controlled.
8. Known hereditary or acquired bleeding and thrombosis tendency.
9. Patients with congenital or acquired immunodeficiency disorders (such as HIV-infection), or a history of organ transplantation.
10. Patients complying with any of hepatitis B surface antigen (HBsAg) positive and HBV-DNA copies being more than 2500 copies/ml (or 500 IU/ml); or positive HCV-RNA;
11. Patients with poor compliance or other conditions that are not suitable to participate in the clinical trial, as considered by the investigator.
Three-Dose Regimen of MRKAd5+6 Trigene (V526) in Healthy Adults (V526-001)(COMPLETED)

A study to assess the general safety and tolerability of the administration of the 3-dose regimen of the MRKAd5+6 trigene vaccine


Eligibility Criteria:
Inclusion Criteria:

* Subject has negative tests for HIV, Hepatitis B, and Hepatitis C within 60 days of injection
* Subject agrees to use an acceptable method of birth control through week 52 of the study

Exclusion Criteria:

* Subject has been given immune globulin or blood products within 30 days of first dose of study vaccine
* Subject has been vaccinated with a live virus vaccine within 30 days or an inactivated vaccine within 5 days of first dose of study vaccine
* Subject has known or suspected impaired immune function
* Subject has participated in any other HIV vaccine trial
* Female subject is pregnant or breastfeeding
A Study To Monitor Long-Term Treatment With PF-00547659

This study provides open-label drug to eligible patients who have completed a prior study of PF-00547659. The primary endpoint for this study is long-term safety.

The rationale for conducting this open-label extension (OLE) study is primarily to evaluate long term safety of PF 00547659. This protocol also provides the opportunity for continued treatment for subjects responding to treatment from the feeder study. It also provides an opportunity for initial treatment for subjects randomized to placebo in the feeder study. This is a multi center Phase 2, open label, safety extension study for feeder studies which evaluate PF 00546759 in subjects with moderate to severe Crohn's disease. Subjects eligible for this study will have completed the 12 week double blind induction period in study A7281006 and will be stratified by responders or non responders based on change in CDAI in that study, without unblinding treatment assignment from study A7281006. Additionally, subjects who have completed study A7281008 with a clinical response, as defined by that protocol, will also be eligible for this study and treated as "responders". All subjects entering this study must have discontinued immunosuppressant therapy.

Subjects entering this study will be given a 75 mg SC dose at baseline and then every 4 weeks through Week 72. After the active treatment period, the subjects will enter a 24 month follow up period including 6 monthly visits followed by 18 month extended contact (every 6 month telephone contacts). At Week 96, subjects will undergo an End of Study visit but will continue the every 6 month telephone contacts until Week 168.

Eligibility Criteria:
Inclusion Criteria:

* Subjects between 18 and 76 years of age.
* Subjects previously enrolled in study A7281006 who have completed the blinded 84 day (12 week) induction period or in study A7281008 who have completed Week 12 and have demonstrated a clinical response as defined by that protocol.

Exclusion Criteria:

* Subjects that have completed Day 84 (Week 12) of a PF-00547659 study but have experienced serious event(s) related to the investigational product, an unstable medical condition, or any other reason, in the opinion of the investigator, would hinder entry or participation in this study.
* Subjects who are taking any dose of azathioprine, 6-mercaptopurine or methotrexate.
A Study Evaluating the Efficacy and Safety of CKD-314 (Nafabelltan) in Hospitalized Adult Patients Diagnosed With COVID-19 Pneumonia

The primary objective of this study is to evaluate the efficacy of CKD-314 (Nafabelltan) compared to standard of care (SOC), with respect to clinical status assessed by a 7-point ordinal scale in hospitalized adult patients diagnosed with COVID-19 pneumonia


Eligibility Criteria:
Inclusion Criteria:

* Men and women Aged ≥18 years
* Hospitalized subjects who have confirmed COVID-19 infection and have evidence of pneumonia:
* Subjects who are eligible for diagnosis/evaluation to chest X-ray or chest CT
* Women of childbearing potential (including women in post menopause for less than 2 years) must use a medically acceptable forms of birth control and agree to continue its use during the study
* Subjects (or legally authorized representative) should be able to understand and agree to comply with the clinical trial and to provide a written consent document prior to initiation of any study procedure

Exclusion Criteria:

* Subjects who have a record of HIV or AIDS
* Subject has a serious chronic disease
* Active bleeding or ongoing clinical condition deemed at high risk of bleeding contraindicating anticoagulant treatment
* Pregnant or lactating females
* Subjects with liver cirrhosis whose Child-Pugh score is B or C
* Subjects who have liver disease abnormalities with ALT or AST \> 5 times ULN
* Estimated glomerular filtration rate (eGFR) \< 30 ml/min (including patients receiving hemodialysis or hemofiltration)
* QTcB or QTcF \>500ms
* Subjects who have clinically significant ventricular arrhythmias (ventricular tachycardia, ventricular fibrillation) in medical history
* Subjects with rapidly deteriorating clinical condition or low likelihood to complete the study according to the investigator's opinion
* Subjects who are not appropriate for the study, as the investigator's opinion
* Subjects who have hypersensitivity to the investigational drug
* Subjects participated in any other clinical trial (including drugs for the treatment of COVID-19) 3 months prior to screening
The Impact of Rosuvastatin on the Density Score of Coronary Artery Calcification in CAD Patients With Diabetes Mellitus

This study is designed to validate the hypothesis that the treatment of rosuvastatin could increase the score of Calcification of Coronary artery(CAC) density in coronary artery disease(CAD) patients with diabetes mellitus.CAD patients with diabetes who confirmed CAC will receive rosuvastatin (20mg/d) therapy for 24 months.

Calcification of atherosclerotic plaque is a complicated and organic active process, which is one of the main pathologic features of atherosclerosis. Widely coverage of CAC is correlated with the greater likelihood of coronary events.With the increasing density of CAC, the risk of cardiovascular disease (CVD) declines.Some studies showed that the calcified plaque in stable CHD is denser.

Statins are widely used in the treatment of atherosclerotic cardiovascular disease. Treatment of statins may increase the density score of CAC, thus, promote the unstable atherosclerotic plaque to the stable plaque.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of informed consent prior to any study specific procedures
2. Male and female adults aged 18-70 years old
3. CHD patients without stent implantation determined by coronary angiography or coronary CT examination;
4. Combined with type 2 diabetes: HbA1c≥6.5%, FPG≥7.0mmol/L, 2h blood glucose≥11.1mmol/L
5. Patients who confirmed CAC(Agatston score ≥50,measured by 64 row spiral CT6)

Exclusion Criteria:

1. CHD Patients plan to recieve coronary stenting implantation or coronary artery bypass grafting;
2. Patients combined with severe pulmonary, liver and kidney dysfunction
3. Classed as III-IV grade of New York Heart Association functional
4. Pregnancy test was positive，lactation woman and in women of child-bearing potential not using appropriate contraceptive measures.
5. Life expectancy within 24 months or less
6. Patients combined valvular heart disease and cardiomyopathy
7. Patients combined cancer
8. Patients with atrial fibrillation
9. Patients who is allergic to statins
10. Patients with myopathy
11. Patients with active liver disease
Echocardiographic Assessment of the Impact of Diabetes and Prognostic Analysis of Heart Transplantation

The aim of this study is to evaluat the impact of diabetes on cardiac function in patients with heart transplantation by multimodal imaging and analyse their prognosis.

This study is planed to enroll 300000 patients after heart transplantation, all the patients will be divided into 3 groups according to whether or not they have diabetes and when did they develop diabete. Echocardiography will be used to evaluat their cardiac function. Comparing their cardiac function and clinical information and analysing their prognosis to evaluat the impact of diabetes.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients who received a heart transplant after 2015

Exclusion Criteria:

* The image quality is poor